Comparative evaluation of Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.
研究概览
简要总结
Study is conducted to evaluate and compare the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.
Group I: 20 Periodontally Healthy patients.
Group II: 20Non -Smoker Patients with stage III periodontitis.
Group III: 20Smoker Patients with stage III periodontitis.
The primary outcome will be to evaluate the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.
The secondary outcome will be to evaluate and compare the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.
A brief description of entire procedure will be given to every patient before starting procedure. Written informed consent will be taken from the patients who wish to enroll in the study.
Samples of Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy will be collected. Clinical and biochemical parameters will then be evaluated.
METHODS OF MEASUREMENT
Biochemical parameters:
Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels will be measured using Enzyme Linked Immunosorbent Assay (ELISA) kits.
For all participants following periodontal parameters will be recorded:
1. Gingival index (Loe and Silness 1963)
2. Plaque index (Silness and Loe 1964)
3. Papillary bleeding index (PBI) *(*Muhlemann H.R. 1977)
4. Probing pocket depth (PPD)
5. Clinical attachment level (CAL)
After clinical examination, Gingival Crevicular fluid samples would be collected and Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 levels will be evaluated using Enzyme Linked Immunosorbent Assay kit.
Non-surgical periodontal therapy will be performed at baseline at after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Group I: Periodontally healthy patients.
- •Group II: Non-Smoker patients with untreated stage III periodontitis, with PPD more than equal to 5 mm and CAL more than equal to 4mm, BOP at >50% of sites (full mouth) and radiographic evidence of interproximal bone loss.
- •Group III: Smoker patients with untreated stage III periodontitis, with PPD more than equal to 5 mm and CAL more than equal to 4mm, BOP at >50% of sites (full mouth) and radiographic evidence of interproximal bone loss.
排除标准
- •1.Patients who had received periodontal treatment within the last 6 months.
- •2.Patients with any systemic diseases.
- •3.Patients who had or are on immunosuppressive chemotherapy.
- •4.Use of antibiotics within the last 6 months and anti-inflammatory drugs within the last 3 months.
- •5.Pregnant and lactating females.
结局指标
主要结局
To evaluate the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.
时间窗: 18 months
次要结局
- To evaluate and compare the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.(18 months)