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

NCT07731412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2025-04-15
Completion
2025-12-30

Countries

  • Romania

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731412 on ClinicalTrials.gov