Evaluation of the Effect of Platelet Rich Fibrin Membrane on the Neurosensory Dysfunction Following Inferior Alveolar Nerve Lateralization for Implant Placement"A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Subjective assessment of the change in the neurosensory function of inferior alveolar nerve
研究概览
简要总结
In many cases the bone of the edentulous posterior mandibular regions is atrophied such that sufficiently long fixtures cannot be placed without encroaching on the inferior alveolar nerve so rehabilitation of these regions with severe ridge atrophy represents anatomical, surgical, and biological difficulties, and provides a challenge to the dental surgeon.
Several surgical techniques have been employed in an attempt to allow implant placement in these regions. one of these techniques is inferior alveolar nerve transposition or lateralization.
The lateralization of the inferior alveolar nerve has the advantages of that it allow placement of longer implants which gives better stability,but this technique has the disadvantage of high risk of temporary or permanent inferior alveolar nerve dysfunction.
In most of the cases of inferior alveolar nerve lateralization it is directly repositioned on the implant surface or a bone graft is placed in between them.
In a previous study on dogs found that presence of a resorbable membrane between the inferior alveolar nerve and the implant surface lead to the formation of a soft tissue zone between them while in the group where no membrane was used there was intimate contact between them.This intimate contact may lead to the dysfunction symptoms,also the intimate contact between the implant threads and the nerve act as a source of chronic irritation.
Platelet rich fibrin membrane is a platelet concentrate which allow slow and sustained release of high quantities of growth factors over long period of time thus improves healing of hard and soft tissue and optimizing wound healing.
in this study we will assess the effect of platelet rich fibrin membrane on the improvement of the neurosensory disturbances which occur after inferior alveolar nerve lateralization which considered as the main disadvantage of this technique.
详细描述
Background and rational:
In many cases the bone of the edentulous posterior mandibular regions is atrophied such that sufficiently long fixtures cannot be placed without encroaching on the inferior alveolar nerve so rehabilitation of these regions with severe ridge atrophy represents anatomical, surgical, and biological difficulties, and provides a challenge to the dental team.
Several surgical techniques have been employed in an attempt to allow implant placement in these regions. These include bone grafting, distraction osteogenesis, inferior alveolar nerve transposition or lateralization (IANL), and placement of fixtures in a lingual position to the neurovascular bundle.
The lateralization of the inferior alveolar nerve(IAN) has the advantages of that it allow placement of longer implants, gives better initial stability due to bicortical anchorage, and reduces the treatment time. Also it increases the resistance to the occlusal forces and improves the proportion between the implant and prosthesis.
This technique has the disadvantage of it is a complex procedure, with a high risk of complications which include temporary or permanent inferior alveolar nerve dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double blinded ,participant and outcomes assessor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients requiring dental implants placement in the posterior region and has insufficient bone height above the inferior alveolar canal to accommodate for implant placement.
- •Patients should be free from any systemic conditions that may affect normal healing.
排除标准
- •Patients with systematic disease that may complicate healing.
- •Uncontrolled diabetic patient.
- •Patients with advanced osteoporosis.
- •Patients under bisphosphonates treatment.
- •Heavy smoker patients.
结局指标
主要结局
Subjective assessment of the change in the neurosensory function of inferior alveolar nerve
时间窗: pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative
a 10 cm, 5 degree visual analogue scale with divisions at 2.5 cm intervals, the divisions on the VAS was: 1. Complete absence of sensations. 2. Almost no sensation. 3. Reduced sensation. 4. Almost normal sensation. 5. Fully normal sensation. Patients were asked to mark "x" on the line at each testing session that represent their opinion about sensation of the lower lip.
次要结局
- clinical assessment of the change in the neurosensory function of inferior alveolar nerve:(pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative.)
- clinical assessment of the change in the neurosensory function of inferior alveolar nerve :(pre-operative assessment and (base line) 1 week,2 weeks, 1 month, three months,six months postoperative.)
- clinical assessment of the change in the neurosensory function of inferior alveolar nerve(pre-operative assessment (base line) and 1 week,2 weeks, 1 month, three months,six months postoperative.)
研究者
Eman Sayed Ahmed Shalaby
Principal Investigator
Cairo University