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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

CompletedNA

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

Conditions: Obesity, Periodontitis

Interventions: Laparoscopic Sleeve Gastrectomy, Non-Surgical Obesity Management, Standardized Oral-Hygiene Instructions

Countries: Romania

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age 18 to 65 years.
* Body mass index (BMI) ≥35 kg/m² with one or more obesity-related comorbidities, or BMI ≥40 kg/m².
* Stage I-III periodontitis according to the 2018 periodontitis stage/grade classification.
* At least 12 natural teeth in each dental arch.
* Written informed consent provided before enrollment.

Exclusion Criteria:

* • Smoking more than 10 cigarettes per day.

  * Periodontal treatment within the previous 6 months.
  * Pregnancy or lactation.
  * Previous bariatric surgery.
  * Active autoimmune disorder, malignant disease, or another systemic disease known to markedly affect periodontal inflammation.
  * Recent antibiotic use
  * Recent systemic corticosteroid use
  * Regular non-steroidal anti-inflammatory drug use within 90 days before enrollment.
  * Current anti-obesity glucagon-like peptide-1 (GLP-1) therapy.

Locations (1)

Târgu Mureş, Romania