跳至主要内容
临床试验/CTRI/2025/03/083180
CTRI/2025/03/083180尚未招募Phase 3 4

Probiotic Therapy as an Adjunct Treatment in Periodontitis Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial

Department of Periodontology Ahmedabad Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月1日最近更新:

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

发起方
Department of Periodontology Ahmedabad Dental College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Divya ManojBhai Rathi

Ahmedabad Dental College and Hospital

研究点 (1)

Loading locations...

相似试验