Clinical Performance, Patient and Operator Reported Outcome Measures of Axially Placed and Tilted Implants Used for Fixed Rehabilitation of the Edentulous Maxilla.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complications of CAD-CAM prosthesis
研究概览
简要总结
The principal aim of the study is to evaluate the prosthetic complications with CAD-CAM fabricated provisional prostheses and denture conversion prostheses after 3 months of function. Supported restorations are now a predictable treatment modality for the rehabilitation of complete and partially edentulous jaws.Immediate loading of the placed implants is performed for the rehabilitation of the edentulous arch to improve patients' function. This can be usually done by converting the existing denture base of the patient or by making a CAD- CAM milled provisional prosthesis integrating digital workflow. A laboratory fabricated denture base can be converted into a screw-retained provisional prosthesis post implant placement. This is known as conversion prosthesis. However, drawbacks of these prostheses include increased chairside time for the clinician leading to inconvenience for the patient and a potential for an error in prosthesis fabrication. With the introduction of CAD-CAM technology, it is now possible to fabricate a provisional restoration using digital workflows. This workflow would help the clinicians save a considerable amount of chairside time and obtain potentially stronger restorations better polished and without contamination of surgical field. Studies assessing the soft tissue response and patient-reported outcome measures between denture conversion and CAD- CAM fabricated provisionals are currently lacking in the literature.
详细描述
- Study Intervention and Indication CAD-CAM fabricated provisional prostheses facilitate prosthesis delivery in immediate functional loading protocols. The prostheses are manufactured in the laboratory by milling high-density polymers based on a highly cross-linked polymethylmethacrylate (PMMA). The prostheses are known to have higher biocompatibility, superior esthetics and soft tissue response as compared to denture conversion prostheses.
The indication is edentulism. CAD-CAM fabricated prostheses are implant supported prosthesis and are indicated for rehabilitation of edentulous arch. 2. Justification of Study Intervention With the introduction of CAD-CAM technology, it is now possible to fabricate a provisional restoration using digital workflows. This workflow would help the clinicians to save a considerable amount of chairside time and to obtain potentially stronger restorations better polished and without contamination of surgical field. 3. Risk / Benefits The participants will be exposed to only minor risks (loosening of prosthesis), as all procedures used in this study for rehabilitation of the patients have been used in dental clinics. The safety and risk profiles are well known. Patients will be locally anesthetized during the procedure of implant placement. Well-experienced dentists who are very familiar with the procedures and materials used will perform the surgeries. On the other hand, a significant gain of knowledge will be expected by the use of CAD-CAM fabricated and denture conversion provisional prostheses. This will open new insights in respect to rehabilitation of the patients undergoing full arch reconstructions. Consequently, this will open new therapeutical opportunities in order to provide the best and most adequate treatment strategy for future patients.
It is ethically justifiable that the patients included in this study will receive the CAD-CAM fabricated provisional prosthesis as well as the denture conversion prosthesis as this represents todays standard and most often performed procedure.
Anticipated adverse effects and residual risks encompass loosening of the prosthesis. 4. General Study Design and Justification of the design This study will be designed as monocenter prospective randomized, controlled, clinical trial with two parallel study groups and a follow-up duration of 5 years after insertion of the final prostheses.
Treatment interventions and follow-up:
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
As the placement of implants and the type of implant is clearly distinguishable and require different handling, blinding of the prosthodontist is not feasible.
Patients are blinded to the type of implant received and to the type of procedure followed for the fabrication of the provisional prosthesis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 regular platform of 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 (canine or lateral incisor) to place an implant of a regular diameter and a minimum length of 8 mm.
- •Presence of healed maxillary edentulous ridge (at least 3 months post extraction)
- •Written informed consent
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 any uncontrolled systemic disease that contraindicates implant placement.
- •Pregnant or lactating women
研究组 & 干预措施
CAD-CAM fabricated provisional prothesis
Insertion of CAD-CAM fabricated provisional prosthesis (CAD-CAM) on axially placed or titled implants for rehabilitation of atrophic maxilla
干预措施: CAD-CAM fabricated provisional prosthesis (Device)
Insertion of denture conversion (DC)
Insertion of denture conversion (DC) provisional prosthesis on axially placed or titled implants for rehabilitation of atrophic maxilla
干预措施: DC (denture conversion) provisional prosthesis (Device)
结局指标
主要结局
Complications of CAD-CAM prosthesis
时间窗: 3 months of function
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. USPHS (United States Public Health Service) criteria A, B, C D are used where when rated A an excellent restoration is achieved and D is rated as failure.
次要结局
- Clinical outcome(4 weeks and 3 months - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis)
- Evaluation about ease of surgery(8 weeks after interim prosthesis insertion)
- Survival rates(1 year, 3 years and 5 years after insertion of final prosthesis)
- VAS provisional prosthesis(4 weeks - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis)
- Radiographic Outcome(4 weeks and 3 months - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis)
- OHIP-14 provisional prosthesis(4 weeks - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis)
- Technical outcomes and complications: Prosthetic level(4 weeks - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis)
- VAS final prosthesis(4 weeks - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis)
- Technical outcomes and complications: Implant level(4 weeks - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis)
- OHIP-14 final prosthesis(4 weeks - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis)
- Evaluation of ease of treatment(8 weeks after interim prosthesis insertion)