Comparative evaluation of wound healing capacity of Calendula Officinalis with that of platelet rich fibrin (PRF) at the palatal donor site after obtaining free gingival graft. -A Randomized clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Primary outcome:To observe wound closure according to the Healing Index and haemostasis.
研究概览
简要总结
Detailed description of procedure/processe
The study design is in-vivo randomized control clinical trial ÂÂÂÂÂ-Randomization will be done by using computer method. The surgical procedures shall be follows:
The subjects fulfilling the inclusion criteria will be randomized into two groups (Group A & Group B) by computer method.
The subjects will be given the Patient information sheet (PIS) on the first day of visit.
Maxillary impression will be taken using alginate and the cast will be prepared for all the subjects participating in the study, then the acrylic stent will be made.
2ml Local anesthesia 2% lidocaine (adrenaline 1:10000) will be administered at Nasopalatine and Greater palatine on the day of surgery.
Incision will be placed using blade #15 for procurement of the palatal graft. A standard measurement of width and height (1cm x 1cm) graft will be taken from all the patients.
10 ml of blood from antecubital vein of the patient will be collected in the sterile test tube without anticoagulant and will be centrifuged for – 12 min at the centrifugation speed at – 2700 RPM to obtain PRF for the Control Group B.
The patients who are allocated to Test group A- 1% Calendula Officinalis gel will be placed on the palatal wound and Gelatin film will be placed over and suture/glued whereas, Group B will receive Platelet Rich Fibrin (PRF) and Gelatin film will be placed over and sutured/glued.
(The 10% calendula gel will be diluted to 1% calendula by distilled water by the help of Manipal college of pharmacy.) 10% calendula officinalis is readliy available in the market (Fourrts)
Then the stent will be placed in both the groups.
The procured graft then will be used in periodontal surgery according to the patients requirement.ie; to increase the width of attached gingiva, miller class 1 or class 2 recession or Vestibuloplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to participate in the study Patients undergoing plastic surgery and requiring soft tissue graft.
- •Good oral hygiene No history of periodontal surgery at the operation site.
排除标准
- •History of known systemic diseases like hypertension, diabetes, HIV, radiation therapy, immunosuppressive therapy, cancer.
- •Pregnancy/lactation Patients with the habit of smoking and tobacco chewing Medications known to affect the outcomes of the treatment.
结局指标
主要结局
Primary outcome:To observe wound closure according to the Healing Index and haemostasis.
时间窗: 7th day, 15th day and 2 months
Secondary outcome:To record Pain perception using verbal rating scale (VRS)
时间窗: 7th day, 15th day and 2 months
次要结局
- Secondary outcome:To record Pain perception using verbal rating scale (VRS)(7th day, 15th day and 2 months)