Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

Last updated: April 25, 2025
Sponsor: Howard University
Overall Status: Completed

Phase

N/A

Condition

Periodontitis

Treatment

Cognitive behavioral intervention

Colgate smart toothbrush

Clinical Study ID

NCT05782348
CRO-2022-10-CBT-HU-US-BS
  • Ages 14-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a Phase III, randomized, one-center, three arm parallel group, open label and single blind clinical study to evaluate the effectiveness of a cognitive behavioral intervention (CBI) adjunctive to a smart powered toothbrush on the oral health of adolescents.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Students are enrolled in participating high schools Caregivers give informed consent Student gives assent

Exclusion

Exclusion Criteria:

  • Having a prosthetic heart valve

  • Having a history of previously having infective endocarditis

  • Having had joint replacement surgery

  • Children on blood thinner medication such as Coumadin or Rivaroxaban

  • Children who are currently receiving chemotherapy

  • Children who have received organ transplants of any type

  • Children with Leukemia

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Cognitive behavioral intervention
Phase:
Study Start date:
August 06, 2023
Estimated Completion Date:
February 28, 2025

Study Description

This is a Phase III, randomized, one-center, three arm parallel group, open label and single blind clinical study to evaluate the effectiveness of a cognitive behavioral intervention (CBI) adjunctive to a smart powered toothbrush on the oral health of adolescents. Outcomes briefly summarized include the plaque score, gingival score and a survey of knowledge, attitudes and procedures measured at 1,3 and 6 months

Participating subjects will be randomized to one of the following products:

TEST GROUP I A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush CONTROL GROUP I A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush CONTROL GROUP II A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush

Connect with a study center

  • Friendship Public Charter School

    Washington, District of Columbia 20059
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.