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NCT04681885 · ClinicalTrials.gov registry record · NA
Evaluation of Toothbrush Bristles in Plaque Reduction
A NA study of Gingivitis and Plaque, Dental, sponsored by Sunstar Americas.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04681885: Completed NA study of Gingivitis and Plaque, Dental, sponsored by Sunstar Americas.
NCT04681885 is a NA study of Gingivitis and Plaque, Dental that has completed, run by Sunstar Americas. The registered enrollment target is 10 participants, below the 236-participant average among 25 other Gingivitis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04681885, a NA study of Gingivitis and Plaque, Dental, has completed, sponsored by Sunstar Americas.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change of Navy Plaque Index (Navy Pl) after one-time brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subj
Conditions Studied
Interventions
- DEVICE Tapered bristles A
- DEVICE Tapered bristles B
- DEVICE End rounded bristles
Study Locations (1)
Tennessee
- The University of Tennessee Health Science Center - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2021-09-17 |
| Phase | NA |
What the finished NCT04681885 record still lists
NCT04681885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 236-participant average among 25 other Gingivitis trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Gingivitis appearing as the primary indexed condition, and to 3 interventions - of which Tapered bristles A is the first listed.
NCT04681885 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04681885 about?
NCT04681885 is a clinical study titled "Evaluation of Toothbrush Bristles in Plaque Reduction". 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...
What is the current status of trial NCT04681885?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2021-06-30. Estimated completion is 2021-09-17.
What conditions does trial NCT04681885 study?
This clinical trial studies the following conditions: Gingivitis, Plaque, Dental.
What interventions are being tested in trial NCT04681885?
The interventions under investigation include: Tapered bristles A (DEVICE), Tapered bristles B (DEVICE), End rounded bristles (DEVICE).
Who is sponsoring clinical trial NCT04681885?
This trial is sponsored by Sunstar Americas, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04681885 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04681885's enrollment target sits among peer trials
10 25th of 25 higher than 1 of 25 other Gingivitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gingivitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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