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

Primary Purpose

Plaque, Gingivitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Group using manual toothbrush Curaprox 5460 Ultra Soft
Group using sonic toothbrush Edel White
Sponsored by
Faculty Sao Leopoldo Mandic Campinas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Plaque focused on measuring Plaque, oral hygiene, gingivitis, sonic toothbrush, manual toothbrush

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Manual Toothbrush users

    Sonic Toothbrush users

    Arm Description

    Group using manual toothbrush Curaprox 5460 Ultra Soft

    Group using sonic toothbrush Edel White

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2017
    Last Updated
    March 31, 2017
    Sponsor
    Faculty Sao Leopoldo Mandic Campinas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03099551
    Brief Title
    Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control
    Official Title
    Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Faculty Sao Leopoldo Mandic Campinas

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plaque, Gingivitis
    Keywords
    Plaque, oral hygiene, gingivitis, sonic toothbrush, manual toothbrush

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Manual Toothbrush users
    Arm Type
    Active Comparator
    Arm Description
    Group using manual toothbrush Curaprox 5460 Ultra Soft
    Arm Title
    Sonic Toothbrush users
    Arm Type
    Active Comparator
    Arm Description
    Group using sonic toothbrush Edel White
    Intervention Type
    Device
    Intervention Name(s)
    Group using manual toothbrush Curaprox 5460 Ultra Soft
    Intervention Description
    Manual toothbrush usage with Bass technique twice a day during 2 minutes
    Intervention Type
    Device
    Intervention Name(s)
    Group using sonic toothbrush Edel White
    Intervention Description
    Sonic toothbrush usage twice a day during 2 minutes
    Primary Outcome Measure Information:
    Title
    Silness & Löe Gingival Index
    Description
    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
    Title
    Turesky Modification of the Quigley Hein Plaque Index
    Description
    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
    Title
    Community periodontal index
    Description
    0 = No periodontal disease; 1 = Bleeding on probing; 2 = Calculus with plaque seen or felt by probing.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control

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