CTRI/2022/03/041078尚未招募不适用
Clinical performance, patient and operator reported outcome measures of axially placed and tilted implants used for fixed rehabilitation of the edentulous maxilla: A pilot study.
International Team For Implantology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is the evaluation of prosthetic complications of CAD-CAM fabricated and denture-conversion prosthesis using modified USPHS scores at 3 months of function.
研究概览
简要总结
Implant supported restorations are now a predictable treatment modality for the rehabilitation of complete and partially edentulous jaws. The concept of tilted implants is well documented in the dental literature and high implant survival and success rates for rehabilitation of edentulous arches have been reported.Even though the concept of tilted implants is documented in the literature, the majority of the studies performed evaluated the success and survival rates of this technique without a proper control group.Therefore, in this study, besides the comparison between the two different reconstruction workflows , the patients will be randomized to receive axially or tilted implants. Overall, the expected outcome of this study might help clinicians in their decision making-process when rehabilitating cases of atrophic maxilla.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients should be of minimum 18 years to be included in the study.
- •Patient with edentulous maxilla.
- •Presence of natural teeth or dentures in the mandibular arch.
- •Presence of adequate primary stability during implant placement.
- •Adequate bone volume to place at least 4 implants with a standard diameter & at least 6 mm in length.
- •Presence of at least 6mm (height) of bone in the distal most prosthetic position (in the region of 2nd premolar or 1st molar).
- •Presence of at least 8 mm (height) and 6 mm (width) of bone in the anterior region to place an implant of a regular diameter with a minimum length of 8 mm.
- •Presence of healed maxillary edentulous ridge (at least 3 months post extraction).
排除标准
- •Self reported history of bruxism.
- •Uncontrolled diabetes (HbA1c>7.5 mg/dl).
- •History of irradiation in the head and neck region.
- •Inability to comply with annual implant maintenance follow up.
- •Ridge profile not allowing the placement of a fixed prostheses.
- •Presence of systemic disease that contraindicates implant placement.
- •Pregnant or lactating women.
结局指标
主要结局
The primary outcome of the study is the evaluation of prosthetic complications of CAD-CAM fabricated and denture-conversion prosthesis using modified USPHS scores at 3 months of function.
时间窗: 3 months
次要结局
- Survival rates:(To evaluate implant survival rates of tilted and axially placed implants at 1 year, 3 years and 5 years)
- Prosthetic Level:(Incidence of chipping of the final prostheses, fracture of abutment/ crown or frame work, fracture of veneering ceramic, occlusal roughness, loss of retention (loosening of crown or abutment screw) and the contour of restoration will be evaluated at 4 weeks after insertion of final prosthesis and at 1 year, 3 years and 5 years after function for final prosthesis using the Modified USPS scores.)
- Implant Level:(Fracture of screw and implant will be evaluated at 4 weeks after insertion of final prosthesis (BL1) and at 1 year, 3 years and 5 years.)
- PROMS:(-VAS scores based questionnaires about maintenance of oral hygiene, ability to speak, comfort and aesthetics will be evaluated at insertion of interim prosthesis ( Visit 3; prior to implant insertion,) at baseline and 3 months after use of provisional prostheses. Similarly VAS scores will be evaluated at the time of insertion of final prostheses (BL1) and at 1, 3 and 5 years after function.)
- Operator based preferences:(VAS scores based questionnaires for operator based preferences with respect to the ease of surgery and insertion of CAD-CAM fabricated provisional prostheses and denture conversion prostheses will be assessed after the insertion of provisional prostheses.)
- Clinical outcomes:(The following clinical outcomes will be evaluated at baseline after a functional period 3 months for provisional prostheses; and after insertion of final prosthesis (BL1) and after a functional period of 1, 3 and 5 years by using a dental probe)
- Radiographic Outcomes(Crestal bone loss)
研究者
研究点 (1)
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