Clinical Study to Evaluate the Effectiveness of a Cognitive Behavioral Intervention (CBI) Adjunctive to a Smart Powered Toothbrush on the Oral Health of Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Howard University
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Gingival inflammation
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None (Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Gingival inflammation
Time Frame: All outcomes will be measured at baseline, at1 month, 3 months and at 6 months
A Löe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored. Scores Criteria 0 Absence of inflammation 1. Mild inflammation- Slight change in color and mild edema with little change in texture. No bleeding on probing. 2. Moderate inflammation- moderate glazing, redness, edema and hypertrophy. Bleeding on probing. 3. Severe inflammation- Marked redness, hypertrophy, edema and ulceration. Tendency for spontaneous bleeding.
Secondary Outcomes
- Knowledge assessment(All outcomes will be measured at baseline, 1 month, 3 months and at 6 months)
- Motivation assessment(All outcomes will be measured at baseline, 1 month, 3months and at 6 months)
- Plaque scores(All outcomes will be measured at baseline, 1 month, 3 months and at 6 months)
- Efficacy assessment(All outcomes will be measured at baseline, 1 month, 3months and at 6 months)
Investigators
Brian Laurence
Professor
Howard University