Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

April 25, 2025 updated by: Brian Laurence, Howard University

Clinical Study to Evaluate the Effectiveness of a Cognitive Behavioral Intervention (CBI) Adjunctive to a Smart Powered Toothbrush on the Oral Health of Adolescents

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20059
        • Friendship Public Charter School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group I
A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI)
Behavioral: Cognitive behavioral intervention
A six-session CBI Intervention component will be used with the TEST GROUP I. This will examine a cognitive behavioral intervention designed to improve tooth brushing and oral hygiene. The components include oral health education, values-based activities, motivational interviewing, goal setting, problem solving skills, cognitive restructuring, verbal reinforcement and stress management.
Other: Colgate smart toothbrush
A Colgate smart toothbrush that provides the user with details on toothbrushing habits and frequency
Active Comparator: Control group I
A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush
Other: Colgate smart toothbrush
A Colgate smart toothbrush that provides the user with details on toothbrushing habits and frequency
No Intervention: Control group II
A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival inflammation
Time Frame: All outcomes will be measured at baseline, at1 month, 3 months and at 6 months

A Löe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored.

Scores Criteria 0 Absence of inflammation

  1. Mild inflammation- Slight change in color and mild edema with little change in texture. No bleeding on probing.
  2. Moderate inflammation- moderate glazing, redness, edema and hypertrophy. Bleeding on probing.
  3. Severe inflammation- Marked redness, hypertrophy, edema and ulceration. Tendency for spontaneous bleeding.
All outcomes will be measured at baseline, at1 month, 3 months and at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque scores
Time Frame: All outcomes will be measured at baseline, 1 month, 3 months and at 6 months

Mean plaque index scores will be computed for each subject. Each tooth is scored in six areas: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Whole mouth within subject mean scores will be computed as follows:

Total plaque score for all scoring sites divided by total number of scoring sites
All outcomes will be measured at baseline, 1 month, 3 months and at 6 months
Knowledge assessment
Time Frame: All outcomes will be measured at baseline, 1 month, 3 months and at 6 months

Knowledge will be assessed using 19 item scale previously used by the researchers

Enrolled subjects will complete a questionnaire on oral health knowledge, attitudes, and practices including: frequency of brushing and flossing, knowledge, oral health values scale, self-efficacy and motivation. The outcome will be assessed using a 19-item multiple choice survey previously used in Colgate-sponsored research protocols. A six-item oral health self-efficacy scale will be used to measure participant self-reported confidence in their ability to carry out an oral health care routine. Lastly, motivation to engage in recommended oral hygiene behavior will be assessed with a single item 1analog scale (i.e., "How important is it to follow guidelines for brushing twice per day and flossing once per day, from 0 "not important at all" to 10 "most important.")
All outcomes will be measured at baseline, 1 month, 3 months and at 6 months
Efficacy assessment
Time Frame: All outcomes will be measured at baseline, 1 month, 3months and at 6 months
Efficacy will be assessed using a validated 6 item oral health self-efficacy scale
All outcomes will be measured at baseline, 1 month, 3months and at 6 months
Motivation assessment
Time Frame: All outcomes will be measured at baseline, 1 month, 3months and at 6 months
Motivation will be assessed using a single item 10-point visual analog scale
All outcomes will be measured at baseline, 1 month, 3months and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Howard University

Collaborators

Temple University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2023

Primary Completion (Actual)

April 6, 2024

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2022-10-CBT-HU-US-BS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual data available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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