Evaluation of Hyaluronic Acid in Addition to Xenograft Material in Treatment Peri-implant Bony Defects in Immediate Implant Placement Within Maxillary Esthetic Zone
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- radiographic marginal bone change
研究概览
简要总结
Study design:
The present study will be carried out on twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant divided into two groups. A written informed consent will be obtained from all patients before their participation in this study.
Evaluation of study:
All patients will be seen at regular time interval for evaluation at the visit of surgical intervention , follow up of clinical parameter will be recorded monthly then three , six months postoperative and six month after loading(with twelve month follow up study).
- Clinical evaluation:
Implant stability evaluation Soft tissue evaluation 2. Radiographic evaluation:
- Marginal bone loss(MBL).
详细描述
Study design:
The present study will be carried out on two groups of patients.
A-Patients Sample:
Twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant. A written informed consent will be obtained from all patients before their participation in this study.
i. Group (1): Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral graft material( cerabone®,Botiss biomaterial) followed by healing abutment.
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)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients who are medically free from any systemic diseases.
- •Patients with good oral hygiene and regular maintenance.
- •Age of patients will be >20 years.
- •Presence of at least single non restorable maxillary anterior and/or premolar tooth due to caries, root resorption, endodontic failure, root fracture or tooth with open apex.
- •No acute infection is present within both periodontal and/or peri-apical area within the tooth of concern and/or adjacent teeth.
- •Patients with extraction socket type I.
- •Free from history of clenching, tapping and bruxism.
- •Patients prepared to co-operate and comply with the follow-up and maintenance program.
排除标准
- •• Patients taking medications known to influence bone metabolism ( such as heparin, warfarin, corticosteroid).
- •Smoking and alcoholic patients.
- •History of radiation in the head and neck region.
- •Insufficient interocclusal distance for implant placement and restoration.
- •Patient with lack of stable posterior occlusion.
- •Pregnant, lactating and post-menopausal female patients. Complete medical history, dental history will be taken to all of patients in the study.
研究组 & 干预措施
immediate dental implant with cerabone®
Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral graft material( cerabone®,Botiss biomaterial) followed by healing abutment.
干预措施: cerabone (Procedure)
immediate dental implant with cerabone plus®
Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial) followed by healing abutment.
干预措施: cerabone®plus (Procedure)
结局指标
主要结局
radiographic marginal bone change
时间窗: preoperative , at time implant placement, six and twelve months after implant placement
Radiographic cone beam tomography (CBCT) assessment will be held preoperative ,at time implant placement, six and twelve months after implant placement
Implant stability evaluation
时间窗: at time of placement, three , six months after surgery to assess secondary implant stability
Using Osstell implant stability will be assessed in both groups soon after implant placement to assess primary implant stability then three , six months after surgery to assess secondary implant stability
次要结局
- Soft tissue evaluation(monthly then three , six months postoperative and six month after loading)
研究者
Rabia Mohamad Dakhil
M.Sc.- Master Degree of Oral Medicine & Clinical Periodontology
Mansoura University