Evaluation of Para-Probiotic Toothpaste and Mouthwash on Periodontal Health and Glycemic Control in Diabetic Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in mean Clinical Attachment Level (CAL)
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM).
A total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule.
Clinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2.
The primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction.
This study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Diagnosis of periodontitis (Stage II or III; Grade B or C)
- •Presence of at least one periodontal pocket per side of the mouth, with a maximum of 20 teeth presenting pathological probing depths
- •Presence of both single- and multi-rooted teeth
- •Type 2 diabetes mellitus diagnosed at least one year prior to enrollment
- •Good general health status and ability to comply with study protocol
- •Written informed consent provided
排除标准
- •Presence of cardiac pacemakers
- •History of neurological disorders
- •History of psychiatric disorders
- •Current pregnancy or breastfeeding
- •Steroid-induced diabetes mellitus
- •Inability or unwillingness to attend follow-up visits or adhere to home oral care instructions
研究组 & 干预措施
Para-Probiotic Oral Care Group
Participants receive standard non-surgical periodontal therapy and use para-probiotic toothpaste (Biorepair Plus Parodontogel) and para-probiotic mouthwash (Biorepair Plus), twice daily for 15 days after each recall visit, over a 6-month period.
干预措施: Para-probiotic oral care (Drug)
Chlorhexidine Oral Care Group
Participants receive standard non-surgical periodontal therapy and use toothpaste and mouthwash containing 0.20% chlorhexidine, twice daily for 15 days after each recall visit, over a 6-month period.
干预措施: Chlorhexidine oral care (Drug)
结局指标
主要结局
Change in mean Clinical Attachment Level (CAL)
时间窗: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)
This outcome measures the difference in mean Clinical Attachment Level (CAL) between baseline and the 6-month follow-up in patients with periodontitis and type 2 diabetes mellitus, randomized to receive either para-probiotic-based or chlorhexidine-based oral care after standard non-surgical periodontal therapy. CAL will be assessed in millimeters at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) using a calibrated manual periodontal probe. Measurements will be performed at three predefined timepoints: at baseline (T0, Day 0) before the start of treatment; at three months (T1, approximately Day 90) as an intermediate evaluation; and at six months (T2, approximately Day 180), which represents the final endpoint. The primary endpoint is defined as the difference in mean CAL per patient between the baseline and the 6-month follow-up.
次要结局
- Change in Bleeding on Probing (BoP) score(Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2))
- Change in Probing Pocket Depth (PPD) score(Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2))
- Change in Plaque Index (PI) score(Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2))
- Change in glycated hemoglobin (HbA1c) level(Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2))
- Change in patient satisfaction score(3-month follow-up (T1) and 6-month follow-up (T2))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia