Effects of Adjunctive Synbiotic Supplementation to Non-Surgical Periodontal Therapy on Clinical, Immunological, and Microbiological Parameters in Smokers With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Changes in Probing Pocket Depth (PPD)
研究概览
简要总结
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.
详细描述
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of tooth-supporting tissues, leading to periodontal pocket formation, bleeding on probing, clinical attachment loss, alveolar bone loss, and ultimately tooth loss if untreated. During disease progression, periodontal pathogens stimulate the production of proinflammatory mediators such as IL-1β and IL-8, which contribute to tissue destruction and immune cell recruitment. Excessive inflammatory responses increase reactive oxygen species (ROS) production, resulting in oxidative stress and oxidative DNA damage, commonly assessed by 8-hydroxy-2'-deoxyguanosine (8-OHdG).
Smoking is a major risk factor for periodontitis, as it alters the oral microbiota, impairs immune responses, and increases oxidative stress, often reducing the effectiveness of periodontal therapy. Although non-surgical periodontal therapy is the standard treatment for periodontitis, its outcomes may be limited in smokers and in severe cases.
Synbiotics, which combine probiotics and prebiotics, may help restore microbial balance, modulate host immune responses, and reduce oxidative stress. Therefore, adjunctive synbiotic supplementation alongside non-surgical periodontal therapy may enhance periodontal treatment outcomes, particularly in individuals with periodontitis.
There is limited evidence regarding the combined evaluation of the effects of synbiotic supplementation on clinical periodontal parameters, immunological markers, microbiological parameters, and microbiota in smokers with periodontitis. Therefore, the aim of this placebo-controlled, parallel-group, double-blind, prospective clinical study is to evaluate the effects of adjunctive synbiotic supplementation combined with non-surgical periodontal therapy on clinical periodontal parameters, IL-1β, IL-8, and 8-OHdG levels, periodontal pathogens, and gastrointestinal microbiota in smokers and non-smokers with generalized Stage III/IV Grade B/C periodontitis.
Following Ethics Committee approval, patients diagnosed with generalized Stage III-IV Grade B/C periodontitis, without systemic disease, who apply to the Department of Periodontology at Biruni University Faculty of Dentistry and voluntarily agree to participate in the study will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in Probing Pocket Depth (PPD)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Burcu KARADUMAN
Professor
Biruni University
