Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control
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|ClinicalTrials.gov Identifier: NCT03099551|
Recruitment Status : Unknown
Verified March 2017 by Faculty Sao Leopoldo Mandic Campinas.
Recruitment status was: Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Faculty Sao Leopoldo Mandic Campinas
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Faculty Sao Leopoldo Mandic Campinas
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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
|Condition or disease||Intervention/treatment||Phase|
|Plaque Gingivitis||Device: Group using manual toothbrush Curaprox 5460 Ultra Soft Device: Group using sonic toothbrush Edel White||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||June 2017|
Active Comparator: Manual Toothbrush users
Group using manual toothbrush Curaprox 5460 Ultra Soft
Device: Group using manual toothbrush Curaprox 5460 Ultra Soft
Manual toothbrush usage with Bass technique twice a day during 2 minutes
Active Comparator: Sonic Toothbrush users
Group using sonic toothbrush Edel White
Device: Group using sonic toothbrush Edel White
Sonic toothbrush usage twice a day during 2 minutes
Primary Outcome Measures :
- Silness & Löe Gingival Index [ Time Frame: 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 [ Time Frame: 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
- Community periodontal index [ Time Frame: 6 months ]0 = No periodontal disease; 1 = Bleeding on probing; 2 = Calculus with plaque seen or felt by probing.
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|Ages Eligible for Study:||15 Years to 20 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Subjects had to be in generally good health, and possessing a minimum of 20 permanent natural teeth, excluding third molars.
- 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.
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|Responsible Party:||Faculty Sao Leopoldo Mandic Campinas|
|Other Study ID Numbers:||
|First Posted:||April 4, 2017 Key Record Dates|
|Last Update Posted:||April 4, 2017|
|Last Verified:||March 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Keywords provided by Faculty Sao Leopoldo Mandic Campinas:
Additional relevant MeSH terms: