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Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

Primary Purpose

Adolescent Behavior, Dental Plaque, Gingivitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral intervention
Colgate smart toothbrush
Sponsored by
Howard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Behavior focused on measuring adolescent health, dental plaque, gingivitis, cognitive change

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Friendship Public Charter SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Test Group I

Control group I

Control group II

Arm Description

A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI)

A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush

A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.")
Efficacy assessment
Efficacy will be assessed using a validated 6 item oral health self-efficacy scale
Motivation assessment
Motivation will be assessed using a single item 10-point visual analog scale

Full Information

First Posted
March 2, 2023
Last Updated
March 13, 2023
Sponsor
Howard University
Collaborators
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT05782348
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
February 6, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Howard University
Collaborators
Temple University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Behavior, Dental Plaque, Gingivitis, Cognitive Change
Keywords
adolescent health, dental plaque, gingivitis, cognitive change

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three arm parallel group single blind study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group I
Arm Type
Experimental
Arm Description
A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI)
Arm Title
Control group I
Arm Type
Active Comparator
Arm Description
A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush
Arm Title
Control group II
Arm Type
No Intervention
Arm Description
A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Colgate smart toothbrush
Intervention Description
A Colgate smart toothbrush that provides the user with details on toothbrushing habits and frequency
Primary Outcome Measure Information:
Title
Gingival inflammation
Description
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.
Time Frame
All outcomes will be measured at baseline, at1 month, 3 months and at 6 months
Secondary Outcome Measure Information:
Title
Plaque scores
Description
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
Time Frame
All outcomes will be measured at baseline, 1 month, 3 months and at 6 months
Title
Knowledge assessment
Description
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.")
Time Frame
All outcomes will be measured at baseline, 1 month, 3 months and at 6 months
Title
Efficacy assessment
Description
Efficacy will be assessed using a validated 6 item oral health self-efficacy scale
Time Frame
All outcomes will be measured at baseline, 1 month, 3months and at 6 months
Title
Motivation assessment
Description
Motivation will be assessed using a single item 10-point visual analog scale
Time Frame
All outcomes will be measured at baseline, 1 month, 3months and at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Laurence, PhD
Phone
5713090308
Email
blaurence@howard.edu
Facility Information:
Facility Name
Friendship Public Charter School
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dianne Harris
Phone
202-578-4031
Email
dharrishealthstrategies1@gmail.com
First Name & Middle Initial & Last Name & Degree
Brian Laurence
First Name & Middle Initial & Last Name & Degree
Eugene Dunne

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual data available to other researchers

Learn more about this trial

Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

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