Periodontal Infection and Endothelial Dysfunction
Sponsor
Universidad del Valle, Colombia (Other)
Overall Status
Completed
CT.gov ID
NCT00681564
Collaborator
(none)
102
2
2
44
51
1.2
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Periodontitis is one of the most prevalent chronic diseases and a frequent cause of tooth loss. Accumulation of subgingival dental biofilm in susceptible individuals is associated with an inflammatory host response characterized by the production of Matrix Metalloproteinases, reduction in collagen synthesis, increase in cytokine gene expression, and apoptosis of gingival fibroblasts. Finally, inflammation leads to destruction of periodontal ligament, alveolar bone resorption, and chronic periodontitis.
Periodontitis is associated with increased serum levels of inflammatory cytokines and acute phase reactants. Multiple case-control and cohort studies have suggested that periodontitis is an independent risk factor for cardiovascular events, diabetic end-organ damage, pregnancy complications and respiratory diseases. Recent interventional studies have found that periodontal therapy could increase endothelium-dependent brachial artery flow-mediated dilation.
The purpose of this controlled clinical trial is to determine the effect of periodontal therapy on endothelial function in subjects with moderate to severe chronic periodontitis. Furthermore, the relationship between putative periodontal pathogens and endothelial function will be also evaluated.
Study Design
Study Type:
Interventional
Actual Enrollment
:
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Impact of Periodontal Therapy on Endothelial Function
Study Start Date
:
May 1, 2008
Actual Primary Completion Date
:
Mar 1, 2011
Actual Study Completion Date
:
Jan 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: One-Stage Full-Mouth Disinfection Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) |
Procedure: One-Stage Full-Mouth Disinfection
Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
| Active Comparator: Periodontal care Basic oral hygiene instructions Supragingival plaque removal |
Procedure: Periodontal care
Basic oral hygiene instructions
Supragingival plaque removal
|
Outcome Measures
Primary Outcome Measures
- Brachial Artery Flow-mediated Dilation [Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy]
All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).
Secondary Outcome Measures
- High-sensitivity C-Reactive Protein [Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy]
The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).
- Total Cholesterol [Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy]
- White Blood Cell Count [Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy]
- Subgingival Microbiota [12 weeks post-periodontal therapy]
Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf).
- LDL Cholesterol [Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy]
- Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin) [12 weeks post periodontal therapy]
Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®). Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis.
- Intercellular Adhesion Molecule 1 (ICAM-1) [12 weeks post periodontal therapy]
- Vascular Cell Adhesion Molecule 1 (VCAM-1) [12 weeks post periodontal therapy]
- Myeloperoxidase (MPO) [12 weeks post periodontal therapy]
- Matrix Metalloproteinase-9 (MMP-9) [12 weeks post periodontal therapy]
- Tissue Plasminogen Activator Inhibitor-1 (tPAI-1) [12 weeks post periodontal therapy]
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Subjects must be 25 years of age or older
-
Three or more periodontal pockets with a probing depth (PD) > 5mm
-
Have at least 20 natural teeth
-
Provide informed consent and willingness to cooperate with the study protocol
Exclusion Criteria:
-
History of antibiotic use in the previous three months
-
Pregnant or lactating females
-
Treatment with antihypertensive, antilipemic, antiarrhythmic, and other cardiovascular drugs
-
Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
-
Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular block, peripheral vascular disease, cerebrovascular accident
-
Patients who received periodontal treatment within the last 3 months
-
Patients who require antibiotic prophylaxis before examination or treatment
-
Patients with mental retardation and dementia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Red de Salud de Ladera E.S.E. Servicio de Odontología | Cali | Valle | Colombia | |
| 2 | Universidad del Valle, Facultad de Salud, Escuela de Odontología | Cali | Valle | Colombia |
Sponsors and Collaborators
- Universidad del Valle, Colombia
Investigators
- Principal Investigator: Adolfo Contreras, DDS, MS, PhD, Universidad del Valle
- Principal Investigator: Jorge H Ramirez, MD, MS, Universidad del Valle
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jorge Hernán Ramírez,
principal investigator,
Universidad del Valle, Colombia
ClinicalTrials.gov Identifier:
NCT00681564
Other Study ID Numbers:
- COLCIENCIAS 110634319239
First Posted:
May 21, 2008
Last Update Posted:
Apr 17, 2014
Last Verified:
Mar 1, 2014
Keywords provided by Jorge Hernán Ramírez,
principal investigator,
Universidad del Valle, Colombia
