Evaluation of Toothbrush Bristles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toothbrush with tapered bristles, Toothbrush with end-rounded bristles.
- Who it may be relevant to
- Registry conditions: Gingivitis and Periodontal Diseases. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Toothbrush Bristles in Reduction of Plaque, Inflammation, Bleeding, and Abrasion: A Comparative Study of Tapered vs. End-Rounded Bristles
Overview
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.
Interventions
- Other Toothbrush with tapered bristles
Toothbrush with tapered bristles - Other Toothbrush with end-rounded bristles
Toothbrush with end-rounded bristles
Primary outcome measures
- Rustogi Modified Navy Plaque Index [Time frame: Baseline, Week 2 and Week 4]
Secondary outcome measures (1)
- Gingival Abrasion Score [Time frame: Baseline, Week 2, and Week 4]
Eligibility criteria
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
- Participation in other clinical studies within 14 days of screening
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- SUNY Buffalo School of Dental Medicine — Buffalo
Identifiers
NCT: NCT07306026 · STUDY00009358