The Impact of Provisionalization Using Fiber-Reinforced Composite on the Quality of Life and Bone Height Changes in Maxillary Implant Supported Arches Restored by Final PEKKTON Frameworks: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 主要终点
- Oral health related to quality of life
研究概览
简要总结
The aim of this study is assessing the effect of provisionalization with a glass fiber composite framework on patients' quality of life and bone height changes before the insertion of a definitive PEKKTON framework of screw-retained maxillary implant-supported prosthesis at a one-year follow-up period.
详细描述
- Patient grouping:
Group I, (control): patients obtained an Implant-supported, full arch maxillary definitive prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization.
Group II, (intervention): Patients obtained an Implant-supported full arch maxillary provisional prosthesis protocol utilizing 6 implants for constructing a resin glass fiber composite framework followed by a definitive PEKKTON framework. 2. Preparation of a scan appliance:
- The patient's denture will be used as a scan appliance by the addition of radiopaque material to act as radiopaque markers over the polished surfaces of the prosthesis in a staggered pattern at different levels to the occlusal plane on the buccal, labial, and palatal flanges of the denture.
- Double scan protocol will be used in our study in which a cone beam conventional tomography (CBCT) images will be produced for each case. The first scan will be taken for the maxilla while the patient is wearing the maxillary denture with the radiopaque markers and biting over cotton rolls, the other scan is for the modified maxillary denture.
- Computer software (BlueSky Bio) was used to overlap the two scans on each other where the final file contained reformatted images in 3D bone model, and 3D radiographic modified denture guide model to construct the surgical guide.
- Virtual planning, surgical guide fabrication, and Implant placement
- The implant planning will be done using the BlueSky Bio software. The scan of the maxillary denture will be superimposed over that of the maxillary arch scan, using points over the radiopaque marker as alignment points, for proper orientation of the scan appliance.
- 6 Implant planning ( 3.7x12 for anterior segment and 4x10 for the posterior segment) will be placed in areas with high bone quality and quantity of bone and will be distributed according to AP spread.
- A surgical guide will be planned and then the 3D virtual guide will be exported as STL file to the 3D printing machine. The surgical guide will be fixed in place using three fixation screws; with an adequate distance from the planned implant drilling sites, two screws placed in the buccal shelf area on both sides and one screw in the midline to achieve a tripoding position.
- The 3D surgical guide will be provided with metal sleeves corresponding to the virtually planned drilling sites with the precise depth, angulation, mesiodistal and buccolingual positioning of each implant as planned during the computer simulation for accurate placement of the implants' osteotomies. The osteotomies will be drilled, and implants will be inserted.
- The Multi-unit abutments will be placed over the dental implants, the denture will be relieved and picked up with soft liner.
- All patients will be instructed about oral hygiene measures, a soft diet for 4 weeks after surgery, and antimicrobial prophylaxes (amoxicillin 500mg twice daily for 5 days starting 1 hour before surgery). Postsurgical analgesic treatment will be performed with ibuprofen 600mg twice daily.
- Prosthetic procedures:
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 (Outcomes Assessor)
盲法说明
The study is based on different technical procedures of framework fabrication. Since these differences are visible, the operator and the patients involved in the study cannot be blinded. But the outcome assessor and the statistician will be blinded.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Completely edentulous patients with Angle's Class I maxillomandibular relationship
- •Age ranges from 40 to 65 years old.
- •Adequate zone of keratinized attached mucosa (≥ 8mm) over the maxillary crest.
- •Absence of any medical disorder that could complicate the surgical phase or affect osseointegration.
- •The patient must have enough bone height for implants, a minimum length of bone
- •12 mm, and a minimum diameter of bone 6 mm.
- •Patients with good oral hygiene.
- •Adequate inter arch space for screw-retained prosthesis.
- •Absence of any intra-oral pathological condition.
排除标准
- •• Patients with recent extraction (less than three months).
- •Patients with an inflamed ridge or candida infection
- •Patients with the flabby ridge.
- •Para functional habits.
- •Cancer patients receiving chemotherapy and/or radiotherapy.
- •Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c ≥ 7)
- •Potentially uncooperative patients who are not willing to go through the proposed interventions.
- •Moderate-to-heavy daily smokers (more than ten per day)
结局指标
主要结局
Oral health related to quality of life
时间窗: 1 year
A translated form from a validated questionnaire will be used to address the Egyptian population; all patients have to answer the same questionnaire. Each answer will be given a score from 0 to 4 where the lesser the score the better the quality of life, data will be collected, and privacy will be ensured.
次要结局
- Bone height changes assessments(1 year)
研究者
Haydi Hesham Mohamed Issa
principle investigator ( assistant lecturer of prosthodontics)
Cairo University