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | rom April 2008 to March 2011 three hundred and six subjects were assessed for eligibility to participate in this randomized clinical trial. One hundred and two patients were randomized to the control (n=55) and treatment group (n=47). At 12 weeks of follow-up, 47 patients (control group) and 41 patients (treatment group) completed the study. |
|---|---|
| Pre-assignment Detail | Two hundred and four patients were excluded from this study for the following reasons: no fulfillment of inclusion criteria (n=183), refusal to participate (n=4), not assistance to study appointments (n=15), and another reasons (n=2). |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Period Title: Overall Study | ||
| STARTED | 47 | 55 |
| COMPLETED | 41 | 47 |
| NOT COMPLETED | 6 | 8 |
Baseline Characteristics
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) | Total |
|---|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal | Total of all reporting groups |
| Overall Participants | 47 | 55 | 102 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
45.5
(9.4)
|
45.5
(8.1)
|
45.5
(6.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
24
51.1%
|
30
54.5%
|
54
52.9%
|
| Male |
23
48.9%
|
25
45.5%
|
48
47.1%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| White |
6
12.8%
|
5
9.1%
|
11
10.8%
|
| Black |
5
10.6%
|
5
9.1%
|
10
9.8%
|
| Indian |
0
0%
|
3
5.5%
|
3
2.9%
|
| Mixed ethnicity |
36
76.6%
|
42
76.4%
|
78
76.5%
|
| Smoking status (participants) [Number] | |||
| Currently smoking |
12
25.5%
|
14
25.5%
|
26
25.5%
|
| Never smoker |
24
51.1%
|
28
50.9%
|
52
51%
|
| Former smoker |
11
23.4%
|
13
23.6%
|
24
23.5%
|
| Formal education (participants) [Number] | |||
| Elementary education (1 to 5 years) |
14
29.8%
|
17
30.9%
|
31
30.4%
|
| Secondary education (6 to 11 years) |
22
46.8%
|
25
45.5%
|
47
46.1%
|
| Higher education (12 or more years) |
11
23.4%
|
13
23.6%
|
24
23.5%
|
| Family monthly income (participants) [Number] | |||
| Less than $300 USD |
19
40.4%
|
23
41.8%
|
42
41.2%
|
| ≥ $300 and ≤ $600 USD |
24
51.1%
|
22
40%
|
46
45.1%
|
| More than $600 USD |
4
8.5%
|
10
18.2%
|
14
13.7%
|
| Medical insurance (participants) [Number] | |||
| None |
5
10.6%
|
5
9.1%
|
10
9.8%
|
| State-subsidized healthcare |
30
63.8%
|
34
61.8%
|
64
62.7%
|
| Contributory regime (private insurance) |
11
23.4%
|
15
27.3%
|
26
25.5%
|
| Prepaid medicine plan |
1
2.1%
|
1
1.8%
|
2
2%
|
| Endothelium-dependent brachial artery flow-mediated dilatation (Percentage of dilation) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Percentage of dilation] |
9.9
(7.4)
|
9.9
(8.5)
|
9.9
(7.9)
|
| Serum C-reactive protein (CRP) (mg/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/L] |
4
(7)
|
3.1
(3.6)
|
3.6
(5.4)
|
Outcome Measures
| Title | Brachial Artery Flow-mediated Dilation |
|---|---|
| Description | All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%). |
| Time Frame | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary outcome (difference on endothelium-dependent brachial artery FMD at baseline and three months after randomization) and the secondary outcome (hs-CRP, glucose, blood lipid profile and cardiovascular biomarkers) were analyzed using kruskal-wallis and unpaired t test depending on the distribution of the variables. |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 41 | 46 |
| Baseline |
10.2
(7.3)
|
10.3
(8.7)
|
| 24 hours |
13.1
(9.5)
|
8.1
(7.8)
|
| 12 weeks |
11.2
(9.7)
|
9.7
(8.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Periodontal Intervention (Experimental), Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Comments | Analyzed variable: Brachial Artery Flow-mediated Dilation (baseline). Note: data analysis of patients who completed the study protocol (n=86). Intention-to-treat analysis analysis was not used because its application for the evaluation of continuous data would imply imputing missing data for patients lost to follow-up. Mean and standard deviation of flow-mediated dilatation, including data from all patients randomized in this study, is reported in the field of baseline characteristics. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | A P value of 0.05 was used as a cut-off for statistical significance. | |
| Method | Kruskal-Wallis | |
| Comments | Non-parametric test appropriate for the analysis of non-normally distributed data. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Periodontal Intervention (Experimental), Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Comments | Analyzed variable: Brachial Artery Flow-mediated Dilation (24 hours). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | A P value of 0.05 was used as a cut-off for statistical significance. | |
| Method | Kruskal-Wallis | |
| Comments | Non-parametric test appropriate for the analysis of non-normally distributed data. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Periodontal Intervention (Experimental), Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Comments | Statistical analysis: Brachial Artery Flow-mediated Dilation (12 weeks). Intention-to-treat analysis was not used because input of values for patients lost at follow-up will artificially amplify the precision of outcome measures. Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1. The Cochrane Collaboration, 2008. www.cochrane-handbook.org. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.43 |
