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
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
Drsuryakanth malgikar
Kamineni Institute of Dental Sciences
