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临床试验/CTRI/2024/08/072049
CTRI/2024/08/072049尚未招募Phase 3 4

A comparative study of ozone therapy and photodynamic therapy as an adjunct to scaling and root planing in chronic periodontitis

Shilpi Mangal1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年8月15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
36
试验地点
1
主要终点
Gingival Index , Plaque Index , Periodontal pocket depth and Clinical attachment level

研究概览

简要总结

The main goal of periodontal therapy is to arrest the inflammatory disease process and allow the regeneration of the lost periodontium. Scaling & root planing is the gold standard non surgical periodontal treatment but not completely eliminate the residual pockets & bacteria , particularly at the furcation , root concavities , interproximal areas & sites with deepest pocket that are inaccessible to periodontal instruments ,  so adjunctive therapies are required .Among the available non surgical therapies to achieve the better plaque control , ozonated water therapy & photodynamic therapies are being widely recognized as two available techniques .The unique properties , non invasive nature , versatility makes both of them as an effective tool in the treatment of periodontitis .Ozone is very effective in antibiotic resistant strains. Adjunctive use of LASERS in non surgical therapy is one of the upcoming potential treatment strategies & antibacterial effect of lasers may be enhanced by the inclusion of a photosensitizing dye, Indocyanine ,exhibiting a 20 % photodynamic effect  & its main action is through photothermal effect.

This study will evaluate & compare the clinical parameters , microbial load & biochemical markers IL-1beta & pentraxin 3  in chronic periodontitis patients of ozone therapy, photodynamic therapy & scaling & root planing at baseline , 1 month & 3 months. The patients of chronic periodontitis will be selected from the Department of Periodontology ,King George Medical University .

After eliglbility checking according to the inclusion & exclusion criteria , patient will be allocated in Group A ,B , C respectively by lottery method. The entire procedure will be explained to the patients & signed informed consent will be obtained .All clinical parameters will be recorded at baseline(first time the patient reports) before scaling & root planing with a standard UNC 15 Probe.

Group A will be only be given full mouth scaling & root planing

Group B will undergo full mouth scaling & root planing along with ozone therapy

Group C will undergo full mouth scaling & root planing along with photodynamic therapy

Deepest pocket site of group B Will be irrigated subgingivally with ozonated water in a concentration of 80 microgram / ml with 22 gauge needle for  5-10 minutes after full mouth scaling and root planing & Group C patient will be delivered Indocyanine dye ,0.05 miligram / ml with 22 gauge needle for 30 seconds & the sites will be exposed to low level laser for 1 minute in non contact continuous wave mode after full mouth scaling & root planing.

For Microbiological assessment , sampling sites first isolated using cotton rolls & supragingival plaque will be removed with the help of sterile cotton pellets , subgingival plaque samples from the maximum pocket depth  will be collected from the sterile curette & transported in an anerobic transport medium & will be cultured on Wilkins Chalgran anerobic agar prepared by the standard protocol & incubated in anerobic gas pack jar ,bacterial identification will be done by Matrix assisted laser desorption ionization time of light (MALDI-TOF MS), biomerieux. Semiquantitative estimation will be done by counting the colony forming units.

For Biochemical marker, GCF sample will be collected with the help of absorbent paper point. Paper point will be inserted into the deepest pocket from 2-3 sites for 30 seconds until resistance  is felt & then placed into the eppendorf tube containing phosphate buffer solution & then analyzed with the help of ELISA Kit according to the manufacture’s instructions.

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 Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Generalized chronic periodontitis patients when equal to or greater than 30 percentage of the sites are affected by the disease , probing depth equal to or greater than 5 mm , clinical attachment level equal to or greater than 4 mm in at least 10 percentage of sites , no gender discrimination.

排除标准

  • Smokers , history of systemic diseases that can alter the course of the periodontal disease , history of periodontal therapy in the last 6 months , history of taking antibiotics or any form of antioxidant therapy within the last 3 months , pregnant women or women in the lactation period , patient who are allergic to photosensitizer dye .

结局指标

主要结局

Gingival Index , Plaque Index , Periodontal pocket depth and Clinical attachment level

时间窗: Baseline,1 month & 3 months

次要结局

  • Microbiological assessment in terms of Colony forming units and Biochemical marker analysis IL-1beta and Pentraxin 3(Baseline , 1 month and 3 months)

研究者

发起方
Shilpi Mangal
申办方类型
Other [Self - Principle investigator]
责任方
Principal Investigator
主要研究者

Shilpi Mangal

King Georges Medical University

研究点 (1)

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