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临床试验/NCT04814160
NCT04814160已完成不适用

Ridge Splitting and Simultaneous Implant Placement With Autogenous Bone and Bioactive Glass for the Treatment of Maxillary Horizontal Bone Defects: A Randomised Clinical Trial

Kafrelsheikh University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
measuring the survival rates

研究概览

简要总结

Objective: To compare the use of autogenous bone graft versus autogenous bone graft mixed with bioactive glass bone graft in the treatment of maxillary anterior horizontal bone defects by ridge splitting technique combined with simultaneous implant placement.

Materials and methods: Twenty-two patients were divided randomly into two groups; control group and study group. In control group, bone expansion was performed and autogenous bone was used to augment the intercortical bone defect. In study group, bone expansion was performed and autogenous bone mixed with bioactive glass was used to augment the intercortical bone defect. In both groups, the implants were inserted simultaneously with ridge splitting. 6 months after implant placement, the mean bone width and alveolar bone loss values were evaluated. Statistical analysis using paired Student's t- test to compare results within the same group of patients, whereas, independent samples t-test was used to compare variables between the two groups

详细描述

Participants' selection:

22 patients, aged from 18 to 50 years, were selected in this prospective, randomized and blinded clinical trial from the Outpatient Clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Kafrelsheikh University. Those subjects had inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges. The research ethical committee of Faculty of Dentistry, Kafrelsheikh University approved the study (KD/06/21). Research procedures were explained to all patients, and they agreed to participate in the study and signed the appropriate informed consent form. The inclusion criteria implemented for patient selection were good general health at the time of surgery; at least 3months postextraction healing period; and horizontally compromised maxillary anterior alveolar ridges (at least 3mm bone width and 13mm bone height). The criteria of patients exclusion were vertical bone defect; thick labial cortex with less cancellous bone inside; obvious undercut on the labial/buccal side; uncontrolled periodontal conditions; history of radiotherapy in the head and neck region; uncontrolled diabetes mellitus or other systematic disorders; smokers; pregnancy; non-compliant patients; and allergic reaction to the used medications.

Pre-surgical therapy and grouping Pre-surgical therapy consisted of a thorough full-mouth scaling and root planning. Patients were randomly assigned immediately before surgery into two groups (11 patients each) by computer-assessed randomization software (Random Allocation Software, Version 1.0). Control group received ridge splitting with simultaneous implant placement in combination with autogenous bone graft alone, while study group used (1:1) mixture of autogenous and bioactive glass bone grafts. Bone volume was assessed two weeks before operation using CBCT (Scanora 3D, Soredex Oy, Tuusula, Finland).

Surgical procedure:

Operations were performed under local anesthesia. Mid-crestal incision followed by full thickness flap reflection to expose surgical site. Mid crestal cut using piezo-surgery unit (Piezotome® Cube, ACTEON®, Acteon Group Ltd, Norwich, England). Then, the cut was extended deep to the length of implant. Then, ridge was expanded progressively using bone wedges (Microdent Implant System, Spain). Implant location was marked, with a buccal bony wall as uniformly thick (>1 mm) as possible to avoid bone fracture. The implant site was prepared and 3.75*13 mm dental implant fixture (Humana Dental Implants & Accessories GmbH, Germany) was placed stably in between the two bony plates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • good general health at the time of surgery
  • at least 3months postextraction healing period
  • horizontally compromised maxillary anterior alveolar ridges (at least 3mm bone width and 13mm bone vertical height).

排除标准

  • vertical bone defect
  • thick labial cortex with less cancellous bone inside
  • obvious undercut on the labial/buccal side
  • uncontrolled periodontal conditions
  • history of radiotherapy in the head and neck region
  • uncontrolled diabetes mellitus or other systematic disorders
  • pregnancy
  • non-compliant patients
  • allergic reaction to the used medications.

结局指标

主要结局

measuring the survival rates

时间窗: 6 months

survival rates of implants

Clinical measurements of pain intensity

时间窗: 6 months

pain intensity verbal rating scale either mild, moderate or sever

Clinical incidence of implants mobility

时间窗: 6 months

Implants mobility

次要结局

  • radiographic results of bone width and height(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walid Elamrousy

lecturer of oral medicine and periodontology

Kafrelsheikh University

研究点 (2)

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