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临床试验/CTRI/2024/07/070096
CTRI/2024/07/070096尚未招募2 期

Effect of diode laser application as an adjunct to non-surgical periodontal therapy on the reduction of red complex microorganisms in type 2 diabetic patients.

Sherina Iqbal1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年7月22日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
Reduction of red complex bacteria and periodontal parameters in the management of stage 2 periodontitis in type 2 diabetics patients

研究概览

简要总结

It will be a split mouth longitudinal  clinical study involving subjects with periodontal pocket depth 5-6 mm atleat two teeth.Subjects will receive full mouth ultrasonic supragingival scaling at first visit .The clinical parameters ,gingival index, plaque index ,probing pocket depth and clinical attachment level will be assessed at baseline ,2 weeks and 3 months. The sample collection for microbiological analysis will be done at 2 weeks and 3 months..After 2 weeks of recall ,plaque sample collection and reassessment of the clinical parameters will be done . A full mouth subgingival scaling followed by diode laser application on the test site ll be done in the same visit. The patient is recalled at the end of 3 months the clinical parameters are reassessed and plaque samples are again collected for microbiological analysis. The red complex bacterial count will  be estimated for both study group using RT-PCR.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
35.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Stage 2 periodontitis patients with minimum of two sites have a probing pocket depth of 5mm in stleast two quadrants Type 2 diabetic patients for aleast 2 year Presence of st least 20 teeth in the mouth Non smokers.

排除标准

  • Systemic disease that could affect periodontal treatment outcomes other than type 2 diabetic History of major diabetic complication History of any treatment for periodontal disease in the past 6 months Use of any antibiotic or anti inflammatory drugs in the last 6 months Pregnant or breastfeeding individuals.

结局指标

主要结局

Reduction of red complex bacteria and periodontal parameters in the management of stage 2 periodontitis in type 2 diabetics patients

时间窗: Baseline , 2 weeks , After 3Months

次要结局

  • Estimation of probing pocket depth,clinical attachment level ,gingival index,plaque index(Estimation of microbial load in periodontal pocket)

研究者

发起方
Sherina Iqbal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sherina Iqbal

Mar Baselios Dental College

研究点 (1)

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