CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Tapered bristles A +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04681885
NCT04681885N/ACompleted

Evaluation of Toothbrush Bristles in Plaque Reduction

Sunstar Americas·interventional·Posted Dec 23, 2020·Updated Oct 15, 2024

In Brief

A clinical study evaluating Tapered bristles A, Tapered bristles B, and 1 other intervention for Plaque, Dental and Gingivitis. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods. This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 23, 2020
Enrollment StartJun 30, 2021
Primary CompletionSep 17, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.5 years ago

Interventions

Tapered bristles Adevice

Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .

Tapered bristles Bdevice

Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.

End rounded bristlesdevice

Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.