Probiotic Therapy as an Adjunct Treatment in Periodontitis Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical parameters (Gingival Index, Plaque Index, Probing Pocket Depth, Clinical Attachment Level)
研究概览
简要总结
| Periodontitis is a chronic inflammatory disease that affects the supporting structures of the teeth, leading to tissue destruction and potential tooth loss. It is a significant public health concern, particularly in individuals with Type 2 diabetes mellitus (T2DM), as diabetes exacerbates the progression of periodontal disease due to impaired immune responses and delayed wound healing.1 |
Diabetic patients often exhibit poor response to conventional periodontal treatments, such as scaling and root planing (SRP), which remain the standard approach for managing periodontitis.2 Despite this, many diabetic patients experience recurrent or persistent periodontal breakdown, necessitating the exploration of adjunctive therapies. In recent years, there has been growing interest in the use of probiotics as a supplementary treatment for periodontal diseases. Probiotics have demonstrated potential benefits in modulating the inflammatory response, improving oral health, and reducing pathogenic bacteria in the oral cavity.3
Several studies have shown that probiotic therapy can help lower inflammatory cytokines, such as interleukin-4, which are implicated in the development of periodontitis.4Additionally, probiotics have been suggested to improve glycemic control in diabetic patients, which may, in turn, enhance periodontal health outcomes.5
The study will evaluate use of adjunct probiotics with SRP on clinical outcomes contributing to evidence supporting probiotics in diabetic periodontal care and improved glycemic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with Type 2 Diabetes Mellitus and HbA1c more than
- •Moderate to severe periodontal disease.
- •Probing depth more than 4mm.
- •Patients who can provide informed consent.
排除标准
- •Pregnancy or lactating women.
- •Patients who have taken antibiotics within last 3 months.
- •Patients with known allergy to probiotics or to tablet contents.
结局指标
主要结局
Clinical parameters (Gingival Index, Plaque Index, Probing Pocket Depth, Clinical Attachment Level)
时间窗: Baseline, 1 month and 3 months
次要结局
- 1) Clinical Parameters - HbA1c and PPBS(2) Microbiological assessment of gram negative pathogens)
研究者
Divya ManojBhai Rathi
Ahmedabad Dental College and Hospital
