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

NCT03502538 | Completed

• 1 other identifier: CURAPROX5460-INDICATORPLUS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tooth Caries; Dental Plaque

Outcome Measures

Primary Outcomes (1)

• 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.

  Five months

Study Arms (2)

Curaprox 5460 Ultra Soft

EXPERIMENTAL

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

Device: Curaprox 5460 Ultra Soft; Device: Oral-B Indicator Plus

Oral-B Indicator Plus

ACTIVE COMPARATOR

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

Device: Curaprox 5460 Ultra Soft; Device: Oral-B Indicator Plus

Interventions

Curaprox 5460 Ultra Soft DEVICE

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.

Curaprox 5460 Ultra Soft; Oral-B Indicator Plus

Oral-B Indicator Plus DEVICE

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.

Curaprox 5460 Ultra Soft; Oral-B Indicator Plus

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good oral health
• At least, 24 health teeth

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Brasilia: lead

MeSH Terms

Conditions

Dental Caries; Dental Plaque

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Deposits

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a study designed where all the participants will have to try the two devices that were being tested.

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: April 18, 2018
• Study Start: June 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available when the journal accept the paper for publication.
• Access Criteria: The results will be provided by statistical analysis.