A comparative evaluation of antimicrobial photodynamic therapy vs low level laser therapy as an adjunct to non-surgical periodontal treatment on periodontal parameters in type II diabetics: A RCT
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Reduction in probing depth
研究概览
简要总结
Study aims to investigate and compare the effects of Antimicrobial photodynamic therapy with indocyanine green versus Low level laser therapy as an adjunct to scaling and root planing on periodontal clinical parameters in Type II Diabetics.
OBJECTIVES:
ØTo evaluate the efficacy of antimicrobial photodynamic therapy with indocyanine green as an adjunct to scaling and root planing on periodontal clinical parameters.
ØTo evaluate the efficacy of low level laser therapy as an adjunct to scaling and root planing on periodontal clinical parameters
ØTo compare the outcomes and evaluate if antimicrobial photodynamic therapy or low level laser therapy has an added advantage to mechanical therapy based on clinical parameters at 3 and 6 months follow up.
Group A: Scaling & root planing (SRP) (n=25)
Group B: SRP+ aPDT (n=25)
Group C: SRP+ LLLT (n=25)
ØA total of 4 sessions of aPDT and LLLT procedure will be administered to individuals at 7-day intervals.
ØThe clinical measurements of the patients will be taken at baseline, 3 months and 6 months after the procedures.
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients with chronic periodontitis Age Group- 30-65 years Patients with clinical diagnosis of Type II Diabetes mellitus HbA1c levels ranging from 6.0-8.4% A minimum of 20 teeth present Presence of at least one/two sites with probing pocket depth (PPD) of 5-6mm.
排除标准
- •Periodontal mechanical therapy in previous 6 months.
- •History of antibiotic intake at least 3 months prior Diabetic complications Pregnancy or lactation Smokers or tobacco users Patients with unknown allergy or hypersensitivity reactions Systemic condition other than diabetes that could affect the outcome of treatment.
结局指标
主要结局
Reduction in probing depth
时间窗: Baseline, 3 months and 6 months
次要结局
- Reduction in Plaque Index (PI)(Baseline, 3 months and 6 months)
- Reduction in Gingival Index (GI)(Baseline, 3 months and 6 months)
- Gain in Clinical Attachment Level(CAL)(Baseline, 3 months and 6 months)
- Reduction in Modified sulcular bleeding index (mSBI)(Baseline, 3 months and 6 months)
研究者
Mahima
Goa Dental College and Hospital