Radiographic and Histological Assessment of Guided Bone Regeneration Using Deproteinized Bovine Bone Compared to Spontaneous Bone Regeneration of Maxillary Defects , Resulted From Enucleation of Intra-bony Cystic Lesions : Randomized Control Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The amount of change in the Bone density
研究概览
简要总结
Two groups of patients with maxillary defects resulted from enucleation of intra-bony cystic lesions the 1st group will be subjected to guided bone regeneration while the second group will be subjected to spontaneous bone regeneration.
详细描述
-
Two groups of patients with maxillary cystic lesions indicated for enucleation. One will be subjected to guided bone regeneration while the other will be subjected to spontaneous bone regeneration.
-
General pre-operative procedures:
-
All patients will undergo appropriate preparation involving periodontal therapy , proper oral hygiene measures in addition to endodontic treatment for the non-vital teeth related to the lesion.
intraoperative procedure: (both groups)
- Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
- Local anesthesia will be administered (Articaine hydrochloride 4% with Epinephrine 1:100,000) injectable solution.
- Flap design: a sulcular incision will be done , extending two teeth beyond the area of interest followed by two oblique incisions on either side of the flap. A full thickness mucoperiosteal flap will be raised to expose the area occupied by the lesion.
- After flap reflection, the exposed bone related to the lesion will need to be removed to provide adequate accessibility before enucleation of the lesion.
- The specimens will be fixed in 10% formalin for pathological examination.
Intra-operative procedures - continued in first Group (GBR group) The intra-bony defect will be filled with Deproteinized Bovine Bone. In Both groups: Titanium mesh will be tailored with 3mm overlap at the edges to cover the bone window completely and fixed to the bone using mono-cortical titanium screws.
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
- Single (Participant)
盲法说明
This trial is considered a randomized single blind clinical trial due to the following:
- The participants will be blinded to the technique that will be used during the surgical procedure.
- The operator will not be blinded for both techniques during the surgical procedure as the two techniques are different.
- The outcome assessor cannot be blinded.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a well-defined pathological cystic lesion involving the maxilla, confirmed clinically and radiographically that require surgical enucleation resulting in an intra-bony defect.
- •Mesiodistal dimension of the defect ranging from 1 cm to 4.0 cm.
- •Patients aged 20 to 50 years, of either sex.
- •Patients medically fit for surgical intervention under local or general anesthesia (ASA I or II)
- •Absence of systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis)
- •Patients willing to participate in the study and able to provide informed written consent.
- •Availability of adequate postoperative follow-up (minimum of 6 months).
排除标准
- •Pregnant or lactating women.
- •Radiographically, Presence of multi-locular or aggressive lesions suggestive of odontogenic tumors (e.g., ameloblastoma)
- •Patients with compromised immune status (e.g., HIV, long-term corticosteroid therapy)
- •History of allergic reaction to any of the surgical materials used (e.g., titanium, bovine bone graft).
- •Patients participating in another clinical trial or receiving investigational therapy during the study period.
- •Presence of acute infection at the surgical site.
- •cysts with a known high recurrence rate such as Odontogenic keratocysts (OKC).
研究组 & 干预措施
spontaneous bone regeneration
after cyst enucleation, the intra-bony defect will be covered by Titanium mesh that is fixed by mono-cortical titanium screws.
干预措施: spontaneous bone regeneration (Procedure)
guided bone regeneration
cyst enucleation will be followed by filling the intra-bony defect with Deproteinized Bovine Bone.
-Titanium mesh will cover the bone window completely and will be fixed to the bone using mono-cortical titanium screws.
干预措施: guided bone regeneration (Procedure)
结局指标
主要结局
The amount of change in the Bone density
时间窗: 6 months postoperatively
Measuring the amount of change in the bone density using cone beam computed tomography in hounsfield unit
次要结局
- Percentage of bone area(6 months postoperatively)
研究者
Alaa Mohamed Abdelzaher
Principal investigator
Cairo University