Effects of Adjunctive Synbiotic Supplementation to Non-Surgical Periodontal Therapy in Smokers With Periodontitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Synbiotic supplementation: Product Name: Bigflor Capsule Food Supplement Containing Probiotic Microorganisms Approval Number: 005400-08.02.2019 Manufacturer: Nuvita İlaç ve Kimya Sanayi Ticaret Anonim Şirketi Manufacturer Registration/Approval Number: TR-34-K-063184 Contents: Saccharomyces boulardii (5×10⁹ cfu/day) - 250 mg Probiotic Blend (3.5×10⁹ cfu/day) (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Streptococcus thermophilus) - 22.5 mg Prebiotic (Inulin) - 25 mg

Placebo Administration: The use of a placebo in the control group

Study 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

Primary outcome measure(s)

• Changes in Probing Pocket Depth (PPD) — Baseline and 3 months after non-surgical periodontal therapy
  Evaluation of changes in probing pocket depth following non-surgical periodontal therapy combined with synbiotic or placebo supplementation in smokers and non-smokers with generalized Stage III-IV Grade B/C periodontitis.
• Gain in Clinical Attachment Level (CAL) — Baseline and 3 months after non-surgical periodontal therapy
  Evaluation of changes in clinical attachment level following non-surgical periodontal therapy combined with synbiotic or placebo supplementation in smokers and non-smokers with generalized Stage III-IV Grade B/C periodontitis.

Trial sites (1)

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