Frequency of Self-performed Mechanical Control of Plaque

Study Overview
=================
Brief Summary
-----------------
The purpose of this blind randomized clinical trial is to evaluate different frequencies in self-mechanical control of plaque in individuals with historic of periodontitis and in periodic and preventive maintenance in order to assess which frequencies are compatible with maintaining gingival health.

Detailed Description
-----------------
Thirty nine subjects with at most 5% of the sites for GI= 2 (gingival health) will be randomized into three groups with different frequencies in self-mechanical control of plaque: Group 12 hours, 24 hours and 48 hours. The exams of plaque index, gingival index, probing depth, bleeding on probing, clinical attachment level and gingival crevicular fluid will be performed at baseline, 15, 30, 60 and 90 days.

Official Title
-----------------
Effect of Self-performed Mechanical Control of Plaque Frequency in Patients With Historic of Periodontitis and in Maintenance

Conditions
-----------------
Gingivitis, Oral Health

Intervention / Treatment
-----------------
* Behavioral: Frequency of mechanical control of plaque (12h)
* Behavioral: Frequency of mechanical control of plaque (24h)
* Behavioral: Frequency of mechanical control of plaque (48h)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with historic of periodontitis (loss of interproximal insertion ≥3mm in two or more non-adjacent teeth) treated in the Clinic of Postgraduate Periodontics at the Federal University of Santa Maria and included in the periodontal maintenance program; Minimum age of 35; Individuals with at least 12 teeth in the mouth; Maximum of 15% of sites with gingivitis; Maximum of 25% of sites with bleeding on probing. Exclusion Criteria: Smokers; Pregnant women; Individuals with dryness of the mouth (xerostomia); Diabetics; Psychomotor disturbances; Orthodontic equipment; Antimicrobial prophylaxis; Individuals using any medication associated with gingival overgrowth; Individuals that used antibiotic/anti -inflammatory in recent 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 12h Group<br>Intervention 'Frequency of mechanical control of plaque (12h)' | Behavioral: Frequency of mechanical control of plaque (12h)<br>* Performing oral hygiene 12 in 12 hours, with tooth brush and interdental device.<br>|
| Other: 24h Group<br>Intervention 'Frequency of mechanical control of plaque (24h)' | Behavioral: Frequency of mechanical control of plaque (24h)<br>* Performing oral hygiene 24 in 24 hours, , with tooth brush and interdental device.<br>|
| Other: 48h Group<br>Intervention 'Frequency of mechanical control of plaque (48h)' | Behavioral: Frequency of mechanical control of plaque (48h)<br>* Performing oral hygiene 48 in 48 hours, , with tooth brush and interdental device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline gingival index at 30, 60 and 90 days. | Assess how different frequencies of self-performed mechanical control of plaque interfere in gingival status. | 30,60 and 90 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline plaque level at 30,60 and 90 days. | Assess how different frequencies of self-performed mechanical control of plaque interfere in the accumulation of supragingival biofilm. Correlate changes in plaque levels with changes in gingival index. | 30,60 and 90 days. | 
| Changes from volume of gingival fluid at 30,60 and 90 days. | Assess how different frequencies of self-performed mechanical control of plaque interfere in the volume of gingival fluid. Correlate volume of gingival fluid with GI scores and bleeding on probing scores. | 30,60 and 90 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toothbrushing, Gingivitis, Dental Plaque, Periodontal Diseases, Clinical Trial