Status:
COMPLETED
Evaluation of Toothbrush Bristles in Plaque Reduction
Lead Sponsor:
Sunstar Americas
Conditions:
Plaque, Dental
Gingivitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 plaqu...
Eligibility Criteria
Inclusion
- Individuals may be included in the study if they meet all of the following inclusion criteria:
- Must have read, understood and signed an informed consent prior to being entered into the study
- 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
- Individuals are not eligible for participation in this study if any of the following are noted:
- Physical limitations or restrictions that might preclude normal tooth brushing
- 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
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04681885
Start Date
June 30 2021
End Date
September 17 2021
Last Update
October 15 2024
Active Locations (1)
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1
The University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163