The Role of Probiotics and Dietary Interventions in the Treatment of Periodontitis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Probing Depth (PD) from Baseline to 6 Weeks, measured in millimeters (mm)
研究概览
简要总结
The aim of this study is to evaluate the effects of probiotic supplementation and diet-supported probiotic use on periodontal clinical parameters in individuals with periodontitis. A total of 120 female participants aged between 20-60 years, diagnosed with periodontitis and without systemic diseases, were included in the study. Participants are randomly assigned into three groups: a control group (conventional treatment), a probiotic group (conventional treatment + probiotics), and a diet + probiotic group (conventional treatment + probiotics + personalized diet). Clinical evaluations are performed using measurements of probing depth (PD) and clinical attachment loss (CAL), while dietary intake is assessed using three-day food records. The collected data will be analyzed using SPSS 21.0 software, and a p-value <0.05 will be considered statistically significant.
详细描述
Periodontitis is a chronic inflammatory disease that results in the destruction of the supporting tissues of the teeth, potentially leading to tooth loss if left untreated. While conventional periodontal treatment focuses on mechanical removal of plaque and calculus, there is increasing interest in adjunctive therapies that target the host response and the oral microbiome.
Probiotic supplementation has been suggested as a potential supportive approach in periodontal therapy, owing to its ability to modulate the microbial balance and reduce inflammation. Moreover, dietary habits-especially the intake of protein, fiber, sugar, and carbohydrates-may influence periodontal health by affecting systemic and local inflammatory responses.
This randomized controlled clinical trial investigates the effects of probiotic supplementation and a personalized anti-inflammatory diet in individuals with periodontitis. A total of 120 female participants aged 20 to 60 years, without systemic diseases, are included. The participants are randomly assigned into three parallel groups:
Control group: conventional non-surgical periodontal treatment
Probiotic group: conventional treatment + probiotic supplementation
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged between 20 and 60 years Clinical diagnosis of periodontitis Presence of at least 20 natural teeth Probing depth between 3 mm and 7 mm (mild to moderate periodontitis) No history of systemic diseases Willingness to participate and provide written informed consent
排除标准
- •Use of antibiotics or probiotics within the past 6 months Current pregnancy or lactation Smoking Presence of systemic conditions such as diabetes or cardiovascular disease Fewer than 20 natural teeth Inability or unwillingness to comply with study procedures
研究组 & 干预措施
Probiotic group
traditional periodontitis treatment + probiotic support
干预措施: Non-Surgical Periodontal Treatment (Procedure)
Probiotic group
traditional periodontitis treatment + probiotic support
干预措施: Probiotic Supplementation (Dietary Supplement)
control group
traditional periodontitis treatment
干预措施: Non-Surgical Periodontal Treatment (Procedure)
Probiotic+diet group
traditional periodontitis treatment + probiotic support + diet
干预措施: Non-Surgical Periodontal Treatment (Procedure)
Probiotic+diet group
traditional periodontitis treatment + probiotic support + diet
干预措施: Probiotic Supplementation (Dietary Supplement)
Probiotic+diet group
traditional periodontitis treatment + probiotic support + diet
干预措施: Probiotic Supplementation + Personalized Diet (Other)
结局指标
主要结局
Change in Probing Depth (PD) from Baseline to 6 Weeks, measured in millimeters (mm)
时间窗: Baseline and 6 weeks after intervention
Probing depth will be measured at six sites per tooth using a UNC-15 periodontal probe. The mean PD per participant will be calculated, and group-level data will be reported as mean ± standard deviation (SD). PD represents the distance from the gingival margin to the base of the periodontal pocket.
Change in Clinical Attachment Loss (CAL) from Baseline to 6 Weeks, measured in millimeters (mm)
时间窗: Baseline and 6 weeks after intervention
Clinical attachment loss (CAL) will be assessed at six sites per tooth using a UNC-15 periodontal probe. CAL is defined as the distance from the cemento-enamel junction (CEJ) to the bottom of the pocket. The average CAL per participant will be calculated and presented as mean ± SD at the group level.
次要结局
- Change in Nutrient Intake (Protein, Fiber, Sugar, and Carbohydrate) from Baseline to 6 Weeks(Baseline and week 6)
- Correlation Between Nutrient Intake and Periodontal Parameters (PD and CAL) at Week 6(Week 6)
研究者
Feray ÇAĞIRAN YILMAZ
associate professor
Dicle University