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Cognitive Behavioral Therapy + Smart Toothbrush for Oral Health
N/A
Recruiting
Research Sponsored by Howard University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all outcomes will be measured at baseline, at1 month, 3 months and at 6 months
Awards & highlights
Study Summary
This trial studies if a smart toothbrush + a special intervention can help teens have better oral health.
Who is the study for?
This trial is for high school students with gum disease or dental plaque issues. They must have consent from a caregiver and give their own assent to participate. It's not open to those on blood thinners, undergoing chemotherapy, with leukemia, heart valve prosthetics, past infective endocarditis, joint replacements, or organ transplants.Check my eligibility
What is being tested?
The study tests if adding cognitive behavioral strategies to using a smart toothbrush can improve oral health in adolescents. Participants are randomly assigned into three groups: one gets the CBI plus the smart toothbrush; others may receive different combinations.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like behavior strategies and an electronic toothbrush, side effects might be minimal but could include discomfort from changing habits or potential gum irritation from new brushing techniques.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all outcomes will be measured at baseline, at1 month, 3 months and at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all outcomes will be measured at baseline, at1 month, 3 months and at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gingival inflammation
Secondary outcome measures
Efficacy assessment
Knowledge assessment
Motivation assessment
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Test Group IExperimental Treatment2 Interventions
A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush Cognitive behavioral intervention (CBI)
Group II: Control group IActive Control1 Intervention
A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush
Group III: Control group IIActive Control1 Intervention
A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive behavioral intervention
2021
N/A
~510
Find a Location
Who is running the clinical trial?
Howard UniversityLead Sponsor
39 Previous Clinical Trials
13,093 Total Patients Enrolled
Temple UniversityOTHER
297 Previous Clinical Trials
82,823 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is currently undergoing chemotherapy.I have had infective endocarditis before.I have had joint replacement surgery.My child has leukemia.My child is on blood thinner medication like Coumadin or Rivaroxaban.My child has had an organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Test Group I
- Group 2: Control group I
- Group 3: Control group II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation accept adult participants?
"As per the study protocols, only individuals aged between 14 and 17 are allowed to take part in this clinical trial."
Answered by AI
How do I qualify for enrollment in this research endeavor?
"Applicants eligible to partake in this clinical trial must exhibit adolescent behaviors and be aged between 14-17. In total, 150 individuals are being recruited for the study."
Answered by AI
Are there still opportunities for enrolment in this research program?
"Affirmative. The clinical trial database indicates that this research is currently recruiting patients, which was initially advertised on February 6th 2023 and recently updated on March 13th 2023. 150 participants must be sourced from a single medical centre."
Answered by AI
How many participants is this clinical trial currently enrolling?
"Affirmative. Per the information on clinicaltrials.gov, this medical trial is presently appending its cohort of research subjects. Originally posted to the website on February 6th 2023 and most recently edited on March 13th 2023, 150 people are needed between 1 locations for participation in this experiment."
Answered by AI
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