Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)
NCT ID: NCT05782348
Last Updated: 2025-04-29
Study Results
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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COMPLETED
NA
150 participants
INTERVENTIONAL
2023-08-06
2025-02-28
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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)
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.
Colgate smart toothbrush
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
Colgate smart toothbrush
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
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.
Colgate smart toothbrush
A Colgate smart toothbrush that provides the user with details on toothbrushing habits and frequency
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
14 Years
17 Years
ALL
Yes
Sponsors
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Temple University
OTHER
Howard University
OTHER
Responsible Party
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Brian Laurence
Professor
Locations
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Friendship Public Charter School
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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CRO-2022-10-CBT-HU-US-BS
Identifier Type: -
Identifier Source: org_study_id
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