跳至主要内容
临床试验/CTRI/2024/12/077954
CTRI/2024/12/077954尚未招募不适用

Clinical Effectiveness of laser Therapy as an adjunct to non-surgical periodontal treatment in subjects with Chronic Periodontitis: A randomized clinical study

Dr Santosh Kumar verma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月1日最近更新:

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)

研究者

发起方
Dr Santosh Kumar verma
申办方类型
Other [silf]

研究点 (1)

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