Clinical trial NCT04681885: Evaluation of Toothbrush Bristles in Plaque Reduction
Official title: Evaluation of Toothbrush Bristles in Plaque Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque, Dental
Gingivitis
Lead sponsor: Sunstar Americas
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Navy Plaque Index (Navy Pl) After One-time Brushing
timeFrame: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
measure: Change of Digitally Measured Interdental Plaque Area After One-time Brushing
timeFrame: Pre-intervention at baseline and after one-time brushing for 2 minutes at baseline
Secondary outcomes:
measure: Change of Navy Plaque Index (Navy PI) After 7-day Brushing
timeFrame: Pre-intervention at baseline and after 7- day brushing at baseline
measure: Change of Digitally Measured Interdental Plaque Area After 7-day Brushing
timeFrame: Pre-intervention at baseline and after 7-day brushing at baseline
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: The University of Tennessee Health Science Center
name: Franklin Garcia-Godoy, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: