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COMPLETED
NCT07731412
NA

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

Sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2022-12-01

Completion Date

2025-12-30

Last Updated

2026-07-28

Healthy Volunteers

No

Interventions

PROCEDURE

Laparoscopic Sleeve Gastrectomy

Participants randomized to the SG arm underwent laparoscopic sleeve gastrectomy as their obesity treatment.

OTHER

Non-Surgical Obesity Management

conservative management

BEHAVIORAL

Standardized Oral-Hygiene Instructions

All participants received standardized oral-hygiene instructions at baseline and were advised to maintain their usual oral-care habits throughout follow-up. No periodontal treatment was provided during follow-up unless clinically necessary

Locations (1)

George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures

Târgu Mureş, Romania