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临床试验/CTRI/2023/12/060526
CTRI/2023/12/060526尚未招募Phase 3 4

Evaluation of the efficacy of Liquorice gel as an adjunct to non-surgical periodontal therapy in chronic periodontitis:A randomized control, clinico-microbial trial.

Dr Vaishnavi Shah1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月2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
30
试验地点
1
主要终点
Clinical attachment loss, Probing Depth, Microbial count

研究概览

简要总结

THE STUDY WILL BE CONDUCTED TO COMPARE THE EFFICECY OF PREPARED LIQUORICE GEL IN CHRONIC PERIODONTITIS PATIENTS WITH SHALLOW POCKET DEPTH OF 4-6 mm ADJUNCT TO SCALING AND ROOT PLANING WIYH ONLY SCALING AND ROOT PLANING.

Total sample size is 30 , 15  in each group(test group and control group) . The study span is of 3 months.

At baseline a detailed intra -oral recordings and  complete scaling and root planing will be done in test group and in control group local drug Liquorice gel will be delivered in th subgingival pockets after scaling and root planing.Microbial samples will be taken to evaluate the anaerobic organisms count.

At 1 month recall period clinical records and microbial samples will be  taken.

At 2month recall period clinical records and microbial samples will be  taken.

Microbial organisms P.gingivalis,A.actinomycecomitans,F.nucleatum amd P.intermedia will assessed to check the efficacy of Liquorice gel as these are the main pathogenic organisms of periodontitis.

At the end of the study a  between the test group and control group will be evaluated to check the  efficacy of Liquorice gel as local drug delivery.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.A minimum of 20 natural teeth present 3.Healthy patients diagnosed with chronic periodontitis.
  • Patients having pocket probing depth of 4-6 mm.

排除标准

  • 1.Tobacco-smokers, electronic cigarette users, smokeless tobacco product users, alcohol users.
  • 2.Individuals that had used antibiotics, probiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 3-month.
  • 3.Individuals with systemic diseases (such as cardiovascular diseases,diabetes,, renal disorders, hepatic disorders and/or acquired immune deficiency syndrome/HIV.) 4.Lactating and/or pregnant females.
  • 5.Third molars and fractured teeth with embedded root remnants.
  • 6.Completely edentulous individuals.

结局指标

主要结局

Clinical attachment loss, Probing Depth, Microbial count

时间窗: Baseline , 1 month , 3 month

次要结局

  • Plaque index , Sulcus Bleeding Index(Baseline , 1 month , 3 month)

研究者

发起方
Dr Vaishnavi Shah
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Vaishnavi Sanjay Shah

Yogita Dental College and Hospital , Khed

研究点 (1)

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