Oral Health-Related Quality of Life and Retention in Digitally Versus Conventionally Fabricated Flexible Removable Partial Dentures in Maxillary Class III Modification 1 Patients: A Cross-over Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Retention of a removable partial denture
研究概览
简要总结
This study aims to compare oral health-related quality of life and retention between digitally- fabricated temporary flexible RDPs and conventionally-fabricated temporary flexible RDPs.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maxillary Class III, modification I partially edentulous patients that enables measuring the retention values intraorally without denture rotation.
- •Fully dentulous or partially edentulous opposing mandibular arch.
- •Patients that require temporary partial dentures for aesthetic reasons or as an interim denture during mouth rehabilitation treatment or after implant placement.
- •Age range (30-55 years).
- •Cooperative patients that are willing to attend all follow-up periods.
- •Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
- •Patients with healthy abutments and healthy periodontium and no more than grade I mobility.
排除标准
- •Patients with Parkinson's disease
- •Patients with xerostomia.
- •Patients with a history of allergy to dentures made of resins.
- •Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
- •Patients with large irregular bony exostosis.
- •Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
研究组 & 干预措施
3D-printed and digitally designed temporary flexible maxillary removable partial denture .
干预措施: 3D-printed and digitally designed temporary flexible maxillary removable partial denture (Procedure)
The conventional heat pressing temporary flexible maxillary removable partial denture
干预措施: The conventional heat pressing temporary flexible maxillary removable partial denture (Procedure)
结局指标
主要结局
Retention of a removable partial denture
时间窗: Baseline and 6 months
The retention will be measured using Digital Force Gauge attached to the denture polished surface while the patient is in supine position
Oral health-related quality of life.
时间窗: Baseline and 6 months
Oral health impact profile (OHIP 14) questionnaire will be used to asses the oral health-related quality of life
次要结局
未报告次要终点
研究者
Medhat Sameh Shehata Abdelaziz
PHD student in prosthodontics department
Cairo University