NCT07731412Completed
Short-Term Changes in Salivary IL-6, TNF-α, and Periodontal Inflammation Following Sleeve Gastrectomy in Patients With Obesity: A Randomized Controlled Pilot Study
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 23 Jul 2026
- Start date
- 1 Dec 2022
- Primary completion date
- 15 Apr 2025
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Diseases
- Obesity
- NCT number
- NCT07731412
What you commit to
- Study type: Interventional
- Participants enrolled: 32
- From 1 Dec 2022 to the primary completion date, 15 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.