Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

Howard University

Status: Completed

Conditions: Dental Plaque; Cognitive Change; Adolescent Behavior; Gingivitis

Treatments: Other: Colgate smart toothbrush; Behavioral: Cognitive behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05782348

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

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 patients

Sex: All

Ages: 14 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Test Group I

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive behavioral intervention

Other: Colgate smart toothbrush

Control group I

Active Comparator group

Description:

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

Treatment:

Other: Colgate smart toothbrush

Control group II

No Intervention group

Description:

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