Evaluation of intra pocket anesthetic gels in pain control during scaling and root planing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual analogue scale (VAS)
研究概览
简要总结
AIM:The aim of the study is to evaluate and Compare the effectiveness of Lignocaine and Benzocaine anesthetic gels as intra pocket anesthesia in the treatment of scaling and root planing.
All the participants were explained about the aim,nature,and design of the study along with written informed consent for their participation before the commencement of the study.
The study is planned as randomized clinical trial conducted in healthy individuals with periodontitis.The study duration is 9-12 months in which all clinical parameters- Probing pocket depth(PPD),Modified sulcular bleeding index (mSBI),Gingival index(GI) and Visual analogue scale(VAS),Verbal rating scale (VRS) will be recorded at baseline.
All the patients included in the study will be evaluated before the treatment procedure and patients with periodontitis selected.
Two sites left and right halves of the mandibular/maxillary arch will be selected and assigned as test and control group by flipping a coin.
Test group:2% Lignocaine intrapocket anesthetic gel application
Control group:20% Benzocaine intrapocket anesthetic gel application
Procedure:A split mouth design will be followed,where the bilateral quadrants with periodontal pockets will be chosen, 60 sites from 30 patients will be selected and grouped as test and control site.
The test site will receive topical 2% Lignocaine gel subgingivally and control site will receive 20%Benzocaine gel subgingivally in the pocket using a blunt applicator followed by the two sites (test/control) will be subjected to scaling and root planing. After completion, the patient will be asked to fill the pain assessment scales Visual analogue scale (VAS) and Verbal rating scale (VRS) for root planing in the respective quadrant/sextant.
All the patients will be recalled again after 1 month for re-evaluation of clinical parameters-Probing pocket depth(PPD),Modified sulcular bleeding index (mSBI),Gingival index(GI) in both test and control groups.
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 Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient’s age: 30-50 years.
- •Systemically healthy subjects Presence of at least 4 sites with probing depth ≥5 mm per quadrant.
- •Patients who had not undergone any periodontal therapy in the past 6months.
排除标准
- •Patients requiring prophylactic antibiotics before periodontal probing.
- •Patients Suffering from any mental disorders or with any chronic pain problems.
- •Patients suffering with coagulation/bleeding disorders or on anticoagulants, Pregnant or lactating women.
- •Patients reporting hypersensitivity to lignocaine,Benzocaine.
结局指标
主要结局
Visual analogue scale (VAS)
时间窗: BASELINE.
Verbal Rating Scale(VRS)
时间窗: BASELINE.
次要结局
- Probing pocket depth(PPD).(Modified sulcular bleeding index (mSBI).)