MAP: Restoring Masticatory Function to Treat Chronic Pain
Sponsor
Urbano Santana Penin, MD, DDS, PhD (Other)
Overall Status
Terminated
CT.gov ID
NCT02144233
Collaborator
University of Santiago de Compostela (Other)
77
2
2
46.5
38.5
0.8
Study Details
Study Description
Brief Summary
The primary endpoint will be the average change in pain score from baseline to the three- and six-month assessments. Efficacy will be demonstrated by superior pain relief with the active treatment compared with the placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
-
The cause of temporomandibular joint (TMJ) disorders (TMD) remains unknown and therapy is usually empirical. Systematic reviews have concluded that currently there is no evidence that occlusal adjustment has any therapeutic or preventive effect on temporomandibular disorders. However, these reviews also indicate that evidence to the contrary has not been provided and that more research is needed to elucidate whether there is any benefit of occlusal adjustment treatment for TMD. The risk factors for chronic unilateral TMD include a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the affected side. Consequently, a new occlusal therapy is proposed to restore the physiological jaw closure and masticatory function.
-
The primary end point of the trial is to assess the efficacy of the new occlusal therapy on the affected side TMD pain, and the maximum mouth opening. Efficacy is demonstrated by showing significantly superior pain relief and increasing maximum mouth opening (when it was limited) with the active treatment compared with placebo.
Phase III, single center, randomized, parallel-group, single-blind with blinded assessment, placebo-controlled clinical trial.
-
A linear mixed model will be performed for comparisons of most variables and a logistic regression model will be used to measure the probability/risk of change on the chewing side between baseline and six months; in addition, McNemar's test may be used.
-
Interim analysis plan and stopping rules. The study will employ an interim analysis plan with a single interim analysis after 70% of participants have completed the six-month follow-up visit. Using the Lan-DeMets version of the O'Brien-Fleming stopping rule, the critical value for statistical significance at the interim analysis (under intention-to-treat approach) will be +2.438, corresponding to a nominal two-sided P value of 0.0146.
Participants remaining with significant pain (and/or limited mouth opening) after the study will be invited to follow the conventional treatment, or to "complete" occlusal adjustment (rescue therapy): the full adjustment (if they were placebos), or a refining (if they received real therapy); the kind of received therapy will not be disclosed to participants. It based on the researchers' conviction, participants are encouraged to receive electively "complete" occlusal adjustment. All participants will be reevaluated between 3 to 6 months after study (12-Mo follow-up). Although no pain was reported at the 6-Mo follow-up, if pain returns, same approach will be carried out. Two sessions occlusal adjustment will be carried out and, if the pain remains, the patient will be treated following the Hospital approaches. The evolution of patients during post-MAP period, until writing of the manuscript, will be reported in the same manuscript, even if MAP result early stopped.
Additional patient's monitoring until next five years after treatment is expected.
Study Design
Study Type:
Interventional
Actual Enrollment
:
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Restoring Masticatory Function as Treatment for Chronic Pain: a Randomized Placebo-controlled Trial
Actual Study Start Date
:
Aug 1, 2014
Actual Primary Completion Date
:
Jun 15, 2018
Actual Study Completion Date
:
Jun 15, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Occlusal adjustment therapy Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. |
Procedure: Occlusal adjustment
The first step consists of the elimination of premature tooth contacts during retruded jaw closure.
The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)
Other Names:
|
| Placebo Comparator: Placebo occlusal adjustment therapy Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
Procedure: Placebo occlusal adjustment
Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
|
Outcome Measures
Primary Outcome Measures
- Jaw-pain-Intensity (Affected Side) [Baseline and 6-months]
Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome.
Secondary Outcome Measures
- Chewing Side [Baseline and 6-months]
A consistent chewing side was considered if at lees 5 out of 7 almonds (or at lees 7 of 10 cycles of chewing gum), the participant report to use same side, and same side was used during kinesiography recordings of spontaneous chewing. Any other results lead to alternate chewing allocation.
- Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) [Baseline, 6-Months]
Mean change in Global Severity Index scores from a self-administered Spanish validated questionaire SCL-90-R. Higher values represent a worse outcome. Range (0-4).
- Maximum Unassisted Jaw Opening [Baseline, 3- and 6-Months]
Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome.
Other Outcome Measures
- Headache-intensity [Baseline 3- and 6-Months]
Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain.
- Number of Participants With Neuropathic Pain [Baseline, 6-Months]
Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain.
- Handedness Preference [Baseline]
Handedness preference assessed using Edinburg inventory: Left Right Writing Drawing Throwing Scissors Toothbrush Knife (without fork) Spoon Broom (upper hand) Striking Match (match) Opening box (lid) I Which foot do you prefer to kick with? II Which eye do you use when using only one?
