Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

Gingivitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782348
• Other study ID #: CRO-2022-10-CBT-HU-US-BS
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Howard University
• Contact: Brian Laurence, PhD
• Phone: 5713090308
• Email: blaurence[@]howard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Cognitive Change
• Dental Plaque
• Gingivitis

Intervention

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

Locations

Country	Name	City	State
United States	Friendship Public Charter School	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Howard University	Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival inflammation	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; Mild inflammation- Slight change in color and mild edema with little change in texture. No bleeding on probing.; Moderate inflammation- moderate glazing, redness, edema and hypertrophy. Bleeding on probing.; Severe inflammation- Marked redness, hypertrophy, edema and ulceration. Tendency for spontaneous bleeding.	All outcomes will be measured at baseline, at1 month, 3 months and at 6 months
Secondary	Plaque scores	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	All outcomes will be measured at baseline, 1 month, 3 months and at 6 months
Secondary	Knowledge assessment	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.")	All outcomes will be measured at baseline, 1 month, 3 months and at 6 months
Secondary	Efficacy assessment	Efficacy will be assessed using a validated 6 item oral health self-efficacy scale	All outcomes will be measured at baseline, 1 month, 3months and at 6 months
Secondary	Motivation assessment	Motivation will be assessed using a single item 10-point visual analog scale	All outcomes will be measured at baseline, 1 month, 3months and at 6 months