Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

Study Overview
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Brief Summary
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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
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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

Official Title
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Clinical Study to Evaluate the Effectiveness of a Cognitive Behavioral Intervention (CBI) Adjunctive to a Smart Powered Toothbrush on the Oral Health of Adolescents

Conditions
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Adolescent Behavior, Dental Plaque, Gingivitis, Cognitive Change

Intervention / Treatment
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* Behavioral: Cognitive behavioral intervention
* Other: Colgate smart toothbrush


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three arm parallel group single blind study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group I<br>A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI) | Behavioral: Cognitive behavioral intervention<br>* 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.<br>Other: Colgate smart toothbrush<br>* A Colgate smart toothbrush that provides the user with details on toothbrushing habits and frequency<br>|
| Active Comparator: Control group I<br>A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush | Other: Colgate smart toothbrush<br>* A Colgate smart toothbrush that provides the user with details on toothbrushing habits and frequency<br>|
| No Intervention: Control group II<br>A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent health, dental plaque, gingivitis, cognitive change