Nylon Clip Wear and Patient Perception in Implant Retained Mandibular Overdenture Using PEEK Versus Metal Bar :One Year Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- attachment clip wear
研究概览
简要总结
This study is aimed to compare the wear of nylon caps and patient satisfaction in two-implant overdentures with metal bar and Peek bar overlays in the premolar area:
This prospective clinical trial will involve 14 edentulous patients who will receive two implants in the premolar area. Patients will be randomly assigned to two groups: Group A will receive metal bar overlays, and Group B will receive Peek bar overlays. The patients will be evaluated at baseline,one month ,6 month and 12 month The following parameters will be evaluated:
- Wear of nylon cap: The wear of the nylon cap will be evaluated using a digital microscope at each follow-up visit.
- Patient satisfaction: Patients will be asked to rate their satisfaction with the overdentureResults: Metal group showed significantly higher roughness and volumetric changes than PEEK regarding baseline, after 3 months, after 6 months, and after 9 months. and there was insignificant difference between them after 12 months as P=0.11.Patient satisfaction scores were significantly higher in the PEEK group, particularly in retention, stability, comfort, and speech domains at both six months and one year (p = 0.04). on a visual analogue scale (VAS) at each follow-up visit.
详细描述
Forty-six individuals were diagnosed at the outpatient clinic of Removable prosthodontic department at Cairo university and MTI university. From this group, 20 completely edentulous participants of both males and females aged 50 to 60 years were selected based on specific inclusion and exclusion criteria. Each participant provided written consent before this study used their treatment-related radiography data. Ethics committee approval for the study was obtained from the Research Ethics Committee (REC) of the Faculty of Dental Medicine Cairo University, with the reference number REC (No 94/23). The implemented radiation protection methods were in accordance with established guidelines.
Patient selection All the patient involved in the study, they should have inclusion criteria as good bone quantity and quality especially in the anterior interforaminal region as detected by CBCT and sufficient inter-arch space, minimally 12-14 mm from the ridge to the occlusal plane. The diabetic patient or patient received radiation therapy, or with parafunctional habits, and smokers should be excluded from the study.
Diagnostic and pre-operative prosthetic preparation Following the prosthetic driven implant placement protocol, all the Eligible patients already had complete dentures, their dentures were checked for adaptation, fit, stability, and occlusion. And the other patients were not wearing upper and lower complete dentures , a new denture were fabricated .
Preliminary alginate impressions (Zhermack SpA ) using a perforated stock tray were recorded, Impressions were then poured into dental stone to obtain the diagnostic model. Occlusion blocks were constructed over the diagnostic models, followed by bite registration, try-in, then the inter arch space availability for the bar was evaluated on the casts using the putty-silicon-index (Kettenbach GmbH and Co. KG ) around the artificial teeth , a minimum 13-14 mm of vertical space is required for bar-retained overdentures and finally upper and lower denture (Acrostone Dental and Medical Supplie) was delivered . Radiographic stents were fabricated as a duplicate from the fabricated patient mandibular denture with radiopaque markers (gutta percha ,Meta Dental Corp Glendale, NY ) in the centre of the teeth to guide implant positioning.
The patient was scanned CBCT while wearing the radiographic stent in the proper seating position
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
statistician
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good bone quantity and quality especially in the anterior interforaminal region as detected by CBCT and sufficient inter-arch space, minimally 12-14 mm from the ridge to the occlusal plane
排除标准
- •diabetic patient or patient received radiation therapy, or with parafunctional habits, and smokers should be excluded from the study
结局指标
主要结局
attachment clip wear
时间窗: base line ,3,6 and12 month
Plastic clip wear and roughness were analyzed on overdenture insertion and after 3,6,9 month and 1 year of clinical usage in a 3D-surface analyzer system.27Fitting surface of denture with the nylon clip were photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X.The images were recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images were cropped to 350 x 400 pixels using Microsoft office picture manager to standardize area of roughness measurement. WSxM software used for measure the average of heights of volumetric changes and surface roughness which expressed in μm, 28 a 3D image of the surface plastic clip was created ready for a 3-dimensional geometric analysis by the using a digital image analysis system (Image J 1.43U, National Institute of Health, USA). The intact unworn surface used as a reference.
次要结局
- patient satisfaction(base line ,3,6 and12 month)
研究者
Doaa Amr Heshmat
Associate professor ,Cairo university ,Faculty of dentistry
Cairo University