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

Faculty Sao Leopoldo Mandic Campinas56 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Plaque Gingivitis

Interventions

Group using manual toothbrush Curaprox 5460 Ultra SoftDEVICE

Manual toothbrush usage with Bass technique twice a day during 2 minutes

Group using sonic toothbrush Edel WhiteDEVICE

Sonic toothbrush usage twice a day during 2 minutes

Eligibility

Sex: ALLMin age: 15 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Silness & Löe Gingival Index

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

Time frame: 6 months

Turesky Modification of the Quigley Hein Plaque Index

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

Time frame: 6 months

Community periodontal index

0 = No periodontal disease; 1 = Bleeding on probing; 2 = Calculus with plaque seen or felt by probing.

Time frame: 6 months

Data from ClinicalTrials.gov

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