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A Comparative Study of the Efficacy in Plaque Removal of Two Manual Toothbrushes

Primary Purpose

Tooth Caries, Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Curaprox 5460 Ultra Soft
Oral-B Indicator Plus
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tooth Caries

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Good oral health
  • At least, 24 health teeth

Exclusion Criteria:

  • Those with any limitations that make it difficult for the dental examination or the performance of brushing, which use removable prostheses, orthodontic appliances, and/or that have malocclusions, and the presence of a gingival recess equal to or greater than 2mm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Curaprox 5460 Ultra Soft

    Oral-B Indicator Plus

    Arm Description

    Brushing with a Curaprox Ultra Soft 5460 toothbrush for one minute timed without orientations about brushing techniques and without supervision

    Brushing with a Oral-B Indicator Plus toothbrush for one minute timed without orientations about brushing techniques and without supervision

    Outcomes

    Primary Outcome Measures

    Comparison of dental plaque removal between the toothbrushes Curaprox and Oral-B
    The participants should stay for 24 hours without toothbrushing. After that, their dental surfaces will be stained, evaluated and the amount of dental plaque will be recorded. The first recording of the dental plaque will be registered and the brushing with each toothbrush model (at two different times, being these at least one week apart) was performed. Then, a second registration will be recorded. The measurement will be perfomed by visual assessment, according to the Plaque Index mentioned before. The index is based on the assessment of six areas of the dental surface; three in the buccal surface (mesio, middle and distobuccal) and three on the palatine / lingual surface following the same order (mesio, medium and disto). For each area a value according to the presence of plaque will be recorded. These values can be from 0 to 5. A statistical analysis will be performed to compare the amount of plaque removing after brushing with each toothbrush model.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 29, 2017
    Last Updated
    April 10, 2018
    Sponsor
    University of Brasilia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03502538
    Brief Title
    A Comparative Study of the Efficacy in Plaque Removal of Two Manual Toothbrushes
    Official Title
    A Comparative Study of the Efficacy in Plaque Removal of Two Manual Toothbrushes Models: Curaprox® CS 5460 Ultra Soft and Oral-B® Indicator Plus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Brasilia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective: To compare the efficacy of Curaprox® CS 5460 Ultra Soft and Oral-B® Indicator Plus toothbrushes in dental plaque removal. Methods: 50 adult participants will be included in the sample. For a period of 24 hours (at two different times), they will be instructed to stop oral hygiene. During the final 4 hours, the interruption of consumption of foods and liquids will be recommended, and in smokers' case, the use of cigarettes. In two clinical visits (T0 and T1), volunteers will be asked to brush their teeth for 1 minute with Curaprox® (CS 5460 Ultra Soft) e Oral-B® (Indicator Plus) toothbrushes. Disclosure will be performed prior to and after brushing and the presence of plaque on the tooth surfaces will be evaluated. Turesky Modified Quigley Hein Plaque Index will be used for the plaque record. For statistical analysis, paired t tests will be performed to compare the effectiveness of toothbrushes and correlation test to assess whether the fact that the patient was aware of the toothbrush that will be used influenced in their performance.
    Detailed Description
    For the study, 50 patients, between 18 and 55 years of age, of both sexes and healthy will be selected. For the study performance, volunteers will be instructed to stop their brushing for 23 to 25 hours before the first clinical visit. In addition, they will be also instructed to stop eating (solid foods and liquids) and to stop the use of cigarettes, if smoker, for 4 hours before evaluation. Prior to the study, a pilot study will be conducted at the University Hospital of Brasília for the researcher calibration using the Turesky Modified Quigley Hein Plaque Index, following the predetermined protocol. A double-blind crossover study will be designed in which each volunteer will test two different models of toothbrushes. Prior to the beginning of the study, the brushes handle will be hidden with tape in a way that it will be not possible to see the toothbrush trademark. During the two visits, both brushes will be placed on the workbench and in the absence of the researcher, the participant will select one of the brushes. In the following visit, the same procedure will be performed and the participant will use the second brush. A period of washout of at least one week between the the first visit and the second visit will be done to obtain non-interference between results. No brush restriction will be imposed for the participant during this period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Caries, Dental Plaque

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    This is a study designed where all the participants will have to try the two devices that were being tested.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Curaprox 5460 Ultra Soft
    Arm Type
    Experimental
    Arm Description
    Brushing with a Curaprox Ultra Soft 5460 toothbrush for one minute timed without orientations about brushing techniques and without supervision
    Arm Title
    Oral-B Indicator Plus
    Arm Type
    Active Comparator
    Arm Description
    Brushing with a Oral-B Indicator Plus toothbrush for one minute timed without orientations about brushing techniques and without supervision
    Intervention Type
    Device
    Intervention Name(s)
    Curaprox 5460 Ultra Soft
    Intervention Description
    The toothbrush Curaprox 5460 Ultra Soft will be the tested toothbrush model, in order to asses its efficacy in plaque removal. Therefore, the study participants should brush their teeth using this toothbrush model, following the instructions of the investigator. From the data collect related in plaque removal the results will be arrived at.
    Intervention Type
    Device
    Intervention Name(s)
    Oral-B Indicator Plus
    Intervention Description
    Following the same method of the Curaprox group intervention, the participants should brush their teeth using the Oral-B Indicator Plus toothbrush and based on the data collect, the results will be compared with the first group of intervention.
    Primary Outcome Measure Information:
    Title
    Comparison of dental plaque removal between the toothbrushes Curaprox and Oral-B
    Description
    The participants should stay for 24 hours without toothbrushing. After that, their dental surfaces will be stained, evaluated and the amount of dental plaque will be recorded. The first recording of the dental plaque will be registered and the brushing with each toothbrush model (at two different times, being these at least one week apart) was performed. Then, a second registration will be recorded. The measurement will be perfomed by visual assessment, according to the Plaque Index mentioned before. The index is based on the assessment of six areas of the dental surface; three in the buccal surface (mesio, middle and distobuccal) and three on the palatine / lingual surface following the same order (mesio, medium and disto). For each area a value according to the presence of plaque will be recorded. These values can be from 0 to 5. A statistical analysis will be performed to compare the amount of plaque removing after brushing with each toothbrush model.
    Time Frame
    Five months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Good oral health At least, 24 health teeth Exclusion Criteria: Those with any limitations that make it difficult for the dental examination or the performance of brushing, which use removable prostheses, orthodontic appliances, and/or that have malocclusions, and the presence of a gingival recess equal to or greater than 2mm

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The results will be published. Consent forms and participant information sheets will explain how data will be shared after the study.
    IPD Sharing Time Frame
    Data will be available when the journal accept the paper for publication.
    IPD Sharing Access Criteria
    The results will be provided by statistical analysis.

    Learn more about this trial

    A Comparative Study of the Efficacy in Plaque Removal of Two Manual Toothbrushes

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