Evaluation of Toothbrush Bristles

University at Buffalo (UB)

Status: Enrolling

Conditions: Gingivitis and Periodontal Diseases

Treatments: Other: Toothbrush with tapered bristles; Other: Toothbrush with end-rounded bristles

Study type: Interventional

Funder types: Other

Identifiers

NCT07306026

STUDY00009358

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Product A

Other group

Description:

Product A: Double Tapered J-hook bristles (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)

Treatment:

Other: Toothbrush with tapered bristles

Product B

Other group

Description:

End rounded bristles: (GUM® Technique® Deep Clean Toothbrush, 525 TPA1)

Treatment:

Other: Toothbrush with end-rounded bristles