Laser-sintered Removable Partial Dentures: a Crossover Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean of patient satisfaction measured by McGill Denture Satisfaction Survey using visual analog scale from 0-100
研究概览
简要总结
Removable partial dentures (RPDs) are traditionally fabricated by lost-wax casting technique, a time-consuming and very laborious manual technique. Recently, fabricating removable partial dentures using computer designing and laser sintering techniques have been introduced. The purpose of this study was to evaluate the patient satisfaction with new computer-generated removable partial dentures and compare it to the traditional removable partial dentures.
详细描述
Patients seeking Removable partial dentures in the undergraduate clinic at McGill University were asked to participate in the study. Patients were treated by undergraduate students under the supervision of expert prosthodontists. Both the dentists treating the case and the patients were blinded to the type of RPD used. The Principal investigator was responsible for preparing the laboratory prescriptions and sending the final impressions to the dental lab in order to assure blinding of the patient and the treating dentists.
Patients were treated according to standardized clinical procedures. Both dentures were fabricated from one master cast to ensure standardization. The cast was scanned digitally to fabricate the laser-sintered dentures, and then was used to fabricate the cast dentures traditionally using lost-wax casting technique. For each patient, two dentures were fabricated from one final impression; one by casting technique and the other by laser-sintering. Patients were given randomly one denture first and followed-up for 1, 2 and 4 weeks. Then, they were given the second denture and followed-up again. At each follow-up visit, patients filled McGill Denture Satisfaction Instrument. At the end of the study patients were asked which denture they prefer to keep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •partially edentulous
- •have adequate space for regularly sized prosthetic teeth and metal frame(s)
- •be able to maintain adequate oral hygiene and clean their dentures; do not have major systemic health problems that could interfere with general oral health
- •have an adequate understanding of written and spoken English or French
- •be capable of giving written informed consent and fill out questionnaires
排除标准
- •there is a lack of minimum interocclusal space to accommodate a metal frame and acrylic material
- •they have acute or chronic symptoms of parafunctional disorders
- •they have inflammatory mucosal conditions such as lichen planus, progressive periodontitis or others
- •they have a history of radiation therapy to the orofacial region
- •there are health conditions that may jeopardize the treatment, such as alcoholism,
- •they are taking any phenytoin (Dilantin), cortisone or insulin
- •they have a severe/serious illness that requires frequent hospitalization
- •they have impaired cognitive or motor function
- •they are unable to return for evaluations/study recalls
研究组 & 干预措施
cast removable partial denture
patients received cast removable partial dentures fabricated using traditional lost-wax casting technique.
干预措施: cast removable partial dentures (Other)
laser-sintered removable partial denture
patients received removable partial dentures fabricated using laser-sintering.
干预措施: Laser-sintered removable partial denture (Device)
结局指标
主要结局
Mean of patient satisfaction measured by McGill Denture Satisfaction Survey using visual analog scale from 0-100
时间窗: after 4 weeks
Mean patient satisfaction in McGill Denture Satisfaction Survey was assessed in regard to 9 aspects of the dentures; general satisfaction, chewing efficiency, chewing ability, easiness to clean, stability, comfort and oral condition. Mean of patient satisfaction in each of these 9 aspects will be presented for both cast and laser-sintered dentures.
次要结局
- Number of participants who choose to keep the laser-sintered removable partial dentures(after 2 months)
研究者
Faleh Tamimi
Assistant Professor and Canada Research Chair in Translational Craniofacial Research
McGill University Health Centre/Research Institute of the McGill University Health Centre