Clinical Effectiveness of laser Therapy as an adjunct to non-surgical periodontal treatment in subjects with Chronic Periodontitis: A randomized clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. periodontal pocket depth
研究概览
简要总结
Background: Periodontitis is a chronic inflammatory disease that affects the supporting structures of teeth, resulting in tooth loss. Nonsurgical and surgical therapies along with local and systemic antibiotic regimens have been advocated in the treatment of periodontitis. Aim: The aim of this split-mouth, double-blind, controlled clinical study is to evaluate and compare the effect of scaling and root planing alone and a combination of scaling and root planing (SRP) with diode laser therapy in patients with chronic periodontitis.
Settings and Design: 30 patients with chronic periodontitis were taken from the department of periodontology and implantology, Dental College, RIMS.
Materials and Methods: It is a split-mouth study and subjects will be divided into Group I – the test group (SRP + diode laser) and Group II – the control group (SRP alone). A low-level diode laser with a wavelength of 810 nm, power output 0.4 W, and energy density of 2 J/cm2 & 4 J/cm2 was applied to the gingival pocket. The following clinical parameters were assessed: oral hygiene index simplified; clinical attachment level (CAL); probing pocket depth (PPD); bleeding on probing (BOP) at baseline, 1 month, and 3 months after the treatment.
Result: The data will be analyzed using Statistical Package for Social Sciences (SPSS) version 21. All the variables are continuous variables which will be summarized as mean and standard deviation. A paired t-test will be used for comparison of the mean value of 2 related samples or groups. Repeated measures of ANOVA test will be used to compare more than two related means. The level of statistical significance was set at 0.05.
Keywords: Chronic Periodontitis, Gingival inflammation, Scaling and root planning, Low-level laser therapy, Non-surgical periodontal treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Systemically healthysubjects with at least 20 natural teeth 2.Age group-18 years to 65 years with chronic periodontitis 3.Who have not received any treatment in last six months.
- •4.the presence of at least two bilateral premolars with ≥5-mm periodontal pocket depth (PPD).
- •5.Patients willing to participate in study.
排除标准
- •1.patients with systemic disease, pregnant women or lactating mothers 2.Smokers 3.Use of antibiotics, analgesics, or any other medication within six months of study 4.Patients not willing to participate in the study.
结局指标
主要结局
1. periodontal pocket depth
时间窗: 0,1,3 months
2. bleeding on probing
时间窗: 0,1,3 months
次要结局
- clinical attachment level(0,1,3 months)
