Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control

Phase 4

• Conditions: Gingivitis; Plaque
• Interventions: Device: Group using sonic toothbrush Edel White; Device: Group using manual toothbrush Curaprox 5460 Ultra Soft

• Registration Number: NCT03099551
• Lead Sponsor: Faculty Sao Leopoldo Mandic Campinas

Brief Summary

The aim of the present study was to evaluate the efficacy of two different toothbrushes (manual and sonic) on plaque control

Detailed Description

A parallel randomized clinical trial, examiner-blind, was conducted involving 56 patients with ages from 15 to 20, all students of CAMP (Centro de Formação e Integração Social), in the city of São Bernardo do Campo, state of São Paulo, Brazil. Randomization: the subjects were randomly allocated to two different groups (A for the manual toothbrush and B for the sonic toothbrush) by removing from an urn a paper with their respective group. Silness \& Löe Gingival Index, the Turesky Modification of the Quigley Hein Plaque Index and the Community Periodontal Index were evaluated at baseline and after 3 and 6 months.

Study Timeline

• Study Start: 2016-12
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Study First Posted: 2017-04-04
• Last Update Posted: 2017-04-04
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Subjects had to be in generally good health, and possessing a minimum of 20 permanent natural teeth, excluding third molars.

Exclusion Criteria

• Subjects were excluded if they had fixed orthodontic appliances, advanced periodontal disease, limited manual dexterity, active caries, medical conditions limiting their salivary function or immunological condition, and if they were smokers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sonic Toothbrush users	Group using sonic toothbrush Edel White	Group using sonic toothbrush Edel White
Manual Toothbrush users	Group using manual toothbrush Curaprox 5460 Ultra Soft	Group using manual toothbrush Curaprox 5460 Ultra Soft

Primary Outcome Measures

Name	Time	Method
Community periodontal index	6 months	0 = No periodontal disease; 1 = Bleeding on probing; 2 = Calculus with plaque seen or felt by probing.
Silness & Löe Gingival Index	6 months	0 = Normal gingiva; 1 = Mild inflammation - slight change in colour, slight oedema. No bleeding on probing; 2 = Moderate inflammation - redness, oedema and glazing; bleeding on probing; 3 = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding
Turesky Modification of the Quigley Hein Plaque Index	6 months	0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth; 3 = A band of plaque wider than one mm but covering less than one third of the crown of the tooth; 4 = Plaque covering at least one-third but less than two-thirds of the crown of the tooth; 5 = Plaque covering two-thirds or more of the crown of the tooth