Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

NCT05782348 | Completed

• 1 other identifier: CRO-2022-10-CBT-HU-US-BS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Behavior; Dental Plaque; Gingivitis; Cognitive Change

Keywords

adolescent health; dental plaque; gingivitis; cognitive change

Outcome Measures

Primary Outcomes (1)

• Gingival inflammation

  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 Outcomes (4)

• Plaque scores

  All outcomes will be measured at baseline, 1 month, 3 months and at 6 months

• Knowledge assessment

  All outcomes will be measured at baseline, 1 month, 3 months and at 6 months

• Efficacy assessment

  All outcomes will be measured at baseline, 1 month, 3months and at 6 months

• Motivation assessment

  All outcomes will be measured at baseline, 1 month, 3months and at 6 months

Study Arms (3)

Test Group I

EXPERIMENTAL

A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI)

Behavioral: Cognitive behavioral intervention; Other: Colgate smart toothbrush

Control group I

ACTIVE COMPARATOR

A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush

Other: Colgate smart toothbrush

Control group II

NO INTERVENTION

A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush

Interventions

Cognitive behavioral intervention BEHAVIORAL

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.

Test Group I

Colgate smart toothbrush OTHER

A Colgate smart toothbrush that provides the user with details on toothbrushing habits and frequency

Control group I; Test Group I

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Howard University: lead
• Temple University: collaborator

Study Sites (1)

Friendship Public Charter School

Washington D.C., District of Columbia, 20059, United States

Location

MeSH Terms

Conditions

Adolescent Behavior; Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three arm parallel group single blind study

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 23, 2023
• Study Start: August 6, 2023
• Primary Completion: April 6, 2024
• Study Completion: February 28, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)