Clinical Trial

Short-Term Changes in Salivary IL-6, TNF-α, and Periodontal Inflammation Following Sleeve Gastrectomy in Patients With Obesity: A Randomized Controlled Pilot Study

Completed
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Summary
Obesity and periodontitis are chronic inflammatory conditions that may share biological pathways. This pilot randomized controlled study compared adults with obesity and stage I-III periodontitis assigned to laparoscopic sleeve gastrectomy or non-surgical management. Participants underwent body measurements, a full-mouth periodontal examination, and unstimulated saliva collection at baseline, 3 months, and 6 months. Salivary interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α) were measured by enzyme-linked immunosorbent assay. The primary outcomes were changes in salivary IL-6 and TNF-α. Secondary outcomes included changes in plaque index, bleeding on probing, probing pocket depth, and clinical attachment level. Body weight and body mass index were measured as contextual outcomes, and exploratory analyses examined associations between cytokine and periodontal changes. The pilot was intended to test feasibility, refine measurement procedures, and estimate preliminary effect sizes for a future definitive trial.
Trial Details
NCT Number NCT07731412
Lead Sponsor George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Conditions Obesity, Periodontitis
Enrollment 32 participants
Start Date 2022-12-01
Primary Completion 2025-04-15 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-28