Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2021-06-30
2021-09-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Toothbrush Bristles
NCT07306026
Efficacy of Manual Toothbrushes in Removing Dental Plaque
NCT04025684
Comparing the Inter-dental Brush to Dental Floss
NCT00743548
Clinical Safety and Efficacy Study of Water Flosser in Enhancing Oral Health Among Healthy Adults Having Plaque-induced Gingivitis and Dental Plaque Accumulation
NCT07204951
Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model
NCT06122376
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tapered bristles A
Test toothbrush with tapered bristle
Tapered bristles A
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .
Tapered bristles B
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
End rounded bristles
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Tapered bristles B
Test toothbrush with tapered bristle
Tapered bristles A
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .
Tapered bristles B
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
End rounded bristles
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
End rounded bristles
Conventionla toothbrush with end rounded bristle
Tapered bristles A
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .
Tapered bristles B
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
End rounded bristles
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tapered bristles A
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .
Tapered bristles B
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
End rounded bristles
Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be 18 to 70 years of age, male or female
* Have at least 20 natural or restored teeth
* Must have average Plaque Index of Ramfjord teeth at baseline greater than 2(Quigley and Hein) at screening
* Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study
* Agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the appointment in the study
* Agree to abstain from the use of any dental products other than those provided in the study
* Agree to comply with the conditions and schedule of the study
Exclusion Criteria
* Evidence of gross oral pathology
* Presence of severe gingivitis with 30 or more sites showing bleeding on probing
* Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner
* Chronic disease with concomitant oral manifestations
* Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months
* Currently using bleaching trays
* Eating disorders
* Recent history of substance abuse
* Smoking \>10 cigarettes/day
* Participation in other clinical studies within 14 days of screening
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sunstar Americas
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Franklin Garcia-Godoy, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Tennessee Health Science Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Tennessee Health Science Center
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLP-2020-06-01-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.