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.
Parent study NCT06967389
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
50
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.
Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months.
University of Kentucky
Lexington, Kentucky, United States
Change in gingival index
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.
Time frame: Baseline, 6 months, 12 months
Change in probing depth
Measuring the pocket depth at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Time frame: Baseline, 6 months, 12 months
Change in BOP (Bleeding on probing)
Presence or absence of bleeding upon probing recorded at six sites per tooth.
Time frame: Baseline, 6 months, 12 months
Change in Plaque Index
Measured using a plaque score (0-3) at six specific Ramfjord teeth
Time frame: Baseline, 6 months, 12 months
Change in Clinical Attachment Level (CAL)
Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site.
Time frame: Baseline, 6 months, 12 months
Change in Gingival Margin Position (GM)
Recorded at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Time frame: Baseline, 6 months, 12 months
Number of participants with Supragingival and Subgingival Calculus
Recorded as present or absent, generalized or localized when visible or detected upon probing.
Time frame: Baseline, 6 months, 12 months
Change in Gingival Crevicular Fluid (GCF)
Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites.
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Time frame: Baseline, 6 months, 12 months
Change in Bacterial Subgingival Biofilm
Collected from the same sites as GCF using sterile endodontic paper points.
Time frame: Baseline, 6 months, 12 months
Change in levels of Interleukin-1 beta (IL-1β)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Time frame: Baseline, 6 months, 12 months
Change in levels of Tumor Necrosis Factor-alpha
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Time frame: Baseline, 6 months, 12 months
Change in levels of Interleukin-6 (IL-6)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Time frame: Baseline, 6 months, 12 months
Change in levels of C-reactive protein (CRP)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Time frame: Baseline, 6 months, 12 months
Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Time frame: Baseline, 6 months, 12 months
Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Time frame: Baseline, 6 months, 12 months
Change in levels of endocan
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Time frame: Baseline, 6 months, 12 months
Change in levels of Vascular Endothelial Growth Factor A (VEGF-A)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Time frame: Baseline, 6 months, 12 months
Change in Oral Microbiome
DNA sequencing. Saliva will be collected.
Time frame: Baseline, 6 months, 12 months
Change in active oral microbiome (RNA sequencing)
RNA sequencing. Saliva will be collected.
Time frame: Baseline, 6 months, 12 months