Marginal Bone Changes in Fixed All-on-Four Mandibular Prosthesis Using OT Bridge Attachment System Versus Conventionally Screw Retained Multiunit Abutments: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- marginal bone loss
研究概览
简要总结
Group I (control) Edentulous mandible receiving all on four fixed mandibular prosthesis using conventionally screw retained multiunit abutments.
Group II (intervention) Edentulous mandible receiving all on four fixed prostheses using OT bridge attachments system.
For both groups, the implant sites will be prepared aided by the surgical template. 4 implants with length 11-13 mm will be placed, two anterior implants will be aligned in an axial orientation and two posterior implants will be distally aligned according to the all-on-four concept in the inter foraminal area. Implants will be ideally placed at bone level.
For both groups:
After implant placement and surgical guide removal, healing abutments ( will be connected during healing periods (eight to twelve weeks).
Group I ( control) After eight to twelve weeks from implant placement, multiunit abutments with appropriate heights and angulations will be connected to the implants.
Group II ( intervention) After eight to twelve weeks from implant placement, narrow- and low-profile OT Equator abutment will be screwed onto the implants according to the manufacturer.
marginal bone changes and prosthetic complications are the outcomes Radiographic follow up will be performed for marginal bone changes Serial of standardized digital periapical radiographs using will be taken at the time fixed prosthesis insertion (baseline), 3,6,9,12 months.
Type and incidence of prosthetic complications for the prothesis for each group will be evaluated in 3, 6,9 and 12 months, these complications included: loosening or fracture of the prosthetic screw, prosthesis mobility and fracture of the prosthesis.
详细描述
Interventions will be conducted by principal investigator (N.O)
General operative procedures:
Eligible patients will be selected from outpatient clinic in prosthodontic department clinic. Patients Will be informed of the research work and informed consent will be obtained from each patient. Only motivated patients who show cooperation and has all the included criteria will be into the study.
Group I (Control):
Edentulous mandible receiving all on four fixed mandibular prosthesis using conventionally screw retained multiunit abutments.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with completely edentulous patients
- •Aged 40 years or older.
- •Sufficient inter -arch space not less than 13 mm.
- •Good oral hygiene
- •Minimum bone height 10 mm and minimum bone diameter should be 6 mm
排除标准
- •General contraindications for oral surgery
- •Heavy smokers (greater than 20 cigarettes a
- •Local acute or chronic infections
- •Substance abuse (drugs or alcohol)
- •Patients with neuromuscular or psychiatric disorders.
- •Treatment with intravenous bisphosphonates
- •Irradiation of the neck or head area in the past 5 years
- •Diabetic patients (HbA1c>7.5%)
研究组 & 干预措施
All-on-four fixed mandibular prosthesis using conventionally screw retained multiunit abutments.
Edentulous patients receiving All-on-four fixed mandibular prosthesis using conventionally screw retained multiunit abutments.
干预措施: patients reciveing all on 4 fixed mandibular prosthesis usimg conventionally screw retained multiunit abutments (Procedure)
All-on-four fixed mandibular prosthesis using OT bridge attachment system
Edentulous patients receiving All-on-four fixed mandibular prosthesis using OT bridge attachment system
干预措施: all on 4 fixed mandibular prosthesis using OTbridge attachment system (Procedure)
结局指标
主要结局
marginal bone loss
时间窗: 1 year follow up
Radiographic follow up will be performed for marginal bone changes. Serial of standardized digital periapical radiographs using; long cone paralleling technique, XCP periapical film holder and an individually constructed radiographic acrylic template will be taken at the time fixed prosthesis insertion (baseline), 3,6,9,12 months. The software of the Digora system will be used for evaluation of the marginal bone changes. Lines parallel to the long axis of the mesial and distal surface of each abutment will be made. The distance in mm from the crest of alveolar bone to the apex of the tooth will be measured and the marginal bone changes in the subsequent measurements will be calculated.
次要结局
- prosthetic complications(1 year follow up)
研究者
Nesma osama
assistant lecturer
Cairo University