Skip to main content
OpenTrials
Completed

NCT Number: NCT04681885

Evaluation of Toothbrush Bristles in Plaque Reduction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plaque, Dental Dental Deposits Dental Plaque Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

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 .

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

Device

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

Primary outcomes

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

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

    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

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

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

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

Secondary outcomes

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

    Time frame: Pre-intervention at baseline and after 7- day brushing at baseline

    Change of Navy Plaque Index (Navy Pl) after 7-day 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. 7-day value is calculated by averaging PI values of 10 subjects after 7-day brushing.

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

    Time frame: Pre-intervention at baseline and after 7-day brushing at baseline

    Change of digitally measured interdental plaque area on non-molar teeth, facial/buccal aspect after 7- day brushing by image analysis.

Sponsors and collaborators

Lead sponsor

Sunstar Americas

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.