Recruiting

Semaglutide with Dental Cleaning

Sponsor:

Oelisoa Andriankaja

Code:

NCT07478653

Conditions

Obesity

Dental Care for Children

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Dental Cleaning and Oral Hygiene Instruction (OHI)

Oral Hygiene Instruction (OHI)

Study Details

Brief 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.

Conditions

Obesity

Dental Care for Children

Study ID

NCT07478653

Start date

Aug 31, 2026

Status verified date

Oct, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Dental cleaning and Oral Hygiene Instruction (OHI)

active comparator: Oral Hygiene Instruction (OHI) only

Interventions

Dental Cleaning and Oral Hygiene Instruction (OHI)

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)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Oelisoa Mireille Andriankaja, DDS, MS, PhD

8595620597oelisoa.andriankaja@uky.edu

Shaddox

oelisoa.andriankaja@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

More Information

Sponsor

Oelisoa Andriankaja

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Oelisoa Andriankaja on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.