Evaluation of Toothbrush Bristles in Plaque Reduction

NCT04681885 | Completed Results FDA Device

• 1 other identifier: CLP-2020-06-01-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods. 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.

Conditions

Plaque, Dental; Gingivitis

Outcome Measures

Primary Outcomes (2)

• Change of Navy Plaque Index (Navy Pl) After One-time Brushing

  Change of Navy Plaque Index (Navy Pl) after one-time brushing in a whole mouth. The Navy Plaque Index (PI) can be either 0 (plaque is not present) or 1 (plaque is present). Each tooth is partitioned into 9 areas, and the PI is evaluated for teeth numbered 2-15 and 18-31, totaling 28 teeth. Both buccal (B) and lingual (L) sides of each tooth are assessed. The PI value of each person ranges from 0 to 504 (28 teeth × 9 areas × 2 sides). Baseline value is calculated by averaging PI values of 10 subjects before brushing. Post-brushing value is calculated by averaging PI values of 10 subjects after a one-time brushing for 2 minutes

  Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline

• Change of Digitally Measured Interdental Plaque Area After One-time Brushing

  Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after one-time brushing by image analysis.

  Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline

Secondary Outcomes (2)

• Change of Navy Plaque Index (Navy PI) After 7-day Brushing

  Pre-intervention at baseline and after 7- day brushing at baseline

• Change of Digitally Measured Interdental Plaque Area After 7-day Brushing

  Pre-intervention at baseline and after 7-day brushing at baseline

Study Arms (3)

Tapered bristles A

EXPERIMENTAL

Test toothbrush with tapered bristle

Device: Tapered bristles A; Device: Tapered bristles B; Device: End rounded bristles

Tapered bristles B

ACTIVE COMPARATOR

Test toothbrush with tapered bristle

Device: Tapered bristles A; Device: Tapered bristles B; Device: End rounded bristles

End rounded bristles

ACTIVE COMPARATOR

Conventionla toothbrush with end rounded bristle

Device: Tapered bristles A; Device: Tapered bristles B; Device: End rounded bristles

Interventions

Tapered bristles A DEVICE

Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .

End rounded bristles; Tapered bristles A; Tapered bristles B

Tapered bristles B DEVICE

Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.

End rounded bristles; Tapered bristles A; Tapered bristles B

End rounded bristles DEVICE

Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.

End rounded bristles; Tapered bristles A; Tapered bristles B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunstar Americas: lead

Study Sites (1)

The University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Limitations and Caveats

Plaque area is not measured by image analysis due to: 1. The plaque area is so small as area% in a total region of interest. 2. Most of plaque on teeth surface of buccal side was removed after 2-minute brushing in most of subjects, so it is difficult to detect their difference. 3. Quality of accumulated plaque, e.g. thick but shallow area vs. thin but broad area, is hard to do the assessment. 4. Some photos were not appropriate for image analysis due to being a little out of focus.

Results Point of Contact

• Title: Toru Saito
• Organization: Sunstar Americas, Inc.

toru.saito@us.sunstar.com

1-847-794-4271

Study Officials

• Franklin Garcia-Godoy, DDS, PhD

  The University of Tennessee Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: June 30, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-07

Locations

US (1)