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NCT07672379
Effects of Adjunctive Synbiotic Supplementation to Non-Surgical Periodontal Therapy in Smokers With Periodontitis
Conditions: Periodontal Disease
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 92
Sponsor: Biruni University
Location: Biruni University Istanbul Istanbul
Summary
The aim of this study is to evaluate the effects of adjunctive synbiotic supplementation combined with non-surgical periodontal therapy in smokers with periodontitis. The main questions this study aims to answer are:
Does adjunctive synbiotic supplementation improve clinical periodontal parameters in smokers with periodontitis? Does adjunctive synbiotic supplementation affect immunological and microbiological parameters associated with periodontal disease?
Systemically healthy smokers and non-smokers diagnosed with generalized Stage III-IV Grade B/C periodontitis will be included in the study. Participants will first be divided into two main groups according to smoking status (smokers and non-smokers). These groups will then be further divided into two subgroups according to the use of synbiotic or placebo capsules. Therefore, the study will consist of four groups in total. The sample size of the study was determined as 92 participants, with 23 participants included in each group.
All participants will receive non-surgical periodontal therapy (NSPT) at baseline. In addition to NSPT, participants will use either synbiotic or placebo capsules once daily for 90 days.
To evaluate clinical periodontal, immunological, and microbiological parameters, periodontal measurements will be performed, and saliva and subgingival plaque samples will be collected. In addition, stool samples will be collected from participants to evaluate the effects of synbiotic supplementation on the gastrointestinal microbiota, and microbiota analyses will be performed.
All samples will be collected again and evaluated at the third month following non-surgical periodontal therapy.
Eligibility Criteria
Inclusion Criteria:
* Age between 18 and 65 years
* Diagnosis of generalized Stage III/IV Grade B/C periodontitis
* Willingness to participate in the study and provide informed consent
* No periodontal treatment within the last 3 months
* No use of antibiotics or anti-inflammatory drugs within the last 3 months
* Not being pregnant or breastfeeding
* Presence of at least 20 teeth
* Body mass index (BMI) between 18.5 and 30 kg/m²
Exclusion Criteria:
* Failure to meet voluntary participation requirements
* Presence of systemic diseases affecting the periodontium or immune response
* Use of additional dietary supplements
* Pregnancy or breastfeeding
* Use of immunosuppressive medications Individuals who may have difficulty complying with the study protocol
Source: ClinicalTrials.gov (NCT07672379). StuddyBuddy aggregates publicly available trial information.