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

NCT07672379 | Not Yet Recruiting

• 1 other identifier: 2026-08
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Disease

Keywords

Periodontitis; Non-surgical periodontal treatment; Synbiotic; Probiotic

Outcome Measures

Primary Outcomes (2)

• Changes in Probing Pocket Depth (PPD)

  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.

  Baseline and 3 months after non-surgical periodontal therapy

• Gain in Clinical Attachment Level (CAL)

  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.

  Baseline and 3 months after non-surgical periodontal therapy

Secondary Outcomes (5)

• Quantitative Changes in Periodontal Pathogens

  Baseline and 3 months after non-surgical periodontal therapy

• Changes in IL-1β, IL-8, and 8-OHdG Levels

  Baseline and 3 months after non-surgical periodontal therapy

• Changes in Plaque Index

  Baseline and 3 months after non-surgical periodontal therapy

• Changes in Bleeding on Probing

  Baseline and 3 months after non-surgical periodontal therapy

• Changes in Gastrointestinal Microbiota

  Baseline and 3 months after non-surgical periodontal therapy

Study Arms (4)

SS (Smokers + Synbiotic)

EXPERIMENTAL

Participants with generalized Stage III-IV Grade B/C periodontitis who smoke and receive synbiotic supplementation once daily for 90 days in addition to non-surgical periodontal therapy.

Dietary Supplement: Synbiotic supplementation

SP (Smokers + Placebo)

PLACEBO COMPARATOR

Participants with generalized Stage III-IV Grade B/C periodontitis who smoke and receive placebo supplementation once daily for 90 days in addition to non-surgical periodontal therapy.

Other: Placebo Administration

NS (Non-smokers + Synbiotic)

EXPERIMENTAL

Non-smoking participants with generalized Stage III-IV Grade B/C periodontitis who receive synbiotic supplementation once daily for 90 days in addition to non-surgical periodontal therapy.

Dietary Supplement: Synbiotic supplementation

NP (Non-smokers + Placebo)

PLACEBO COMPARATOR

Non-smoking participants with generalized Stage III-IV Grade B/C periodontitis who receive placebo supplementation once daily for 90 days in addition to non-surgical periodontal therapy.

Other: Placebo Administration

Interventions

Synbiotic supplementation DIETARY_SUPPLEMENT

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

NS (Non-smokers + Synbiotic); SS (Smokers + Synbiotic)

Placebo Administration OTHER

The use of a placebo in the control group

NP (Non-smokers + Placebo); SP (Smokers + Placebo)

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead
• KU Leuven: collaborator

Study Sites (1)

Biruni University

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (2)

• Ausenda F, Barbera E, Cotti E, Romeo E, Natto ZS, Valente NA. Clinical, microbiological and immunological short, medium and long-term effects of different strains of probiotics as an adjunct to non-surgical periodontal therapy in patients with periodontitis. Systematic review with meta-analysis. Jpn Dent Sci Rev. 2023 Dec;59:62-103. doi: 10.1016/j.jdsr.2023.02.001. Epub 2023 Mar 4.

  PMID: 36915665 BACKGROUND

• Bazyar H, Maghsoumi-Norouzabad L, Yarahmadi M, Gholinezhad H, Moradi L, Salehi P, Haghighi-Zadeh MH, Zare Javid A. The Impacts of Synbiotic Supplementation on Periodontal Indices and Biomarkers of Oxidative Stress in Type 2 Diabetes Mellitus Patients with Chronic Periodontitis Under Non-Surgical Periodontal Therapy. A Double-Blind, Placebo-Controlled Trial. Diabetes Metab Syndr Obes. 2020 Jan 6;13:19-29. doi: 10.2147/DMSO.S230060. eCollection 2020.

  PMID: 32021348 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Burcu Karaduman

  Biruni University, Faculty of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burcu Karaduman, PhD

CONTACT

+90 444 8 276; bkaraduman@biruni.edu.tr

İrem Özdoğan, DDS

CONTACT

+90 444 8 276; 221115003@st.biruni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 26, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): October 6, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)