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

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

Detailed Description
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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.

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

Conditions
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Plaque, Gingivitis

Intervention / Treatment
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* Device: Group using manual toothbrush Curaprox 5460 Ultra Soft
* Device: Group using sonic toothbrush Edel White


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Toothbrush users<br>Group using manual toothbrush Curaprox 5460 Ultra Soft | Device: Group using manual toothbrush Curaprox 5460 Ultra Soft<br>* Manual toothbrush usage with Bass technique twice a day during 2 minutes<br>|
| Active Comparator: Sonic Toothbrush users<br>Group using sonic toothbrush Edel White | Device: Group using sonic toothbrush Edel White<br>* Sonic toothbrush usage twice a day during 2 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 6 months | 
| Community periodontal index | 0 = No periodontal disease; 1 = Bleeding on probing; 2 = Calculus with plaque seen or felt by probing. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque, oral hygiene, gingivitis, sonic toothbrush, manual toothbrush