MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease: Effects Of Semaglutide Treatment
Oelisoa Andriankaja
Summary
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.
Description
Parent study NCT06967389
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * participants from the ongoing Mitigation of Cardiovascular Disease Risks in Children with Extreme Obesity (MODERN) study (NCT06967389) * Class 2 or 3 obesity (BMI =120% of the 95th percentile for age and sex) Exclusion Criteria: * Same exclusion as parent study. * Planning to receive or complete dental services during the 12-month course of the study * Ongoing orthodontic treatment * Use of any anti-inflammatory medication (other than steroids) within 1 month prior to enrollment * Currently taking medications that could influence the characteristics or response to peri…
Interventions
- ProcedureDental Cleaning and Oral Hygiene Instruction (OHI)
Participants 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.
- BehavioralOral Hygiene Instruction (OHI)
Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months.
Location
- University of KentuckyLexington, Kentucky