| Comments | A P value of 0.05 was used as a cut-off for statistical significance. | |
| Method | Kruskal-Wallis | |
| Comments | Non-parametric test appropriate for the analysis of non-normally distributed data. | |
| Title | High-sensitivity C-Reactive Protein |
|---|---|
| Description | The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens). |
| Time Frame | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 38 | 46 |
| Baseline |
4.2
(7.5)
|
3.1
(3.7)
|
| 24 hours |
4.9
(6.7)
|
4.1
(4.6)
|
| 12 weeks |
3.3
(4.9)
|
3.2
(3.8)
|
| Title | Total Cholesterol |
|---|---|
| Description | |
| Time Frame | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 40 | 46 |
| Baseline |
197
(38.7)
|
192.4
(33.8)
|
| 24 hours |
195.4
(40.9)
|
186.9
(42.8)
|
| 12 weeks |
203.9
(35.6)
|
200.6
(39.5)
|
| Title | White Blood Cell Count |
|---|---|
| Description | |
| Time Frame | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 40 | 46 |
| Baseline |
6937
(2986)
|
6380
(1682)
|
| 24 hours |
6198
(2601)
|
6088
(2411)
|
| 12 weeks |
5464
(3160)
|
5382
(2963)
|
| Title | Subgingival Microbiota |
|---|---|
| Description | Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf). |
| Time Frame | 12 weeks post-periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 39 | 44 |
| Participants positive for Pg |
31
66%
|
42
76.4%
|
| Participants positive for Td |
31
66%
|
38
69.1%
|
| Participants positive for Tf |
34
72.3%
|
40
72.7%
|
| Participants positive for Pg, Tf and Td |
25
53.2%
|
37
67.3%
|
| Title | LDL Cholesterol |
|---|---|
| Description | |
| Time Frame | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 40 | 46 |
| Baseline |
113.1
(37.6)
|
106.4
(32.8)
|
| 24 hours |
111.3
(41.3)
|
104.6
(33.9)
|
| 12 weeks |
119.9
(38.8)
|
109.5
(42.8)
|
| Title | Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin) |
|---|---|
| Description | Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®). Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis. |
| Time Frame | 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 38 | 46 |
| Mean (Standard Deviation) [ng/ml] |
44.8
(28.7)
|
42.9
(22.2)
|
| Title | Intercellular Adhesion Molecule 1 (ICAM-1) |
|---|---|
| Description | |
| Time Frame | 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 38 | 46 |
| Mean (Standard Deviation) [ng/ml] |
247.1
(196.7)
|
235.4
(229.6)
|
| Title | Vascular Cell Adhesion Molecule 1 (VCAM-1) |
|---|---|
| Description | |
| Time Frame | 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 38 | 46 |
| Mean (Standard Deviation) [ng/ml] |
1601.6
(372.4)
|
1588.1
(412.3)
|
| Title | Myeloperoxidase (MPO) |
|---|---|
| Description | |
| Time Frame | 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 38 | 46 |
| Mean (Standard Deviation) [ng/ml] |
62.6
(60.9)
|
83.8
(140.4)
|
| Title | Matrix Metalloproteinase-9 (MMP-9) |
|---|---|
| Description | |
| Time Frame | 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 38 | 46 |
| Mean (Standard Deviation) [ng/ml] |
103.4
(58.5)
|
110.5
(68.2)
|
| Title | Tissue Plasminogen Activator Inhibitor-1 (tPAI-1) |
|---|---|
| Description | |
| Time Frame | 12 weeks post periodontal therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. |
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Measure Participants | 38 | 46 |
| Mean (Standard Deviation) [ng/ml] |
116.1
(74.1)
|
110.7
(66.4)
|
Adverse Events
| Time Frame | One day after periodontal therapy | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Method for data collection: semi-structured interview and examination of periodontal tissues. | |||
| Arm/Group Title | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) | ||
| Arm/Group Description | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal | ||
All Cause Mortality |
||||
| Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/47 (0%) | 1/55 (1.8%) | ||
| Social circumstances | ||||
| Motor vehicle traffic accident | 0/47 (0%) | 0 | 1/55 (1.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 47/47 (100%) | 31/55 (56.4%) | ||
| Surgical and medical procedures | ||||
| Swelling | 47/47 (100%) | 28/55 (50.9%) | ||
| Gingival erythema or bleeding | 46/47 (97.9%) | 24/55 (43.6%) | ||
| Periodontal pain (low-intensity) | 36/47 (76.6%) | 18/55 (32.7%) | ||
Limitations/Caveats
1. Patient recruitment take more time that previously expected, 2. Longer time than expected for the standardization for laboratory techniques, 3. Changes of the study personnel during patient recruitment and laboratory analysis of biological samples
More Information
Certain Agreements
Principal Investigators are NOT 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 | Jorge Hernán Ramírez and Adolfo Contreras (adolfo@yahoo.com). |
|---|---|
| Organization | Universidad del Valle |
| Phone | 5723753778 |
| jorge.h.ramirez00@gmail.com |
Responsible Party:
Jorge Hernán Ramírez,
principal investigator,
Universidad del Valle, Colombia
ClinicalTrials.gov Identifier:
NCT00681564
Other Study ID Numbers:
- COLCIENCIAS 110634319239
First Posted:
May 21, 2008
Last Update Posted:
Apr 17, 2014
Last Verified:
Mar 1, 2014