Evaluation of Toothbrush Bristles in Reduction of Plaque, Inflammation, Bleeding, and Abrasion: A Comparative Study of Tapered vs. End-Rounded Bristles
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Rustogi Modified Navy Plaque Index
Overview
Brief Summary
The goal of this randomized clinical trial is to investigate two different types of toothbrush bristles.
The main questions it aims to answer are the effects of two different bristle types on:
- how much plaque is on the teeth
- how deep the space is between gums and teeth
- how much gum and bone are attached to the teeth
- whether the gums bleed when checked
- if the gums get scratched or irritated
Researchers will compare toothbrushes with tapered bristles to those with regular round bristles.
Participants will be randomly assigned toothbrush A or B to use at home during the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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, not including implants.
- •Must have average Plaque Index of greater than 2 at screening.
- •Must have more than 20% of pockets with bleeding on probing at screening.
- •Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures 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
- •Physical limitations or restrictions that might preclude normal tooth brushing.
- •Evidence of gross oral pathology
- •Periodontal probing pocket depths (PPD) ≥ 5mm.
- •Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the 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
Arms & Interventions
Product A
Product A: Double Tapered J-hook bristles (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)
Intervention: Toothbrush with tapered bristles (Other)
Product B
End rounded bristles: (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)
Intervention: Toothbrush with end-rounded bristles (Other)
Outcomes
Primary Outcomes
Rustogi Modified Navy Plaque Index
Time Frame: Baseline, Week 2 and Week 4
Measured before and after on-site brushing to compare the frequency of plaque presence before and after brushing, as well as cumulative effects of brushing over 2 and 4 weeks. Plaque index is recorded as "1", meaning plaque is present or "0", meaning no plaque is present.
Secondary Outcomes
- Gingival Abrasion Score(Baseline, Week 2, and Week 4)
Investigators
Marcelle Nascimento
Assistant Dean for Clinical Research
State University of New York at Buffalo