PEEK Versus Metallic Framework for Extra Coronal Attachment Mandibular Bilateral Distally Extension Removable Partial Denture- Evaluation of Abutments Bone Height Changes and Patient Satisfaction. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- evaluation of bone height changes
研究概览
简要总结
Purpose: The present study was aimed to evaluate the bone height changes around abutments with two different framework materials for extracoronal attachment mandibular bilateral distally extension removable partial denture (RPD) and compare patient satisfaction associated with its use.
Materials and methods:
Ten partially edentulous patients (long span kennedy class I) were selected, for all patients splinting of remaining abutment were done by porcelain fused to metal bridges, after cementation the RPD frameworks were digitally designed by CAD software and printed into 3-D resin pattern after intra-oral try in of these patterns, the patients were divided into two equalized groups, the patients in first group received extracoronal attachment (RPD)with from milled PEEK (Juvora) framework. While patients in second group received extracoronal attachment (RPD) with conventional metal framework by lost wax technique. Digital radiography was used for bone height assessment of distal abutment at time of prosthesis insertion, 6 and 12 months later. Patient satisfaction was measured using VAS scale.
详细描述
I-Patient selection For this study, ten patients (50-60) with mean age 55 years will be selected from out clinic patients Prosthodontic Department, Faculty of Dentistry, Kafr El_Sheikh University. The patients will have the following inclusion criteria:- Completely edentulous maxillary arch against partially edentulous mandible with only remaining mandibular anterior teeth. The selected patients will be free from any systemic diseases, the patients have Angle class I maxillomandibular skeletal relation, the distal extension ridge will be well formed and covered by healthy, firm mucosa, Good abutments with healthy periodontal ligament and suitable crown/root ratio (CRR) as verified by periapical radiograph.
The exclusion criteria to the patients were:
Patients with any systemic disease that could affect the rate of bone resorption which verified by obtaining a medical history, Patients with Para-functional habits (Bruxism and clenching), Patients with any septic foci or impacted teeth as verified by panoramic radiograph, Patients with tilted or rotated abutments. Patients with soft tissue undercuts involved in the design.
For every patient the following procedures were done:
- Diagnostic Digital panoramic X-ray will be done, then Diagnostic Long Cone standard Digital peri-apical radiographs for canines will be taken to determine crown /root ratio.
- Scaling and/or root planning for remaining mandibular anterior teeth will be carried out, follow up of good oral hygiene measures before start of treatment plan for one month
- Correction of irregular occlusal plane will be done either by enameloplasty for overerupted teeth or restoration by adding composite for infraerupted one if needed.
- All selected patients in this study will be informed about all procedures that will be done and the need for regular and frequent recalls. All patients will sign the consent form of ethical committee in Faculty of dentistry, Kafr El_Sheikh university.
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 (Investigator)
入排标准
- 年龄范围
- 55 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The average age of selected patients was from 55 -60 years .
- •Completely edentulous maxillary arch opposed by partially edentulous mandible with only remaining mandibular anterior teeth.
- •All selected patients were free from any systemic diseases,
- •All patients had Angle class I maxillomandibular skeletal relation,
- •The distal extension ridge was well formed and covered by healthful, firm mucosa,
- •Suitable abutments with healthy periodontal ligament and appropriate crown/root ratio (CRR) as verified by periapical radiograph.
排除标准
- •to the patients were:
- •patients with any systemic disease that could affect the rate of bone resorption which confirmed by obtaining a medical history,
- •Patients with Para-functional habits (Bruxism and clenching),
- •Patients with any septic foci or impacted teeth as proved by panoramic radiograph,
- •Patients with tilted or rotated abutments. Patients with soft tissue undercuts had involved in the design.
研究组 & 干预措施
RPD frameworks fabricated from PEEK material
14 patients received extracoronal precision attachment RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology)
干预措施: RPD frameworks fabricated from PEEK material (Other)
RPD frameworks fabricated from Co-Cr
14 patients received extracoronal precision attachment RPD frameworks fabricated from Co-Cr material using casting machine
干预措施: RPD frameworks fabricated from PEEK material (Other)
结局指标
主要结局
evaluation of bone height changes
时间窗: 12 months
An image plate was attached on a radiographic stent specially constructed for each patient to made a standardized periapical radiograph for the abutments by using the Dentsply/rinn XCP tools (long, round BID cone paralleling technique) according to: Image analysis: The linear measurement system contributed by the special software of the Vista-scan machine was used for measuring the mesial and distal marginal bone height around the canine abutments bilaterally in both groups.
次要结局
- Patient satisfaction (VAS)(12 months)
研究者
Nourhan Ahmed Ragheb
Lecturer , Prosthodontist, Department of Prosthodontics, Faculty of Oral & Dental Medicine,Kafr El-shiekh University, Kafr El-shiekh ,Egypt.
Kafrelsheikh University