A randomized controlled trial comparing the effect of low level laser therapy as an adjunct to scaling and root planing on MMP-8 levels in smoking and nonsmoking patients with chronic periodontitis – A clinico biochemical study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Expecting reduction in Probing Pocket Depth, gain in Clinical Attachment Level and reduction in MMP - 8 levels in gingival crevicular fluid
研究概览
简要总结
Periodontitis is a highly prevalent inflammatory disease in tooth supporting tissues, induced by bacteria growing in a biofilm on tooth surfaces. Conventional periodontal therapy includes surgical and non-surgical approaches that involve instrumentation of inflamed dentogingival complex.
Low level laser therapy (LLLT) has been widely applied in reducing inflammation. Research indicates that LLLT induces an anti-inflammatory effect that may enhance periodontal disease therapy.
Smoking is an independent risk factor for initiation, extent and severity of periodontal disease.
This study is done to evaluate the effect of LLLT as an adjunct to non-surgical periodontal therapy in smoking and nonsmoking patients with chronic periodontitis.
A total of 16 patients including males and females, with chronic periodontitis aged between 30-65 years are included in the study. The proposed study will be explained to each of the selected patients and his/her written consent will be obtained prior to the commencement of the study. The demographic characteristics of the patients (age and sex), clinical parameters will be recorded initially. All the patients in the study will be divided into two groups (Group-A and Group-B) based on their smoking habits. Group-A consists of current smokers (≥10 cigarettes/day) and group-B consists of non-smoker patients. 4 clinical variables will be evaluated at the baseline by one examiner who will be recording all measurements in a single blind design including Plaque Index (PI), Sulcus Bleeding Index (SBI), Probing Pocket depth (PPD), Clinical Attachment Level (CAL).
The study will be done in a split mouth design in both groups, where two quadrants will receive Scaling and Root Planing (SRP) and the other two quadrants will receive LLLT as an adjunct to SRP. LLLT will be done on 1st, 7th and 21st day.
Gingival crevicular fluid will be collected from the deepest periodontal pocket in both SRP and LLLT as an adjunct to SRP sites. GCF samples will be collected using micro-capillary pipettes at baseline, 1st and 3rd month after treatment for assessment of MMP-8 levels. The assessment of MMP-8 levels will be done using Enzyme Linked Immuno Sorbant Assay (ELISA). Clinical parameters will also be recorded at the same time intervals.
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
- •Subjects with chronic periodontitis.
- •Subjects with periodontal pocket ≤10mm.
- •Subjects who are current smokers (≥ 10 cigarettes/day) and nonsmokers.
排除标准
- •Subjects with any systemic disease.
- •Subjects who have undergone any periodontal treatment in the last 6 months.
- •Subjects who have received antibiotics/anti-inflammatory drugs/steroids in the recent past Pregnant or lactating women.
- •Subjects with teeth mobility of grade III.
- •Subjects with periodontal pockets greater than 10mm.
结局指标
主要结局
Expecting reduction in Probing Pocket Depth, gain in Clinical Attachment Level and reduction in MMP - 8 levels in gingival crevicular fluid
时间窗: Baseline, 1 month and 3 months
次要结局
- Gradual reduction of Probing pocket depth, increase in Clinical attachment level and Gradual reduction in MMP - 8 levels.(Baseline, 1 month and 3 months)