Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
| Periodontitis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Sleeve Gastrectomy | Procedure | — | UNRESOLVED |
| Non-Surgical Obesity Management | Other | — | UNRESOLVED |
| Standardized Oral-Hygiene Instructions | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sleeve Gastrectomy Group (SG)
- description
- Participants allocated to SG underwent laparoscopic sleeve gastrectomy and completed anthropometric, periodontal, and saliva assessments at baseline, 3 months, and 6 months. They also received standardized oral-hygiene instructions at baseline; no periodontal treatment was provided during follow-up unless clinically necessary.
- interventionNames
- Procedure: Laparoscopic Sleeve Gastrectomy
- Other: Non-Surgical Obesity Management
- Behavioral: Standardized Oral-Hygiene Instructions
- type
- ACTIVE_COMPARATOR
- label
- Non-Surgical Management Group (NSG)
- description
- Participants allocated to NSG received non-surgical management over the same follow-up period and completed anthropometric, periodontal, and saliva assessments at baseline, 3 months, and 6 months. They also received standardized oral-hygiene instructions at baseline; no periodontal treatment was provided during follow-up unless clinically necessary
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDBeresescu FG, Monea A, Ormenisan A, Tegla C, Cosarca A, Voidazan S. Short-Term Changes in Salivary IL-6, TNF-alpha, and Periodontal Inflammation Following Sleeve Gastrectomy in Patients with Obesity: A Randomized Controlled Pilot Study. Biomedicines. 2026 Aug 4;14(8):1759. doi: 10.3390/biomedicines14081759. PMID 42652142