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 | Completed

• 2 other identifiers: No.1863/15.09.2022Research Grant Number 511/2/17
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Obesity; Periodontitis

Keywords

Bariatric Surgery; Sleeve Gastrectomy; Interleukin-6; Tumor Necrosis Factor-alpha; Periodontal Inflammation; Plaque Index; Bleeding on Probing

Outcome Measures

Primary Outcomes (2)

• Change from baseline in salivary interleukin-6 (IL-6) concentration at 3 and 6 months

  Unstimulated whole saliva is collected by passive drooling for 5 minutes between 08:00 and 10:00 after at least 2 hours without eating, drinking, smoking, toothbrushing, or mouthrinse use. Samples are centrifuged at 3000 rpm for 10 minutes at 4 °C, aliquoted, and stored at -80 °C. IL-6 is measured with a commercial ELISA kit in duplicate; the duplicate mean is reported in pg/mL. The outcome is the within-participant change from baseline at each follow-up, with the principal endpoint at 6 months.

  Baseline, 3 months, and 6 months

• Change from baseline in salivary tumor necrosis factor-alpha (TNF-α) concentration at 3 and 6 months

  Unstimulated whole saliva is collected and processed under the same standardized conditions as for IL-6. TNF-α is measured with a commercial ELISA kit in duplicate; the duplicate mean is reported in pg/mL. The outcome is the within-participant change from baseline at each follow-up, with the principal endpoint at 6 months

  Baseline, 3 months, and 6 months

Secondary Outcomes (4)

• Change from baseline in full-mouth Plaque Index at 3 and 6 months

  Baseline, 3 months, and 6 months

• Change from baseline in bleeding on probing at 3 and 6 months

  Baseline, 3 months, and 6 months

• Change from baseline in full-mouth mean probing pocket depth at 3 and 6 months

  Baseline, 3 months, and 6 months

• Change from baseline in full-mouth mean clinical attachment level at 3 and 6 months

  Baseline, 3 months, and 6 months

Other Outcomes (3)

• Change from baseline in body mass index at 3 and 6 months

  Baseline, 3 months, and 6 months

• Change from baseline in body weight at 3 and 6 months

  Baseline, 3 months, and 6 months

• Association between salivary cytokine concentrations and periodontal clinical measures

  Baseline, 3 months, and 6 months; change from baseline to 6 months

Study Arms (2)

Sleeve Gastrectomy Group (SG)

EXPERIMENTAL

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.

Procedure: Laparoscopic Sleeve Gastrectomy; Other: Non-Surgical Obesity Management; Behavioral: Standardized Oral-Hygiene Instructions

Non-Surgical Management Group (NSG)

ACTIVE COMPARATOR

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

Procedure: Laparoscopic Sleeve Gastrectomy; Other: Non-Surgical Obesity Management; Behavioral: Standardized Oral-Hygiene Instructions

Interventions

Laparoscopic Sleeve Gastrectomy PROCEDURE

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

Non-Surgical Management Group (NSG); Sleeve Gastrectomy Group (SG)

Non-Surgical Obesity Management OTHER

conservative management

Non-Surgical Management Group (NSG); Sleeve Gastrectomy Group (SG)

Standardized Oral-Hygiene Instructions BEHAVIORAL

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

Non-Surgical Management Group (NSG); Sleeve Gastrectomy Group (SG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Târgu Mureş, 540136, Romania

Location

Related Publications (1)

• Beresescu FG, Monea A, Ormenisan A, Tegla C, Cosarca A, Voidazan S. Short-Term Changes in Salivary IL-6, TNF-α, and Periodontal Inflammation following Sleeve Gastrectomy in Patients with Obesity: A Randomized Controlled Pilot Study. Biomedicines

  BACKGROUND

MeSH Terms

Conditions

Obesity; Periodontitis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The intervention was open label. The manuscript does not report blinding of the periodontal examiner or laboratory personnel.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Participants were randomly assigned to laparoscopic sleeve gastrectomy or non-surgical management. Simple computer-generated randomization was used without blocking or stratification. The unequal 18/14 allocation arose by chance in the small pilot sample; no post-allocation rebalancing was performed.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: December 1, 2022
• Primary Completion: April 15, 2025
• Study Completion: December 30, 2025
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

RO (1)