Use of autologous partially demineralized dentinal matrix (PDDM) with novel injectable platelet-rich fibrin (i-PRF) for bone grafting after impacted mandibular third molar surgery– A randomized clinical trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To measure the relative bone density in the surgical site
研究概览
简要总结
Aims and Objectives:
This study aims to assess the bone regeneration potential of PDDM + novel i-PRF when used in 3rd molar extraction sites. .
Material and Methods:
Ethical approval will be obtained before the study is stated. All the procedures will be done in adherence with the Declaration of Helsinki. Informed and written consent will be obtained from all the patients who are willing to participate. The CONSORT guidelines will be followed for reporting the study.
The study will be conducted as a randomized trial with two parallel arms. All the patients will be randomly assigned to either the test (PDDM +i-PRF) group or the control (no graft) group. Before the surgery, oral prophylaxis will be done and patients will be prescribed 0.2% chlorhexidine mouthwash. Surgical removal of the tooth will be done by an experienced Oral and Maxillofacial Surgeon under local anesthesia (2% Lignocaine with adrenaline). A baseline intra-oral periapical radiograph (IOPA) will be taken immediately after tooth extraction using a standardized technique and exposure.
To prepare the PDDM, all the soft tissues on the extracted tooth will be cleaned using a scaler. Caries/restorations will be removed using a high seed airotor with water. After airdrying the tooth will be ground into small particles using a grinder or bone mill. The particles will be demineralized using 0.6 N Hcl for 30 minutes and washed with buffered saline (pH 7.0) three to four times.
To prepare the novel i-PRF, 10 ml of venous blood will be collected from the cubital vein of the patient in a silica-coated vacutainer tube and centrifuged at 2000 g for 3 minutes. The i-PRF layer along with the buffy coat will be aspirated and mixed the prepared PDDM graft and allowed to clot.
The sockets in the test group will not receive any graft material. The site will be cleaned and irrigated followed by primary closure. The sockets in the test group will grafted with PDDM+ novel i-PRF graft followed by primary closure.
Relative Bone Density measurement:
On 3-month recall visit, a postoperative IOPA will be made using the same exposure parameters as done at baseline. The pre and post-IOPA images will be analysed in an image analysis software (Image J) to measure the change in the grayscale as described in previous reports. The change in the relative bone density (grayscale value) from baseline and 3 months will be calculated.
All patients will be recalled for follow-up on the 3rd day and the 14th day. The suture removal will be done on the 14th day.
Assessment of Pain: (3rd and 14th day)
A 10-point Visual Analog scale (VAS) will be used for measuring the pain scores on the 3rd day and 14th day. A score of 0 indicates “No pain” and 10 indicates “severe pain”.
Facial swelling: (3rd and 14th day)
The extent of facial swelling will be assessed using the method proposed by Schultze-Mosgau et al.[8] Briefly, the distance between the tragus to the corner of the lip and the tragus to the pogonion will be measured. The average of these measurements will be made pre-operatively and during the follow-up, visits. The change in the measurements from the baseline and on 3rd day, and 14th day will be expressed as percentages.
Mouth Opening: (3rd and 14th day)
The mouth opening will be measured as the maximum distance between the upper and lower incisors using a digital caliper. Trismus will be calculated as the difference in mouth opening at baseline and during follow-up visits and expressed as percentages.[8]
Graft loss/ rejection and postoperative infection:
All the patients will be followed for a period of 3 months. Any loss of the graft/ rejection or infection at the surgical site during the follow-up period will be noted.
Radiographic bone density and healing :
The radiographic bone density will be measured using any image analysis software as greyscale values.
The pre and post-IOPA images will be analyzed for bone healing using the scale proposed by Kelly et al.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 with impacted mandibular 3rd molar indicated for extraction.
- •vertical, horizontal, or mesioangular with mild to moderate difficulty (Pederson Classification).
- •Teeth with minimal caries / minimally restored
- •Patients with adequate mouth opening preoperatively.
- •Patients willing to come for follow-up visits.
排除标准
- •Impacted teeth that are grossly decayed / severe loss of tooth structure.
- •Complicated extraction – curved roots, fracture of the bone, or excessive intraoperative hemorrhage.
- •Patients with smoking/tobacco use.
- •Uncontrolled systemic diseases/bone/ bleeding disorders.
- •Patients with abscesses or periapical lesions.
- •History of allergy to any drugs/biomaterials.
- •Patients with a history of radiotherapy/chemotherapy.
- •Using drugs that may affect bone metabolism and healing (eg.
- •Bisphosphonates, steroids etc.,)
- •Pregnant and lactating women / contraceptive use.
结局指标
主要结局
To measure the relative bone density in the surgical site
时间窗: At baseline (immediately after tooth removal) and at 3 months
次要结局
- Evaluation of post-operative pain, swelling, mouth opening(Baseline (before extraction), 3rd day and 14th day)
- Graft loss/rejection and infection(Baseline to 3 months)
- Radiographic bone healing using(At baseline (immediately after tooth removal) and at 3 months)
研究者
Dr S K Jagdish
Chettinad Dental College and Research Institute