跳至主要内容
临床试验/CTRI/2022/11/046988
CTRI/2022/11/046988已完成3 期

ROLE OF PHOTODYNAMIC THERAPY AS AN ADJUNCT TO SCALING AND ROOT PLANING IN CHRONIC PERIODONTITIS PATIENTS WITH TYPE 2 DIABETES MELLITUS: A PILOT RANDOMIZED CONTROL TRIAL

Sumita Manandhar1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年4月10日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
To assess post treatment changes in Probing depth, Clinical Attachment loss, Bleeding on Probing , Plaque Index ,HbA1c levels, TNF-α

研究概览

简要总结

Periodontitis is a chronic inflammatory disease characterized by periodontal destruction and is the sixth complication of diabetes. Patients with periodontal disease and diabetes have hyperinflammatory immune cells that elevate proinflammatory cytokines resulting in periodontal destruction. Photodynamic therapy (PDT) involves the use of photosensitizer dye, a low-level diode laser of a specific wavelength which gets activated and releases free radicals that are specific to target cells. Advantages of PDT are its specificity to cells, no lateral damage, and lack of development of resistant bacterial species. The aim of this study is to describe the role of PDT on periodontal status, immunological parameters and diabetic control of chronic periodontitis patients with type 2 diabetes when used as an adjunct to scaling and root planing. The study is a pilot study with 15 patients on each arm; however,17 patients will be selected for loss to follow-up. Patients fulfilling the inclusion and exclusion criteria will be selected and patients will be randomly divided using block randomization into test and control groups after taking consent. The test group will receive additional photodynamic therapy as an adjunct to scaling and root planing and parameters will be recorded like clinical (probing depth, clinical attachment loss, bleeding on probing, plaque index), Hba1c levels, TNF-@ levels at baseline and after 3 months post-treatment.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Confirmed diagnosis of type 2 diabetes, Glycated haemoglobin (HbA1c) values more than 7% and no more than 10% taken 3 months prior to selection in the study, Patients diagnosed with a case of generalized moderate to severe chronic periodontitis, Patients with at least 20 remaining teeth, Willing to comply with the study-related procedures.

排除标准

  • Pregnant and lactating women, Smokers,Patients with uncontrolled diabetes mellitus even after medications, Patients who received periodontal treatment or antibiotic therapy last 6 months, Patients allergic to photosensitizer dye, Refusal or inability to give informed consent.

结局指标

主要结局

To assess post treatment changes in Probing depth, Clinical Attachment loss, Bleeding on Probing , Plaque Index ,HbA1c levels, TNF-α

时间窗: Baseline and 3 months

次要结局

  • To assess post treatment changes of Bleeding on Probing , Plaque Index HbA1c levels, TNF-α(Baseline and 3 months)

研究者

发起方
Sumita Manandhar
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验