NCT06106243招募中不适用
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
适应症
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
- Oral health-related quality of life.
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.
结局指标
主要结局
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
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
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
研究点 (1)
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