- Lateral Guidance Angles (LG) [Baseline]
The angle between the tangent of the LG tracings and the horizontal Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system. Both sides recordings of each patient were measured and considered individually. The mean of both sides of each patient was not used.
- Condylar Path Angles [Baseline]
Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method.
- Adverse Events [After therapy, 1-Month, 3-Months, 6-Months]
Unexpected Adverse Events (NIH, 2009).
- Jaw Asymmetry [Baseline]
Over 1 mm of interincisal midline deviation and inter-arches Angle Classification of the lateral sectors (canines and first molars); it will be assessed during maximal intercuspal position and during jaw retruded contact position
- Participant's Awareness With Trial Group Assignment [Six months]
Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved
- Credibility (of Participants) [Baseline, 6-Months]
Confidence of participants in the goodness of treatment. These items were simplified here to the following single question: How confident would you be that this treatment would be successful in eliminating your pain and/or limited mouth opening? 0-10 numerical rating scale, with 0=nothing to 10= totally.
- Sociodemography [Baseline]
Level of education
- Patient Impression (Improvement) [6-Months]
Patient impression outcome will be reported as Improved Vs. no change.
- Pain Interference on Daily Activity [Baseline; 6-Months]
In the past 6 months, how much has facial pain interfered with your daily activities rated on a 0-10 scale where 0 is "no interference" and 10 is "unable to carry on any activities"? 0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities). N.B. Only one item was choose to simplify.
- Pain-dimensions [Baseline, 6-Months]
McGill Pain questionnaire
- Temporomandibular Disorders Related Impairment [Baseline, 6-Mo]
Mandibular Function Impairment Questionnaire (MFIQ)
- Circulating Biomarkers [Baseline, 6-Months]
Blood levels of Circulating Biomarkers
- Periodontal Disease (if Indicated) [Baseline, 6-Months]
Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility
- Occlusal Forces/Pressure [Baseline; 6-Months]
Dental or occlusal forces measured using fuji-film method.
- Maximum Comfortable (Without Pain) Jaw Opening [Baseline, immediate after therapy, 3- and 6-Months]
Vertical jaw-opening (incisal level) measured using a ruler.
- Patient's Perception of Reduced Movement [Baseline, 6-Months]
Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome.
- Protrusive Motion [Baseline, 6-Months]
Magnitude (mm) of protrusive jaw-movement (incisal level) and lateral shift (quantitative, mm; and/or qualitative, left/right), using kinesiography recordings. Higher values represent a better outcome.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Completely dentate (except for the third molars; including if they were treated before enrollment by conventional or implant-supported fixed prosthesis allowing similar potential comfortable chewing on both sides)
-
Normal Angle Class I occlusion
-
Self-reported pain-intensity scores from 4 to 9 in a 0-10 visual analogue scale (VAS) or numerical pain rating scale (NRS).
-
Chronic (over 6 months) joint and/or muscle pain, according to diagnostic criteria for temporomandibular disorders (DC/TMD), for which they had requested therapy
Exclusion Criteria:
-
Psychosis
-
Major depression
-
Substance abuse
-
Cognitive impairment
-
Addiction to morphine or derivates
-
Litigation or asking for disability/retirement compensation for chronic pain
-
Dental care professionals
-
Orthodontic therapy during the last 2 years
-
Patients with any pain that is more severe, in the same location as, or cannot be clearly distinguished from TMD pain
-
Individuals for whom minimally invasive occlusal adjustment could not achieve occlusal equilibration, including: Over 2 mm of difference between the maximal intercuspal position and the centric occlusion or over 4 mm of difference between upper and lower archs (or over 2mm on at less one side) measured: between the mesial fosses of first upper premolars with respect the buccal cusps of the first lower premolars; and/or between the mesiopalatal cusp of the first upper molars respect to the central (mesial) fossae of the first lower molar.
