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← All trials/NCT07478653

Not yet recruitingPhase NA

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

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

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

50

Study population

Obesity / overweight

Eligibility highlights

•Age 12-17

Primary endpoints

•Gingival index•Probing depth•BOP (Bleeding on probing)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07478653
Org study ID108598

Timeline

Milestones

Study first posted2026-03-17actual
Last update posted2026-03-27actual
Study start2026-05-01estimated
Primary completion2028-07-31estimated
Study completion2028-07-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age12 Years
Maximum age17 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
9
Other clinical outcomes
8
Cardiometabolic biomarkers
2

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

Change in levels of C-reactive protein (CRP)

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint

Change in levels of Vascular Endothelial Growth Factor A (VEGF-A)

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Other clinical outcomes

8 endpoints
Primary/protocol endpoint/low confidence

Change in gingival index

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint

Change in probing depth

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in BOP (Bleeding on probing)

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Plaque Index

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Clinical Attachment Level (CAL)

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Gingival Margin Position (GM)

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint

Number of participants with Supragingival and Subgingival Calculus

Time frame:Baseline, 6 months, 12 months

categorical status, descriptive

Primary/protocol endpoint/low confidence

Change in Bacterial Subgingival Biofilm

Time frame:Baseline, 6 months, 12 months

change from baseline, descriptive

Other (unclassified)

9 endpoints
Primary/protocol endpoint/low confidence

Change in Gingival Crevicular Fluid (GCF)

Time frame:Baseline, 6 months, 12 months

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Change in levels of Interleukin-1 beta (IL-1β)

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in levels of Tumor Necrosis Factor-alpha

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in levels of Interleukin-6 (IL-6)

Time frame:Baseline, 6 months, 12 months

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1)

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1)

Time frame:Baseline, 6 months, 12 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in levels of endocan

Time frame:Baseline, 6 months, 12 months

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Change in Oral Microbiome

Time frame:Baseline, 6 months, 12 months

descriptive

Primary/protocol endpoint/low confidence

Change in active oral microbiome (RNA sequencing)

Time frame:Baseline, 6 months, 12 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.