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临床试验/CTRI/2024/05/066702
CTRI/2024/05/066702已完成2 期

Comparison of efficacy of Phthalocyanine (Pc) and Methylene blue (MB) as photosensitizers in Photodynamic Therapy as an adjunct to Scaling and Root Planing in Chronic Periodontitis A Clinical and Microbiological study

DrSuryakanth Malgikar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月27日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Probing Pocket Depth (PPD)

研究概览

简要总结

The present study is designed to compare the efficacy of two different photosensitizers Phthalocyanine (Pc) and Methylene Blue (MB) in Photodynamic therapy on to reduce the viability of gram-positive and gram-negative pathogens.
MATERIALS AND METHODS:

SOURCE OF DATA:

Subjects with chronic periodontitis aged 18-60 years will be selected from the outpatient department of periodontics, kamineni institute of dental sciences.

INCLUSION CRITERIA:

1.      Age group 18-60 years.

2.      At least 20 teeth present

3.      Bleeding on probing

4.      Chronic periodontitis stage 2 and 3 with grade B

5.      Periodontal Pocket Depth ≥ 5mm.

EXCLUSION CRITERIA:

1.      Systemically compromised patients and those on medications that may interfere with wound healing.

2.      Pregnant women and lactating mother.

3.      Smokers

4.      Active periodontal treatment within the last 6 months

SAMPLE SIZE: The study consists of 30 subjects which will be randomly assigned (ten in each) into three groups.

Group I:  Scaling and root planing (SRP)

Group II: SRP and PDT with phthalocyanine blue (Pc)

Group III: SRP and PDT with 1% methylene blue

CLINICAL PARAMETERS

The following parameters will be assessed at Baseline and after 1 Month.

1.      Plaque index (PI)

2.      Bleeding on probing (BOP)

3.      Probing Pocket Depth (PPD)

4.      Clinical Attachment Level (CAL)

The probing pocket depth and CAL will be measured using a UNC-15 graduated periodontal probe.

MICROBIOLOGICAL PARAMETERS

Subgingival plaque samples will be collected at baseline and at the end of 1 month in a transport media (Saline 0.9%) for estimating the presence of gram-positive and gram-negative pathogens at Kamineni Institute of Medical Sciences, Narketpally.

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, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • At least 20 teeth present
  • Bleeding on probing
  • Chronic periodontitis stage 2 and 3 with grade B
  • Periodontal Pocket Depth ≥ 5mm.

排除标准

  • Systemically compromised patients and those on medications that may interfere with wound healing.
  • Pregnant women and lactating mother.
  • Active periodontal treatment within the last 6 months.

结局指标

主要结局

Probing Pocket Depth (PPD)

时间窗: baseline, 4 weeks and 12 weeks

Clinical Attachment Level (CAL)

时间窗: baseline, 4 weeks and 12 weeks

次要结局

  • microbiological outcome(baseline 1 month 3 months)

研究者

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

Drsuryakanth malgikar

Kamineni Institute of Dental Sciences

研究点 (1)

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