Implant Survival in Two-piece Versus Single-piece Patient-specific Titanium Subperiosteal Implants in Atrophied Edentulous Mandibles: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Implant survival
研究概览
简要总结
The objective of this trial is to find out if there is a difference between single-piece and two-piece titanium patient-specific mandibular subperiosteal implants in terms of implant survival, patient satisfaction, and soft tissue dehiscence. This is to enhance both surgical and prosthetic outcomes for the sake of improved implant longevity, soft tissue health and patient well-being.
详细描述
After obtaining a thorough medical and dental history and performing necessary laboratory investigations, the following steps will be undertaken:
Preoperative prosthetic preparation:
- For eligible patients who are already wearing upper and lower complete dentures: The dentures will be checked for adaptation, fit, stability and occlusion.
- For eligible patients who are not wearing upper and lower complete dentures:
Preliminary alginate impressions will be made using a perforated stock tray for both the maxillary and mandibular arches. Impressions are then poured into dental stone to obtain the diagnostic models. Occlusion blocks will be constructed over the diagnostic models, followed by bite registration, try-in and delivery of upper and lower complete dentures.
Afterwards, approved complete dentures will be duplicated using laboratory condensation silicone to construct a radiographic stent. The radiographic stent is prepared by using a ratio of 3:1 acrylic resin to barium sulphate mixture, and then the patient is sent for a Cone Beam Computed Tomography (CBCT) scan.
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
盲法说明
After assignment to interventions, blinding of trial participants, care providers and outcome assessors is not applicable. Data analysts will be blinded.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous male or female patients with atrophied mandibles between the ages of 50 to
- •Atrophic mandibular ridges in terms of width and height, impeding the possibility of placing a root form dental implant of at least 3mm in diameter and 8 mm in length.
- •Completely edentulous patients (with the above mentioned criteria) who can't stand a soft-tissue supported mandibular denture.
排除标准
- •Patients having a medical condition that absolutely contraindicates implant placement.
- •Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
- •Potentially uncooperative patients who are not willing to go through the proposed interventions.
- •Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
- •Patients who are satisfied with their soft-tissue supported mandibular denture.
研究组 & 干预措施
Two-piece subperiosteal implant
The two-piece subperiosteal implant will be designed with an internal connection that will receive its prosthetic counterpart later in the second stage surgery, which will retain the final prosthesis in place. Two-piece constructions allow for undisturbed submerged healing, without being exposed to the oral environment, achieved by attaining primary closure over the inserted implant body.
干预措施: Subperiosteal implant (Device)
Single-piece subperiosteal implant
The single-piece subperiosteal implant will be designed in the from of a framework with protruding posts that will appear penetrating through the mucosa, and will later carry the overlying superstructure (prosthesis). Single-piece subperiosteal implants do not require a second stage surgery.
干预措施: Subperiosteal implant (Device)
结局指标
主要结局
Implant survival
时间窗: 12 months (post-surgery)
Implant survival will be assessed by evaluation of the following criteria: a) Persistent pain, and/or b) mobility and/or c) persistent exudate In case of presence of one or more of the previously mentioned criteria, implants will be regarded non-survived. Presence of persistent pain either spontaneous or during function Presence of clinically detected mobility Evidence of infection in the form of pus formation or persistent inflammatory fluid exudate
次要结局
- Implant survival(3 months (post-surgery))
- Patient satisfaction(At 1,3,6 and 12 months (after loading of final prosthesis))
- Soft tissue dehiscence(At 1,3,6 and 12 months (post-surgery))
研究者
Mariam Ahmed Roshdy
Assistant lecturer, Department of Prosthodontics, Faculty of Oral and Dental Medicine, Cairo University
Cairo University