Short-Term Changes in Salivary IL-6, TNF-α, and Periodontal Inflammation Following Sleeve Gastrec… (NCT07731412) | Clinical Trial Compass
CompletedNot Applicable
Short-Term Changes in Salivary IL-6, TNF-α, and Periodontal Inflammation Following Sleeve Gastrectomy in Patients With Obesity: A Randomized Controlled Pilot Study
Romania32 participantsStarted 2022-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in salivary interleukin-6 (IL-6) concentration at 3 and 6 months
Timeframe: Baseline, 3 months, and 6 months
2
Change from baseline in salivary tumor necrosis factor-alpha (TNF-α) concentration at 3 and 6 months
Timeframe: Baseline, 3 months, and 6 months
Trial details
NCT IDNCT07731412
SponsorGeorge Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures