Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

Not Applicable

Completed

• Conditions: Dental Plaque; Adolescent Behavior; Gingivitis; Cognitive Change
• Interventions: Behavioral: Cognitive behavioral intervention; Other: Colgate smart toothbrush

• Registration Number: NCT05782348
• Lead Sponsor: Howard University

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 Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-23
• Study Start: 2023-08-06
• Primary Completion: 2024-04-06
• Study Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group I	Colgate smart toothbrush	A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI)
Control group I	Colgate smart toothbrush	A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush
Test Group I	Cognitive behavioral intervention	A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI)

Primary Outcome Measures

Name	Time	Method
Gingival inflammation	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 Outcome Measures

Name	Time	Method
Knowledge assessment	All outcomes will be measured at baseline, 1 month, 3 months and at 6 months	Knowledge will be assessed using 19 item scale previously used by the researchers; Enrolled subjects will complete a questionnaire on oral health knowledge, attitudes, and practices including: frequency of brushing and flossing, knowledge, oral health values scale, self-efficacy and motivation. The outcome will be assessed using a 19-item multiple choice survey previously used in Colgate-sponsored research protocols. A six-item oral health self-efficacy scale will be used to measure participant self-reported confidence in their ability to carry out an oral health care routine. Lastly, motivation to engage in recommended oral hygiene behavior will be assessed with a single item 1analog scale (i.e., "How important is it to follow guidelines for brushing twice per day and flossing once per day, from 0 "not important at all" to 10 "most important.")
Motivation assessment	All outcomes will be measured at baseline, 1 month, 3months and at 6 months	Motivation will be assessed using a single item 10-point visual analog scale
Plaque scores	All outcomes will be measured at baseline, 1 month, 3 months and at 6 months	Mean plaque index scores will be computed for each subject. Each tooth is scored in six areas: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Whole mouth within subject mean scores will be computed as follows: Total plaque score for all scoring sites divided by total number of scoring sites
Efficacy assessment	All outcomes will be measured at baseline, 1 month, 3months and at 6 months	Efficacy will be assessed using a validated 6 item oral health self-efficacy scale

Trial Locations

Locations (1)

Friendship Public Charter School; 🇺🇸 Washington, District of Columbia, United States