Alveolar Socket Preservation Following Autogenous Bone Grafting Using Auto-Chip Maker In 3rd Molar Extraction Site: An Experimental Study
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Autogenous Bone Grafts is the gold standard in bone regeneration.
研究概览
简要总结
Autogenous bone graft being a bone graft harvested from the patient’s own body is considered the ‘Gold standard’ amongst other options, due to its superior osteoconductive, osteo-inductive and osteogenic properties.An Auto-Chip Maker serve as an essential tool for harvesting autogenous bone from the mandibular molars or incisors, for achieving guided bone augmentation in the defected site. The use of this device makes it possible to obtain uniform bone chips in minimally traumatic manner for use in bone grafting procedures. Its automation features significantly increase the process and accuracy of use in grafting, shortening the surgery time and improving the clinical outcome for patients.
Patients will be informed about the full procedure, potential benefits, and possible complications through the participant Information Sheet (Appendix I), while written informed consent of all the patients will be taken in their vernacular language (Appendix II). The data of all subjects will be recorded on a customized case history Performa (Appendix III).
Before the surgery, a radiograph will be performed to assess the quality and amount of remaining bone, a clinical evaluation of occlusion will be conducted to identify the available inter-arch space, and laboratory tests will be carried out to check for any underlying systemic conditions.
Surgical planning will be done based on the pre-operative radiograph. Gow Gates Mandibular nerve block will be administered for both pain control and local haemostasis in all patients using local anaesthesia of 2% lignocaine hydrochloride with 1:80000 adrenaline solution.
The tooth will be accessed using a ward’s incision starting at the cervical line of the second molar and extending posteriorly and laterally along the front edge of the ramus. After the tooth is exposed, Bone removal will be done buccal and distal to the impacted tooth by guttering, preserving the lingual aspect, tooth will be then extracted by application of elevator. After wound toileting, a stab incision will be made in the mucobuccal ford at the donor site to reveal the bone underneath.
Next, attach the mount stopper to the auto-chip maker and connect it to the dental implant motor. Position the drill at the donor site by applying gentle pressure while using ample saline irrigation13. The suggested drilling speed ranges from 50 to 300 rpm, with a maximum torque exceeding 50 N cm, while ensuring that the stopper does not exceed 4 mm.
Once the harvested bone is placed in the cavity, remove the bone chips from the Auto-chip Maker and transfer them to the stainless-steel bowl after taking off the stopper. Bone harvested from auto-chip maker will be compacted at the 3rd molar extraction site and sutured.
The patient will be instructed to maintain strict oral hygiene practices and to continue the necessary medications following the surgery. Povidone-iodine mouthwash will be used three times a day for one week, beginning 24 hours after the operation.
Clinical follow-up will occur at 24 hours, 72 hours, and 1 week, at which point sutures will be removed, as well as at 1 month, 3 months, and 6 months after the operation. Radiographs will be taken immediately after the procedure, at 3 months, and at 6 months post-operation to evaluate and assess the extent of bone gain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy adult individuals between 18-35 years.
- •Patient should have adequate bone availability in donor sites.
- •Patient who is willing to give informed consent.
排除标准
- •Patient associated with local site infection or inflammation in donor site.
- •Patient who are on medication for any systemic conditions like pregnancy.
- •Patient with history of past surgery or trauma reducing the availability of bone at donor site.
- •Patient with a history of smoking and tobacco consumption.
结局指标
主要结局
Autogenous Bone Grafts is the gold standard in bone regeneration.
时间窗: 24hrs, 72hrs, 1 week, 1 month, 3 month and 6 month.
次要结局
- Autogenous Bone Grafts is the gold standard in bone regeneration.(Immediate, 3 months, 6 months)
