What this study is
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.
What's being tested
- Dental Cleaning and Oral Hygiene Instruction (OHI)
Intervention · PROCEDURE
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.
- Oral Hygiene Instruction (OHI)
Intervention · BEHAVIORAL
Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months.
Study details
- Official title
- MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease: Effects Of Semaglutide Treatment
- Sponsor
- Oelisoa Andriankaja
- Conditions
- Obesity · Dental Care for Children
- Enrolling
- 50 people
- Starts
- 2026-08-31
- Est. completion
- 2028-07-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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 periodontal treatment (e.g., use of immunosuppressants or steroids)
- Local or systemic antibiotic use within 15 days prior to enrollment or for >10 days within the past 3 months
- History of bleeding disorders
- Professional dental prophylaxis or non-surgical periodontal therapy within the past 6 months
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Kentucky
Lexington, Kentucky, United States
Recruiting
Study team
Sponsor
Oelisoa Andriankaja
Study ID 108598
Principal investigator
Oelisoa Andriankaja, DDS, PhD
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.