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Adolescent BehaviorNCT05782348

Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

A study testing Cognitive behavioral intervention and Colgate smart toothbrush in people with Adolescent Behavior and Dental Plaque, run by Howard University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Adolescent Behavior, Dental Plaque, Gingivitis
What is being tested?
Cognitive behavioral intervention and Colgate smart toothbrush
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
6 Aug 2023to 28 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Students are enrolled in participating high schools Caregivers give informed consent Student gives assent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Friendship Public Charter School

    Washington D.C., District of Columbia, 20059

Other trials in United States

About this study

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

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.

Read the 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

Being tested
Cognitive behavioral intervention, Colgate smart toothbrush
Keywords
adolescent health, dental plaque, gingivitis, cognitive change
Medical subject headings
Adolescent Behavior, Dental Plaque, Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive behavioral interventionBehavioural

    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 toothbrushOther

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

Study groups in NCT05782348
Study groupRoleWhat they receive
Test Group IExperimentalA commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI)
Receives: Behavioral: Cognitive behavioral intervention; Other: Colgate smart toothbrush
Control group IActive comparatorA commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush
Receives: Other: Colgate smart toothbrush
Control group IINo interventionA commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: All outcomes will be measured at baseline, at1 month, 3 months and at 6 months

Secondary outcomes (4)

  1. 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

    Measured: All outcomes will be measured at baseline, 1 month, 3 months and at 6 months

  2. 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.")

    Measured: All outcomes will be measured at baseline, 1 month, 3 months and at 6 months

  3. Efficacy assessment

    Efficacy will be assessed using a validated 6 item oral health self-efficacy scale

    Measured: All outcomes will be measured at baseline, 1 month, 3months and at 6 months

  4. Motivation assessment

    Motivation will be assessed using a single item 10-point visual analog scale

    Measured: All outcomes will be measured at baseline, 1 month, 3months and at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2023
  2. Study start6 Aug 2023
  3. Primary completion6 Apr 2024
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three arm parallel group single blind study
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05782348
Sponsor's protocol ID
CRO-2022-10-CBT-HU-US-BS
Status last verified
Apr 2025
First submitted
2 Mar 2023
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual data available to other researchers

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive behavioral intervention and Colgate smart toothbrush in people with Adolescent Behavior and Dental Plaque, run by Howard University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival inflammation (time frame: All outcomes will be measured at baseline, at1 month, 3 months and at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05782348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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