MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease
Part of paid clinical trials in Lexington, Kentucky.
- Sponsor
- Oelisoa Andriankaja
- Study ID
- NCT07478653
- Status
- Not Yet Recruiting
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Conditions
- Dental Care for Children
- Obesity
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dental Cleaning and Oral Hygiene Instruction (OHI) — PROCEDUREParticipants receive dental cleaning and oral hygiene instruction (OHI) and oral health assessments at baseline (prior to initiating weight-loss medication), 6 months (±2 weeks), and 12 months (±1 month) post-enrollment.
- Oral Hygiene Instruction (OHI) — BEHAVIORALParticipants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months.
Study Details
The goal of this clinical trial is to assess whether adjunctive dental cleaning can enhance the effects of semaglutide in children with obesity. The main question\[s\] it aims to answer \[is/are\]: if dental cleaning will improve both oral health and metabolic outcomes beyond the effects of semaglutide alone. Participants will receive either dental cleaning and oral hygiene instruction or oral hygiene instruction alone.
Key Dates
- Start date
- May 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Jul 31, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Dental cleaning and Oral Hygiene Instruction (OHI)
- Active Comparator: Oral Hygiene Instruction (OHI) only
Primary Outcome Measure
Change in gingival index [ Time Frame: Baseline, 6 months, 12 months ]
Central Contacts
- Oelisoa Mireille Andriankaja, DDS, MS, PhD8595620597
- Shaddox
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | - |
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