NCT05782348

Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Howard University · Academic / Other
• Sex: All
• Age: 14 Years – 17 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Adolescent Behavior
• Dental Plaque
• Gingivitis
• Cognitive Change

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-06
• Primary completion: 2024-04-06
• Completion: 2025-02-28
• First posted: 2023-03-23
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States