Clinical trial NCT05782348: Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)
Official title: Clinical Study to Evaluate the Effectiveness of a Cognitive Behavioral Intervention (CBI) Adjunctive to a Smart Powered Toothbrush on the Oral Health of Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Dental Plaque
Gingivitis
Cognitive Change
Keywords: adolescent health
dental plaque
gingivitis
cognitive change
Lead sponsor: Howard University
Sponsor class: OTHER
Collaborators: name: Temple University
First posted: 2023-03-23
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arm parallel group single blind study
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Gingival inflammation
timeFrame: All outcomes will be measured at baseline, at1 month, 3 months and at 6 months
Secondary outcomes:
measure: Plaque scores
timeFrame: All outcomes will be measured at baseline, 1 month, 3 months and at 6 months
measure: Knowledge assessment
timeFrame: All outcomes will be measured at baseline, 1 month, 3 months and at 6 months
measure: Efficacy assessment
timeFrame: All outcomes will be measured at baseline, 1 month, 3months and at 6 months
measure: Motivation assessment
timeFrame: All outcomes will be measured at baseline, 1 month, 3months and at 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Friendship Public Charter School
state: District of Columbia
Study officials:
References: