Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

NCT ID: NCT05782348

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-06

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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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

Conditions

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Adolescent Behavior Dental Plaque Gingivitis Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three arm parallel group single blind study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Group I

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

Group Type EXPERIMENTAL

Cognitive behavioral intervention

Intervention Type 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.

Colgate smart toothbrush

Intervention Type OTHER

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

Control group I

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

Group Type ACTIVE_COMPARATOR

Colgate smart toothbrush

Intervention Type OTHER

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

Control group II

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Colgate smart toothbrush

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Temple University

OTHER

Sponsor Role collaborator

Howard University

OTHER

Sponsor Role lead

Responsible Party

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Brian Laurence

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Friendship Public Charter School

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

Site Status

Countries

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United States

Other Identifiers

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CRO-2022-10-CBT-HU-US-BS

Identifier Type: -

Identifier Source: org_study_id

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