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

Registration

Registration

NCT07478653

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Status

RECRUITING

Enrollment

50

Start

2026-08-31

Primary completion

2028-07-31

Lead sponsor

Oelisoa Andriankaja

Conditions

Obesity; Dental Care for Children

Interventions

PROCEDURE:Dental Cleaning and Oral Hygiene Instruction (OHI); BEHAVIORAL:Oral Hygiene Instruction (OHI)

Results posted

FALSE

Registered primary outcomes

• Change in gingival index [Baseline, 6 months, 12 months]
• Change in probing depth [Baseline, 6 months, 12 months]
• Change in BOP (Bleeding on probing) [Baseline, 6 months, 12 months]
• Change in Plaque Index [Baseline, 6 months, 12 months]
• Change in Clinical Attachment Level (CAL) [Baseline, 6 months, 12 months]
• Change in Gingival Margin Position (GM) [Baseline, 6 months, 12 months]
• Number of participants with Supragingival and Subgingival Calculus [Baseline, 6 months, 12 months]
• Change in Gingival Crevicular Fluid (GCF) [Baseline, 6 months, 12 months]
• Change in Bacterial Subgingival Biofilm [Baseline, 6 months, 12 months]
• Change in levels of Interleukin-1 beta (IL-1β) [Baseline, 6 months, 12 months]
• Change in levels of Tumor Necrosis Factor-alpha [Baseline, 6 months, 12 months]
• Change in levels of Interleukin-6 (IL-6) [Baseline, 6 months, 12 months]
• Change in levels of C-reactive protein (CRP) [Baseline, 6 months, 12 months]
• Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1) [Baseline, 6 months, 12 months]
• Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1) [Baseline, 6 months, 12 months]
• Change in levels of endocan [Baseline, 6 months, 12 months]
• Change in levels of Vascular Endothelial Growth Factor A (VEGF-A) [Baseline, 6 months, 12 months]
• Change in Oral Microbiome [Baseline, 6 months, 12 months]
• Change in active oral microbiome (RNA sequencing) [Baseline, 6 months, 12 months]