Frequency of Self-performed Mechanical Control of Plaque

Sponsor

Universidade Federal de Santa Maria (Other)

Overall Status

Unknown status

CT.gov ID

NCT02684682

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis Oral Health	Behavioral: Frequency of mechanical control of plaque (12h) Behavioral: Frequency of mechanical control of plaque (24h) Behavioral: Frequency of mechanical control of plaque (48h)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Official Title:

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

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Other: 12h Group

Intervention 'Frequency of mechanical control of plaque (12h)'

Behavioral: Frequency of mechanical control of plaque (12h)

Performing oral hygiene 12 in 12 hours, with tooth brush and interdental device.

Other: 24h Group

Intervention 'Frequency of mechanical control of plaque (24h)'

Behavioral: Frequency of mechanical control of plaque (24h)

Performing oral hygiene 24 in 24 hours, , with tooth brush and interdental device.

Other: 48h Group

Intervention 'Frequency of mechanical control of plaque (48h)'

Behavioral: Frequency of mechanical control of plaque (48h)

Performing oral hygiene 48 in 48 hours, , with tooth brush and interdental device.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.