SALIVARY CALPROTECTIN LEVELS IN PERIODONTITIS ASSSOCIATED WITH DIABETES MELLITUS AFTER LOW LEVEL LASER THERAPY AS AN ADJUNT TO SCALING AND ROOT PLANING - A RANDOMISED CLINICAL TRIAL
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Weather salivary calprotectin levels got reduced by using laser along with scaling and root planing and scaling and root planing in type 2 diabetes mellitus patients with periodontitis.
研究概览
简要总结
A randomized clinical trial will be conducted by the Department of Periodontology, Narayana dental college and hospital, Nellore, Andhra Pradesh, India.
Participants aged 30 - 60 years based on inclusion and exclusion criteria were selected from the department of periodontology Narayana dental hospital Nellore before the commencement of the study.
All the participants will be explained about the aim, nature, and design of the study along with the written informed consent for their participation before the commencement of the study.
An assessment of PPD, CAL, BI (Muhlemann & Son), PI (silness and loe) was done using UNC-15 probes Hu-friedy’s. Patients will be grouped into
Group A: Participants with periodontitis alone
Group B: Participants with periodontitis and with type II diabetes
Group A1: Participants of group A receiving SRP (Scaling & root planning) alone
Group A2: Participants of group A receiving SRP + LLLT (Low-Level Laser Therapy)
Group B1: Participants of group B receiving SRP (Scaling & root planning) alone
Group B2: Participants of group B receiving SRP + LLLT (Low-Level Laser Therapy)
Scaling and root planing is performed under local anesthesia by ultrasonic scalers in all groups, followed by low-energy-level diode laser(630-670nm) was applied externally with light contact to the gingival tissues corresponding to pockets in apico-coronal direction for 15s per site, scanning both lingual and buccal side in group A2 and group B2. Oral hygiene instructions were given to participants.
Three milliliters of unstimulated whole expectorated saliva will be collected from each participant into sterile 5ml saliva collecting tubes and samples was stored at -80 degree centigrade.
Participants will be recalled after 8 weeks, saliva is collected in sterile 5ml collecting tube and stored at -80 degree centigrade and calprotectin levels will be determined by ELISA technique
All the parameters will be subjected for statistical analysis after completion of the study to evaluate and compare.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •periodontitis with a probing pocket depth(PPD) ≥5 mm, clinical attachment level (CAL)≥ 2mm.
- •patients with periodontitis and diabetes.
排除标准
- •Participants taking medication from past 3 months excluding diabetes medications were excluded from the study Pregnancy, lactating women Patients underwent surgical or nonsurgical therapy within 6 months prior to the study.
- •Patients with any autoimmune disorders (such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, psoriasis, refractory asthma) Patients with oro-mucosal abnormalities Patients with the usage of tobacco and alcohol in any form.
结局指标
主要结局
Weather salivary calprotectin levels got reduced by using laser along with scaling and root planing and scaling and root planing in type 2 diabetes mellitus patients with periodontitis.
时间窗: baseline and 8th week
次要结局
- to asses clinical parameters following laser therapy as an adjunct to scaling and root planing(baseline and 8th week)