Frequency of Self-performed Mechanical Control of Plaque

Not Applicable

• Conditions: Gingivitis; Oral Health
• Interventions: Behavioral: Frequency of mechanical control of plaque (12h); Behavioral: Frequency of mechanical control of plaque (24h); Behavioral: Frequency of mechanical control of plaque (48h)

• Registration Number: NCT02684682
• Lead Sponsor: Universidade Federal de Santa Maria

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-18
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-04-04
• Primary Completion: 2016-11
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12h Group	Frequency of mechanical control of plaque (12h)	Intervention 'Frequency of mechanical control of plaque (12h)'
24h Group	Frequency of mechanical control of plaque (24h)	Intervention 'Frequency of mechanical control of plaque (24h)'
48h Group	Frequency of mechanical control of plaque (48h)	Intervention 'Frequency of mechanical control of plaque (48h)'

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes from baseline plaque level at 30,60 and 90 days.	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.
Changes from volume of gingival fluid at 30,60 and 90 days.	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.

Trial Locations

Locations (1)

Juliana Maier; 🇧🇷 Santa Maria, RS, Brazil