Effect of Two Impression Techniques on Retention of Maxillary Complete Denture in Pakistani Population: A Double-blinded Crossover Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Retention of maxillary denture using digital force meter
研究概览
简要总结
The primary objective of this protocol is to compare retention in maxillary complete dentures using single-versus two-step Poly-vinyl Siloxane (PVS) impressions in edentulous patients at denture delivery. Secondary objectives include assessing patient satisfaction with impression methods and denture satisfaction after a two-month adaptation and comparing post-delivery adjustment visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderately resorbed maxillary alveolar ridge
- •Patients with bimaxillary edentulous arches
- •Patients aged between 35 to 85 years willing to participate in the study
- •Patients who could be available for follow up visits
排除标准
- •Patients with palatal torus or bony exostoses or severe undercuts in the maxillary arch
- •Patients with uncontrolled diabetes, osteoporosis, osteomalacia and osteopenia
- •Patients with xerostomia
- •Patients with mucosa covering the denture bearing area with signs of inflammation, ulceration, or hyperplasia.
- •Patients undergoing radiotherapy or chemotherapy or maxillofacial surgery
- •Patients suffering from maxillofacial trauma
- •Patients with neuromuscular disorders
- •Patients with clinical signs and symptoms of temporomandibular joint dysfunction
- •Patients with highly resorbed maxillary ridge and/ or flabby ridge
- •Patient with hypersensitivity to silicone materials
结局指标
主要结局
Retention of maxillary denture using digital force meter
时间窗: At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)
Three readings will be taken for each maxillary denture using digital force meter, and an average will be calculated in units for Newton (N) or Kg.m/s2.
次要结局
- Denture satisfaction using the Denture Satisfaction (DS) questionnaire.(At 2 months)
- Patient satisfaction with impression methods via the Burdens in Dental Impression-Making Questionnaire (BiDIM-Q)(At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days))
研究者
Syed Murtaza Raza Kazmi
Associate Professor
Aga Khan University