Comparative evaluation of the efficacy of the titanium platelet rich fibrin and choukrouns platelet rich fibrin in bilaterally impacted mandibular third molar surgery - A split mouth study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess pain, swelling,mouth opening,wound healing, bone formation
研究概览
简要总结
1. After obtaining approval and clearance from the institutional ethical committee, the patients fulfilling the inclusion criteria will be taken up for the study after obtaining informed consent.
2. Patients with bilaterally symmetrically impacted mandibular third molar, which requires an extraction for prophylactic reasons will be selected for the study and randomly assigned to one of the two groups.
3. 10 ml of blood will be drawn from the antecubital vein and transferred into sterile medical grade titanium tubes for group 1 and sterile glass tubes for group 2 respectively.
4. Centrifugation will be carried out at 2800 RPM for 12 minutes for T-PRF and 2700 RPM for 12 min for L-PRF and due to the difference in densities three layers will be formed. The top layer will be pipetted out with a sterile dropper which consists of acellular plasma .The bottom layer will be the red cell layer, and the middle layer will consist of T-PRF or L-PRF.
These T- & L-PRF clots are retrieved from titanium and glass tubes using a sterile tweezer and placed on a sterile gauze.
5. surgical extraction of bilateral impacted mandibular third molars to be done at different intervals. (Minimum of 1 week )
6. Surgical extraction of impacted molar will be performed after achieving profound anaesthesia with 2% lignocaine hydrochloride with 1:80,000 adrenaline.
7. The extraction socket will be thoroughly debrided and irrigated with copious saline and betadine irrigation.
8. After the defect is thoroughly evaluated. In group I cases, the T-PRF will be utilized, and in group II cases, the L-PRF will be utilized to fill the extraction socket followed by primary closure.
9. Patients will be recalled on 3rd day, 7th day ,1st month and 6th month.
10. Following parameters will be assessed:
· Pain (visual analogue scale)
· swelling
· Healing index (Landry et al)
· Inter incisal measurement.
· Radiographic evaluation for bone formation will be assessed using IOPAR with grid
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group between 18 TO 60 who fall in ASA 1 and 2 categories.
排除标准
- •PATIENTS WITH LOCALIZED INFECTION IN MANDIBULAR THIRD MOLARS PATIENTS WITH ANY MAJOR SYSTEMIC ILLNESS WHO FALL INTO ASA 3 AND 4 PATIENTS WITH HISTORY OF ALLERGIES TOWARDS TITANIUM PATIENTS TAKING MEDICATIONS AFFECTING WOUND HEALING PATIENTS WITH REDUCED PLATELET COUNT LESS THAN 2 LAKH PER MIL PREGNANT OR LACTATING WOMEN SMOKERS PATIENT WITH PSYCHIATRIC ILLNESS.
结局指标
主要结局
To assess pain, swelling,mouth opening,wound healing, bone formation
时间窗: first day, third day, seventh day, first month and sixth month.
次要结局
未报告次要终点
研究者
Dr. Poorvika S D
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL