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临床试验/CTRI/2019/12/022223
CTRI/2019/12/022223尚未招募1 期

A RANDOMIZED CONTROL TRIAL COMPARING THE EFFICACY OF MINOCYCLINE AS LOCAL DRUG DELIVERY AND DIODE LASER DEBRIDEMENT ON THE LEVELS OF PORPHYROMONAS GINGIVALIS IN CHRONIC PERIODONTITIS:A CLINICO MICROBIOLOGICAL STUDY

Dr Sneha Fal Dessai1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年7月12日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
Expecting reduction in the number of levels of Porphyromonas Gingivalis along with reduction in Sulcus Bleeding Index,Plaque Index,Probing Pocket depth and Clinical Attachment Levels.

研究概览

简要总结

Chronic periodontitis is aninfectious disease resulting in inflammation within the supporting tissues ofthe teeth, progressive attachment loss, and bone loss.The role of Porphyromonasgingivalis is well established in the development and pathogenesis ofperiodontitis.Minocycline acts by interfering withprotein synthesis in the bacterial cell wall along with its anti-collagenaseeffect.Diode laser accelerates woundhealing, promotes angiogenesis and also augments growth factor release.

ThisRandomized Clinical Trial protocol is designed as a split mouth single maskedclinical trial of 12 weeks duration simulating the treatment flow ofconventional periodontal therapy. After qualifying for the study, 15 patientsage ranging from 30-65 years will be enrolled and 4 clinical variables alongwith the microbiological samples will be evaluated at the baseline by oneexaminer who will be recording all measurements in a single blind design. This will include Sulcus Bleeding Index (SBI)PlaqueIndex (PI), Probing Pocket depth (PPD), Clinical Attachment Level (CAL)along with subgingival plaque samples for Porphyromonas Gingivalis. Full mouth scaling and root planing will beperformed at baseline appointment following initial examination.Onequadrant will receive the diode laser therapy on the 1st, 3rd andthe 7th day after scaling and root planing. The other will receiveminocycline gel application after scaling and root planing and the gelapplication will be repeated at two and four weeks in the test sites, accordingto the manufacturer’s instructions.Subgingival plaque samples will be collected atbaseline, and at three month intervals. Sterile periodontal curette will beused for collection of subgingival plaque samples.Forsample collection the teeth surfaces will be dried with sterile gauze to avoidcontamination by saliva. Sub gingival plaque samples will be collected from deepestperiodontal pockets using sterile periodontal curette and assessed for themicrobial load using Polymerase chain reaction

This study is done to compare theefficacy of minocycline as local drug delivery and diode laser debridement andalso to evaluate the levels of Porphromonasgingivalisin chronic periodontitispatients.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc

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 probing depth of greater than 4mm Patients suffering from chronic periodontitis without any medical history.
  • No history of smoking No periodontal treatment within the previous 6 month.

排除标准

  • Pregnant ladies, lactating mothers were excluded from the study.
  • Patients on anti-inflammatory and steroid therapy within the last three months.
  • History of any systemic diseases.
  • Use of hormonal contraceptives.

结局指标

主要结局

Expecting reduction in the number of levels of Porphyromonas Gingivalis along with reduction in Sulcus Bleeding Index,Plaque Index,Probing Pocket depth and Clinical Attachment Levels.

时间窗: Baseline and Three Months

次要结局

  • Gradual reduction in the number of levels of Porphyromonas Gingivalis along with reduction in Sulcus Bleeding Index,Plaque Index,Probing Pocket depth and Clinical Attachment Levels.(Baseline and Three months)

研究者

发起方
Dr Sneha Fal Dessai
申办方类型
Other [self]

研究点 (1)

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