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
About this trial
This is an interventional prevention trial for Tooth Caries
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
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
NCT ID
NCT03502538
First Posted
January 29, 2017
Last Updated
April 10, 2018
Sponsor
University of Brasilia
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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