-
Severe periodontal disease with grade 3 mobility
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidad de Santiago de Compostela | Santiago de Compostela | A Coruña, Galicia | Spain | 15782 |
| 2 | Complexo Hospitalario Universitario A Coruña | A Coruña | A Coruña. Galicia | Spain | 15006 |
Sponsors and Collaborators
- Urbano Santana Penin, MD, DDS, PhD
- University of Santiago de Compostela
Investigators
- Principal Investigator: Urbano Santana-Penin, Prof, University of Santiago de Compostela
- Study Chair: Jose Lopez-Cedrun, Dr, University Hospital Complex of La Coruña
- Study Director: Maria J Mora, Prof, University of Santiago de Compostela
- Principal Investigator: Urbano Santana-Mora, Dr, University of Santiago de Compostela
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
Urbano Santana Penin, MD, DDS, PhD,
Prof.,
University of Santiago de Compostela
ClinicalTrials.gov Identifier:
NCT02144233
Other Study ID Numbers:
- U1111-1134-0832
- PI11/02507
- ISRCTN
First Posted:
May 21, 2014
Last Update Posted:
Apr 22, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Urbano Santana Penin, MD, DDS, PhD,
Prof.,
University of Santiago de Compostela
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Period Title: Overall Study | ||
| STARTED | 39 | 38 |
| COMPLETED | 39 | 38 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy | Total |
|---|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance angle on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. | Total of all reporting groups |
| Overall Participants | 39 | 38 | 77 |
| Age (years) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [years] |
29
|
30
|
30
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
37
94.9%
|
35
92.1%
|
72
93.5%
|
| Male |
2
5.1%
|
3
7.9%
|
5
6.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
2.6%
|
2
5.3%
|
3
3.9%
|
| White |
38
97.4%
|
36
94.7%
|
74
96.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Self-reported jaw-pain intensity (units on a 0-10 scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a 0-10 scale] |
7
|
7
|
7
|
Outcome Measures
| Title | Jaw-pain-Intensity (Affected Side) |
|---|---|
| Description | Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome. |
| Time Frame | Baseline and 6-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| baseline |
7
|
7
|
| 6-Months |
2
|
3.5
|
| Title | Chewing Side |
|---|---|
| Description | A consistent chewing side was considered if at lees 5 out of 7 almonds (or at lees 7 of 10 cycles of chewing gum), the participant report to use same side, and same side was used during kinesiography recordings of spontaneous chewing. Any other results lead to alternate chewing allocation. |
| Time Frame | Baseline and 6-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| Right |
16
41%
|
14
36.8%
|
| Alternate |
8
20.5%
|
13
34.2%
|
| Left |
15
38.5%
|
11
28.9%
|
| Right |
6
15.4%
|
6
15.8%
|
| Alternate |
25
64.1%
|
27
71.1%
|
| Left |
8
20.5%
|
5
13.2%
|
| Title | Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) |
|---|---|
| Description | Mean change in Global Severity Index scores from a self-administered Spanish validated questionaire SCL-90-R. Higher values represent a worse outcome. Range (0-4). |
| Time Frame | Baseline, 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some self administered questionnaire was not adequately covered by the patient. |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| baseline |
0.89
(0.57)
|
0.81
(0.51)
|
| 6-Months |
0.52
(0.5)
|
0.5
(0.49)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Occlusal Adjustmen Therapy, Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.54 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Maximum Unassisted Jaw Opening |
|---|---|
| Description | Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome. |
| Time Frame | Baseline, 3- and 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| baseline |
41.5
(8.4)
|
43.9
(7.8)
|
| 3-Months |
45.66
(7.9)
|
46.73
(7.7)
|
| 6-Months |
47.7
(8.4)
|
46.4
(7.7)
|
| Title | Headache-intensity |
|---|---|
| Description | Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain. |
| Time Frame | Baseline 3- and 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| baseline |
7
|
5.75
|
| 3-Months |
4
|
3
|
| 6-Months |
4
|
3
|
| Title | Number of Participants With Neuropathic Pain |
|---|---|
| Description | Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain. |
| Time Frame | Baseline, 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from 1 placebo group participant at 6-months not available |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 37 |
| neuropathic pain |
13
33.3%
|
12
31.6%
|
| without neuropathic symptoms |
26
66.7%
|
25
65.8%
|
| neuropathic pain |
3
7.7%
|
4
10.5%
|
| without neuropathic symptoms |
36
92.3%
|
33
86.8%
|
| Title | Handedness Preference |
|---|---|
| Description | Handedness preference assessed using Edinburg inventory: Left Right Writing Drawing Throwing Scissors Toothbrush Knife (without fork) Spoon Broom (upper hand) Striking Match (match) Opening box (lid) I Which foot do you prefer to kick with? II Which eye do you use when using only one? |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| right |
29
74.4%
|
31
81.6%
|
| left |
10
25.6%
|
7
18.4%
|
| Title | Lateral Guidance Angles (LG) |
|---|---|
| Description | The angle between the tangent of the LG tracings and the horizontal Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system. Both sides recordings of each patient were measured and considered individually. The mean of both sides of each patient was not used. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Note that both sides of each participant was assessed. Recordings from one participant in each group are unavailable. |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 38 | 37 |
| Measure LG | 76 | 74 |
| Mean (Standard Deviation) [degrees] |
42
(10.3)
|
40.6
(11.8)
|
| Title | Condylar Path Angles |
|---|---|
| Description | Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| right joint |
50.5
(10.7)
