Evaluation and comparison of Semaphorin 4D (SEMA4D) levels in saliva of periodontally healthy and Stage 1 Grade A periodontitis patients and its response to non-surgical periodontal treatment: A clinico-biochemical interventional study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.To determine the level of SEMA4D in saliva of periodontally healthy patients.
研究概览
简要总结
This is a clinico-biochemical interventional study to compare the level of Semaphorin 4D (SEMA4D) levels in saliva of periodontallyhealthy and Stage 1 Grade A periodontitis patients and its response tonon-surgical periodontal treatment.
Based on theclinical parameters subjects will be categorized into two groups.
• GroupI (Periodontally Healthy) consisting of 25 subjects with clinically healthyperiodontium and no evidence of disease (GI = 0; PI=0, CAL =0).
• GroupII (Stage 1 Grade A periodontitis) consisting of 25 subjects with Stage 1 Grade A periodontitis (GI ≥1; PPD >3 mm, CAL >1mm).
• GroupIII (Stage 1 Grade A periodontitis) subjects of group II who willundergo scaling and root planing and will be re-evaluated after 4 weeks tore-determine the level of SEMA 4D in saliva.
The data obtained will be entered into Microsoft excel spread sheet and will be further analyzed with the help of SPSS software (version 17.0, IBM, USA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals with good general health and age between 18-60 years.
- •Subjects who have not received periodontal therapy, in the previous six months.
- •Subjects who readily give informed consent for the study.
- •Systemically healthy patients.
- •Subjects with gingival index 0, plaque index 0, clinical attachment level 0 will be included as periodontally healthy.
- •Subjects with gingival index greater then or equal to 1, pocket probing depth less then or equal to 4mm, mostly horizontal bone loss, clinical attachment level 1-2 mm affecting less then or equal to30% teeth involved with radiographic bone loss extending to the coronal-third and no teeth loss due to periodontitis will be included as Stage 1 grade A periodontitis.
排除标准
- •Consumption of tobacco in any form and alcoholics.
- •Pregnant and lactating females.
- •Subjects who have received anti-inflammatory, antibiotic and steroid drugs in previous three months.
结局指标
主要结局
1.To determine the level of SEMA4D in saliva of periodontally healthy patients.
时间窗: At baseline and at 4 weeks
2.To determine the level of SEMA4D in saliva of Stage 1 Grade A periodontitis.
时间窗: At baseline and at 4 weeks
3.To compare the level of SEMA4D in saliva of periodontally healthy and Stage 1 Grade A periodontitis.
时间窗: At baseline and at 4 weeks
4.To compare salivary levels of Semaphorin 4D (SEMA4D) before and after scaling and root planing in Stage 1 Grade A periodontitis patients.
时间窗: At baseline and at 4 weeks
次要结局
- 1.To correlate salivary levels of Semaphorin 4D (SEMA4D) with clinical parameters like Plaque Index (PI), Gingival Index (GI),Probing Depth (PD), Clinical Attachment Level (CAL) and Bleeding on Probing (BOP).(At baseline and at 4 weeks)