Not Yet RecruitingNot Applicable

MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease

United States50 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in gingival index

Timeframe: Baseline, 6 months, 12 months

Change in probing depth

Timeframe: Baseline, 6 months, 12 months

Change in BOP (Bleeding on probing)

Timeframe: Baseline, 6 months, 12 months

Change in Plaque Index

Timeframe: Baseline, 6 months, 12 months

Change in Clinical Attachment Level (CAL)

Timeframe: Baseline, 6 months, 12 months

Change in Gingival Margin Position (GM)

Timeframe: Baseline, 6 months, 12 months

Number of participants with Supragingival and Subgingival Calculus

Timeframe: Baseline, 6 months, 12 months

Trial details

NCT IDNCT07478653

SponsorOelisoa Andriankaja

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Oelisoa Mireille Andriankaja, DDS, MS, PhD

8595620597 oelisoa.andriankaja@uky.edu

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in gingival index

Timeframe: Baseline, 6 months, 12 months

Change in probing depth

Timeframe: Baseline, 6 months, 12 months

Change in BOP (Bleeding on probing)

Timeframe: Baseline, 6 months, 12 months

Change in Plaque Index

Timeframe: Baseline, 6 months, 12 months

Change in Clinical Attachment Level (CAL)

Timeframe: Baseline, 6 months, 12 months

Change in Gingival Margin Position (GM)

Timeframe: Baseline, 6 months, 12 months

Number of participants with Supragingival and Subgingival Calculus

Timeframe: Baseline, 6 months, 12 months