|
47.3
(8.1)
|
| left joint |
50.1
(10.5)
|
49.3
(8.6)
|
| Title | Adverse Events |
|---|---|
| Description | Unexpected Adverse Events (NIH, 2009). |
| Time Frame | After therapy, 1-Month, 3-Months, 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Jaw Asymmetry |
|---|---|
| Description | Over 1 mm of interincisal midline deviation and inter-arches Angle Classification of the lateral sectors (canines and first molars); it will be assessed during maximal intercuspal position and during jaw retruded contact position |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Participant's Awareness With Trial Group Assignment |
|---|---|
| Description | Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved |
| Time Frame | Six months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| real therapy |
26
66.7%
|
21
55.3%
|
| I don't' know |
12
30.8%
|
14
36.8%
|
| placebo therapy |
1
2.6%
|
3
7.9%
|
| Title | Credibility (of Participants) |
|---|---|
| Description | Confidence of participants in the goodness of treatment. These items were simplified here to the following single question: How confident would you be that this treatment would be successful in eliminating your pain and/or limited mouth opening? 0-10 numerical rating scale, with 0=nothing to 10= totally. |
| Time Frame | Baseline, 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from one participant from each group was lost from baseline, and 2 from the Occlusal adjustment group and 5 from the placebo group at 6-months. |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 37 | 33 |
| baseline |
8
(1.8)
|
8.3
(1.3)
|
| 6-Months |
8
(1.9)
|
7.6
(2.6)
|
| Title | Sociodemography |
|---|---|
| Description | Level of education |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 38 |
| Higher |
21
53.8%
|
26
68.4%
|
| Secondary |
12
30.8%
|
9
23.7%
|
| No qualifications |
6
15.4%
|
3
7.9%
|
| Title | Patient Impression (Improvement) |
|---|---|
| Description | Patient impression outcome will be reported as Improved Vs. no change. |
| Time Frame | 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from two participants in placebo group that underwent randomization were not available. |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 39 | 36 |
| Improved |
37
94.9%
|
25
65.8%
|
| No change |
2
5.1%
|
11
28.9%
|
| Title | Pain Interference on Daily Activity |
|---|---|
| Description | In the past 6 months, how much has facial pain interfered with your daily activities rated on a 0-10 scale where 0 is "no interference" and 10 is "unable to carry on any activities"? 0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities). N.B. Only one item was choose to simplify. |
| Time Frame | Baseline; 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from two occlusal adjustment and six placebo group participants were not available. |
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy |
|---|---|---|
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Measure Participants | 37 | 32 |
| baseline |
5.2
(2.6)
|
4.5
(2.9)
|
| 6-Months |
3.1
(2.6)
|
2
(3.2)
|
| Title | Pain-dimensions |
|---|---|
| Description | McGill Pain questionnaire |
| Time Frame | Baseline, 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Temporomandibular Disorders Related Impairment |
|---|---|
| Description | Mandibular Function Impairment Questionnaire (MFIQ) |
| Time Frame | Baseline, 6-Mo |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Circulating Biomarkers |
|---|---|
| Description | Blood levels of Circulating Biomarkers |
| Time Frame | Baseline, 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Periodontal Disease (if Indicated) |
|---|---|
| Description | Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility |
| Time Frame | Baseline, 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Occlusal Forces/Pressure |
|---|---|
| Description | Dental or occlusal forces measured using fuji-film method. |
| Time Frame | Baseline; 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Maximum Comfortable (Without Pain) Jaw Opening |
|---|---|
| Description | Vertical jaw-opening (incisal level) measured using a ruler. |
| Time Frame | Baseline, immediate after therapy, 3- and 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Patient's Perception of Reduced Movement |
|---|---|
| Description | Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome. |
| Time Frame | Baseline, 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Protrusive Motion |
|---|---|
| Description | Magnitude (mm) of protrusive jaw-movement (incisal level) and lateral shift (quantitative, mm; and/or qualitative, left/right), using kinesiography recordings. Higher values represent a better outcome. |
| Time Frame | Baseline, 6-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The dental hypersensitivity period (referred to as discomfort to the chewing foods crisp) lasted between 1 and 3 months. | |||
| Arm/Group Title | Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy | ||
| Arm/Group Description | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. | ||
All Cause Mortality |
||||
| Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/39 (0%) | 0/38 (0%) | ||
Serious Adverse Events |
||||
| Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/39 (0%) | 0/38 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Occlusal Adjustmen Therapy | Placebo Occlusal Adjustment Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/39 (7.7%) | 0/38 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Dental hypersensitivity | 3/39 (7.7%) | 3 | 0/38 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Professor Urbano Santana Penín |
|---|---|
| Organization | University of Santiago de Compostela. A Coruña. SPAIN |
| Phone | +34647344093 |
| urbano.santana@usc.es |
Responsible Party:
Urbano Santana Penin, MD, DDS, PhD,
Prof.,
University of Santiago de Compostela
ClinicalTrials.gov Identifier:
NCT02144233
Other Study ID Numbers:
- U1111-1134-0832
- PI11/02507
- ISRCTN
First Posted:
May 21, 2014
Last Update Posted:
Apr 22, 2020
Last Verified:
Apr 1, 2020