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NCT Number: NCT07478653

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

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.

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Key information

Conditions

Obesity Body Weight Dental Care for Children Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

About this study

Parent study NCT06967389

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental Cleaning and Oral Hygiene Instruction (OHI)

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)

Behavioral

Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months.

Primary outcomes

  1. Change in gingival index

    Time frame: Baseline, 6 months, 12 months

    Based on visual assessment and gentle probing of the marginal periodontal tissues. Scored on a 0-3 scale and the higher score means increased inflammation.

  2. Change in probing depth

    Time frame: Baseline, 6 months, 12 months

    Measuring the pocket depth at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.

  3. Change in BOP (Bleeding on probing)

    Time frame: Baseline, 6 months, 12 months

    Presence or absence of bleeding upon probing recorded at six sites per tooth.

  4. Change in Plaque Index

    Time frame: Baseline, 6 months, 12 months

    Measured using a plaque score (0-3) at six specific Ramfjord teeth

  5. Change in Clinical Attachment Level (CAL)

    Time frame: Baseline, 6 months, 12 months

    Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site.

  6. Change in Gingival Margin Position (GM)

    Time frame: Baseline, 6 months, 12 months

    Recorded at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.

  7. Number of participants with Supragingival and Subgingival Calculus

    Time frame: Baseline, 6 months, 12 months

    Recorded as present or absent, generalized or localized when visible or detected upon probing.

  8. Change in Gingival Crevicular Fluid (GCF)

    Time frame: Baseline, 6 months, 12 months

    Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites.

  9. Change in Bacterial Subgingival Biofilm

    Time frame: Baseline, 6 months, 12 months

    Collected from the same sites as GCF using sterile endodontic paper points.

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

    Time frame: Baseline, 6 months, 12 months

    levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  11. Change in levels of Tumor Necrosis Factor-alpha

    Time frame: Baseline, 6 months, 12 months

    levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

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

    Time frame: Baseline, 6 months, 12 months

    levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  13. Change in levels of C-reactive protein (CRP)

    Time frame: Baseline, 6 months, 12 months

    levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

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

    Time frame: Baseline, 6 months, 12 months

    levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

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

    Time frame: Baseline, 6 months, 12 months

    levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  16. Change in levels of endocan

    Time frame: Baseline, 6 months, 12 months

    levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

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

    Time frame: Baseline, 6 months, 12 months

    levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame

  18. Change in Oral Microbiome

    Time frame: Baseline, 6 months, 12 months

    DNA sequencing. Saliva will be collected.

  19. Change in active oral microbiome (RNA sequencing)

    Time frame: Baseline, 6 months, 12 months

    RNA sequencing. Saliva will be collected.

Study contacts

Contact information is provided by the study sponsor or research team.

Oelisoa Mireille Andriankaja, DDS, MS, PhD

CONTACT

[email protected]

8595620597

Shaddox

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Oelisoa Andriankaja

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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