Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity
Study Details
Study Description
Brief Summary
This will be a single centre, two week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participant with at least two sensitive teeth that meet the study criteria at the Screening and Baseline visits. The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Stannous Fluoride Dentifrice Participants will be instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants will be permitted to rinse with tap water. |
Other: Stannous Fluoride Dentifrice
Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride)
|
| Other: Sodium monofluorophosphate Dentifrice Participants will be instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants will be permitted to rinse with tap water. |
Other: Sodium monofluorophosphate Dentifrice
Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Schiff Sensitivity Score at Day 14 [Baseline, Day 14]
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Secondary Outcome Measures
- Change From Baseline in Schiff Sensitivity Score at Day 7 [Baseline, Day 7]
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
- Change From Baseline in Tactile Threshold at Day 7 and Day 14 [Baseline, Day 7 and Day 14]
A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
-
Aged 18-65 years inclusive.
-
Good general and mental health with:
No clinically significant and relevant abnormalities of medical history or oral examination.
Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
-
Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
-
Minimum of 20 natural teeth.
-
Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria at screening: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
Tooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1.
Tooth with signs of sensitivity measured by qualifying evaporative air assessment (yes[Y]/No[N] response).
- Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria at screening:
Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).
Exclusion Criteria:
-
Women who are breast-feeding, known to be pregnant or who are intending to become pregnant over the duration of the study.
-
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
-
Previous participation in this study or participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
-
Recent history (within the last year) of alcohol or other substance abuse.
-
Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or causing xerostomia.
-
Dental prophylaxis within 4 weeks of Screening.
-
Tongue or lip piercing or presence of dental implants.
-
Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
-
Teeth bleaching within 8 weeks of Screening.
-
Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
-
Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.
-
Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice.
-
Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening.
-
Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
-
Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline.
-
Daily dose of a medication which, in the opinion of the Investigator, is causing xerostomia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Mississauga | Ontario | Canada | L4W 0C2 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 205201
Study Results
Participant Flow
| Recruitment Details | Participants were recruited at a single center in Canada. |
|---|---|
| Pre-assignment Detail | A total of 143 participants were enrolled in the study. Out of which 141 participants were randomized. |
| Arm/Group Title | Stannous Fluoride Dentifrice | Sodium Monofluorophosphate Dentifrice |
|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. | Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. |
| Period Title: Overall Study | ||
| STARTED | 71 | 70 |
| COMPLETED | 71 | 70 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Stannous Fluoride Dentifrice | Sodium Monofluorophosphate Dentifrice | Total |
|---|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. | Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. | Total of all reporting groups |
| Overall Participants | 72 | 69 | 141 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
47.7
(10.27)
|
48.0
(10.58)
|
47.9
(10.39)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
55
76.4%
|
50
72.5%
|
105
74.5%
|
| Male |
17
23.6%
|
19
27.5%
|
36
25.5%
|
Outcome Measures
| Title | Change From Baseline in Schiff Sensitivity Score at Day 14 |
|---|---|
| Description | Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. |
| Time Frame | Baseline, Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy. |
| Arm/Group Title | Stannous Fluoride Dentifrice | Sodium Monofluorophosphate Dentifrice |
|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. | Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. |
| Measure Participants | 71 | 70 |
| At Baseline |
2.70
(0.427)
|
2.74
(0.423)
|
| Change From Baseline at Day 14 |
-1.38
(0.843)
|
-0.10
(0.405)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Stannous Fluoride Dentifrice, Sodium Monofluorophosphate Dentifrice |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates. | |
| Method of Estimation | Estimation Parameter | Least square (LS) mean difference |
| Estimated Value | -1.29 | |
| Confidence Interval |
(2-Sided) 95% -1.509 to -1.071 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice. | |
| Title | Change From Baseline in Schiff Sensitivity Score at Day 7 |
|---|---|
| Description | Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. |
| Time Frame | Baseline, Day 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy. |
| Arm/Group Title | Stannous Fluoride Dentifrice | Sodium Monofluorophosphate Dentifrice |
|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. | Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. |
| Measure Participants | 71 | 70 |
| At Baseline |
2.70
(0.427)
|
2.74
(0.423)
|
| Change from baseline at Week 7 |
-0.74
(0.446)
|
-0.04
(0.374)
|
| Title | Change From Baseline in Tactile Threshold at Day 7 and Day 14 |
|---|---|
| Description | A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth. |
| Time Frame | Baseline, Day 7 and Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy. |
| Arm/Group Title | Stannous Fluoride Dentifrice | Sodium Monofluorophosphate Dentifrice |
|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. | Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. |
| Measure Participants | 71 | 70 |
| At Baseline |
11.83
(3.189)
|
11.50
(2.992)
|
| Change from Baseline at Day 7 |
5.92
(6.113)
|
0.86
(3.898)
|
| Change from Baseline at Day 14 |
15.21
(11.663)
|
0.86
(3.708)
|
Adverse Events
| Time Frame | From start of screening to 5 days following last administration of the study product (up to 39 days) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" & 69 participants in treatment arm "sodium monofluorophosphate dentifrice". | |||
| Arm/Group Title | Stannous Fluoride Dentifrice | Sodium Monofluorophosphate Dentifrice | ||
| Arm/Group Description | Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. | Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. | ||
All Cause Mortality |
||||
| Stannous Fluoride Dentifrice | Sodium Monofluorophosphate Dentifrice | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/72 (0%) | 0/69 (0%) | ||
Serious Adverse Events |
||||
| Stannous Fluoride Dentifrice | Sodium Monofluorophosphate Dentifrice | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/72 (0%) | 0/69 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Stannous Fluoride Dentifrice | Sodium Monofluorophosphate Dentifrice | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/72 (4.2%) | 0/69 (0%) | ||
| General disorders | ||||
| Pyrexia | 1/72 (1.4%) | 0/69 (0%) | ||
| Infections and infestations | ||||
| Influenza | 1/72 (1.4%) | 0/69 (0%) | ||
| Nervous system disorders | ||||
| Headache | 1/72 (1.4%) | 0/69 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
- 205201