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

MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease: Effects Of Semaglutide Treatment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding dental cleaning to semaglutide helps children with obesity improve their mouth health and how their bodies use food for energy. It is for children already in the MODERN study. All participants will get tips on caring for their teeth, and some will also get dental cleaning.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Already taking part in the MODERN study (NCT06967389).
  • Have class 2 or 3 obesity. The listing gives a body mass index (BMI) of 120% of the 95th percentile for age and sex, a measure comparing body size with other children.

Who can't join

  • Meet any rule that excludes someone from the main MODERN study. Those rules are not listed here.
  • Plan to receive or finish dental care during the 12-month study.
  • Are getting treatment to straighten teeth or fix their bite.
  • Used medicine to reduce inflammation, other than steroids, within 1 month before joining.
  • Take medicines that could affect gum disease or its treatment, such as steroids or medicines that weaken the immune system.
  • Used antibiotics applied to one area or taken for the whole body within 15 days before joining, or for more than 10 days in the past 3 months.
  • Have a history of bleeding disorders.
  • Had a professional dental cleaning or gum treatment without surgery in the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

KY