Subgingival Lactobacillus Reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Diabetic Patients (LREUTERI-DM)
Effect of Adjunctive Subgingival Lactobacillus Reuteri in Non-Surgical Periodontal Therapy for Periodontitis in Patients With Diabetes: A Randomized Controlled Clinical Trial
研究概览
详细说明
Periodontitis is a chronic inflammatory disease associated with dysbiotic subgingival biofilms and is strongly influenced by diabetes mellitus. Chronic hyperglycemia may impair immune function and wound healing, resulting in increased periodontal destruction and poorer treatment outcomes. Non-surgical periodontal therapy based on scaling and root planing (SRP) remains the standard treatment; however, residual periodontal pockets may persist after therapy.
Lactobacillus reuteri probiotics have demonstrated antimicrobial, anti-inflammatory, and host-modulatory properties and may enhance periodontal healing. This randomized controlled clinical trial evaluated the adjunctive effects of subgingival administration of a liquid probiotic preparation containing Lactobacillus reuteri in diabetic patients with Stage III Grade B or higher periodontitis.
Forty periodontal sites were randomly allocated to either a test group receiving SRP plus subgingival Lactobacillus reuteri probiotics or a control group receiving SRP plus saline irrigation. A second application was performed at the 1-month visit. Clinical outcomes included plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level. Glycemic control was evaluated using HbA1c levels, and microbiological analysis was performed using real-time PCR for Porphyromonas gingivalis, Tannerella forsythia, and Fusobacterium nucleatum.
Assessments were conducted at baseline, 1 month, and 3 months. The primary objective was to evaluate changes in clinical outcomes. Secondary objectives included microbiological and glycemic outcomes.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ho Chi Minh City
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Ho Chi Minh City、Ho Chi Minh City、越南、700000
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age ≥18 years.
- Diagnosed with diabetes mellitus according to WHO criteria.
- Stage III Grade B periodontitis or higher according to the 2017 AAP/EFP classification.
- At least 15 remaining teeth.
- Periodontal pockets ≥5 mm with bleeding on probing.
- Clinical attachment loss ≥5 mm.
Exclusion Criteria:
- Current smokers.
- Pregnant or lactating women.
- Use of antibiotics or anti-inflammatory medications within 1 month before enrollment.
- Periodontal therapy within the previous 3 months.
- Undergoing orthodontic treatment.
- Presence of pulpal lesions or severe occlusal trauma.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:SRP + Lactobacillus reuteri
Subgingival Lactobacillus reuteri
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Subgingival administration of liquid Lactobacillus reuteri following scaling and root planing.
The probiotic solution was applied into periodontal pockets at baseline and re-applied after 1 month.
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有源比较器:SRP + Saline
Saline Control
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Subgingival administration of sterile saline solution following scaling and root planing.
Saline was applied into periodontal pockets at baseline and re-applied after 1 month using the same protocol as the test intervention.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Bleeding on Probing (BOP)
大体时间:Baseline to 3 months
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Bleeding on probing was assessed at baseline, 1 month, and 3 months after treatment.
Changes in the percentage of bleeding sites were used to evaluate periodontal inflammation.
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Baseline to 3 months
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Change in Probing Pocket Depth (PPD)
大体时间:Baseline to 3 months.
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Probing pocket depth was measured using a UNC-15 periodontal probe at baseline, 1 month, and 3 months after treatment.
The primary outcome was the change in PPD from baseline to 3 months.
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Baseline to 3 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Clinical Attachment Level (CAL)
大体时间:Baseline to 3 months.
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Clinical attachment level (CAL) was measured using a UNC-15 periodontal probe.
Changes in CAL was assessed to evaluate periodontal attachment gain following treatment.
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Baseline to 3 months.
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Changes in Glycated Hemoglobin (HbA1c)
大体时间:Baseline, 1 month, and 3 months
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HbA1c levels were assessed at baseline, 1 month, and 3 months following treatment to evaluate glycemic control.
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Baseline, 1 month, and 3 months
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Changes in Subgingival Periodontal Pathogens
大体时间:Baseline to 3 months
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Quantitative levels of Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium nucleatum were assessed using microbiological analysis.
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Baseline to 3 months
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合作者和调查者
调查人员
- 学习椅:Thu Nguyen Ngoc Yen, PhD、Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- THS-PERIO-2026-01
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IPD 计划说明
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