Skip to main content
OpenTrials
Completed

NCT Number: NCT05782348

Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adolescent Behavior Behavior Cognitive Change Dental Deposits Dental Plaque Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friendship Public Charter School

Washington D.C., District of Columbia, 20059, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Intervention

Behavioral

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.

Colgate smart toothbrush

Other

A Colgate smart toothbrush that provides the user with details on toothbrushing habits and frequency

Primary outcomes

  1. 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

    • 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 outcomes

  1. Plaque scores

    Time frame: 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

  2. Knowledge assessment

    Time frame: 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.")

  3. Efficacy assessment

    Time frame: 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

  4. Motivation assessment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Howard University

Other

Collaborators

  • Temple University

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 23, 2023
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.