A clinico biochemical study to evaluate the efficacy of collagen peptide supplements with an intervention of nonsurgical periodontal therapy and on salivary nitric oxide level in chronic periodontitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Decrease in periodontal probing depth and clinical attachment loss
研究概览
简要总结
The primary objective of my clinical trial is "Can collagen peptide supplement enhance the effect of non-surgical periodontal therapy and decrease the level of salivary nitric oxide in chronic periodontitis patients?"
METHODOLOGY****Study design:
The present study is a double blind, parallel group, clinico-biochemical, randomised controlled trial with a 2-months period.
Group A: 23 Chronic periodontitis patients with collagen peptide supplement as an adjunct to scaling and root planing and salivary nitric oxide level.
Group B: 23 Chronic periodontitis patients with scaling and root planing alone and salivary nitric oxide level.
Study setting:
Subjects with chronic mild to moderate periodontitis will be selected for the study from the out-patient department, Department of Periodontology.
Sample size:
A sample size of minimum 46 patients (Group A= 23 and Group B= 23) is selected for the study.
Clinical procedure: 1st visit: baseline
1. Informed consent from the subject will be obtained.
2. At 1st visit, detailed medical, dental histories as well as periodontal examination will be recorded and patients fulfilling the inclusion criteria will be included in the study.
3. Unstimulated saliva samples will be taken to evaluate the salivary nitric oxide level.
4. Thorough scaling and root planing will be done for all patients.
5. Test group patients will be given hydrolyzed collagen peptide powder sachets of 5g/day for two months that should be taken in water half an hour before meal (lunch).
Nitric oxide level in saliva:
Salivary estimation of NO will be carried out using the Griess colorimetric reaction in the laboratory.
2nd visit: 4 weeks
Follow up and evaluation of clinical parameters.
3rd visit: 8 weeks
Follow up and evaluation of clinical parameters.
Unstimulated saliva sample collection to re-evaluate salivary nitric oxide level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Minimum 20 natural teeth Diagnosis: Chronic mild to moderate periodontitis Probing depth: 3-7mm Clinical Attachment Loss: 2-4mm Bleeding on probing Systemically healthy patients Patient agreed to give the consent only are included.
排除标准
- •Tobacco-smokers, electronic cigarette users, smokeless tobacco product users, alcohol users.
- •Individuals that had used antibiotics and/or steroids within the past 3-month.
- •Individuals with any systemic diseases.
- •Lactating and/or pregnant females.
- •Completely edentulous individuals.
结局指标
主要结局
Decrease in periodontal probing depth and clinical attachment loss
时间窗: Baseline | Four weeks | Eight weeks
次要结局
- Decrease in the level of salivary nitric oxide
研究者
Yogita Kshirsagar
Yogita Dental College and Hospital