Evaluation of Open-face Maxillary Complete Denture for Patients With Prominent Premaxilla. Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Denture retention
研究概览
简要总结
The aim of the present study was to evaluate open faced maxillary complete denture with soft acryl resin wing versus conventional heat cured maxillary complete denture regarding the retention and patient satisfaction.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completely edentulous male patients.
- •Patients having had no previous complete dentures
- •Patients with well-developed edentulous ridge with proclined premaxilla covered with healthy firm mucosa
- •Patients with normal Angle Class 1 maxillomandibular relationship
排除标准
- •Patients with resorbed ridges
- •Patients with xerostomia and patients undertaking medications that affect salivary flow (e.g., diuretics). Similarly, patients with systemic diseases that may affect the amount or consistency of saliva (e.g., uncontrolled diabetes mellitus).
研究组 & 干预措施
Conventional denture
干预措施: Conventional denture (Device)
maxillary open-faced denture
干预措施: Maxillary open-faced denture (Device)
结局指标
主要结局
Denture retention
时间窗: up to 45 days
Evaluated using a universal testing machine to exert a vertical dislodging force on the denture. A stainless-steel loop was attached to the geometric center of the denture using autopolymerizing acrylic resin. The center of the labial frenum (point A) and the hamular notches (points B\&C) were located in the denture base. The distance halfway between points B and C was measured, and the location was marked on the posterior border of the denture base (point D). Half the distance between points A and D was marked as the denture base center (point E). A force transmission device was used to transmit the dislodging vertical force from the universal testing machine to the denture. A facebow was used to set the Frankfort plane of the patient parallel to the floor. After orienting the participant to the testing machine, it was set to exert a dislodging force at a rate of 50 mm/min. The test was repeated 3 times for each denture and the mean was calculated.
Patient satisfaction with esthetics
时间窗: up to 45 days
Participant satisfaction with esthetics was evaluated by using a Visual Analogue Scale (VAS). The level of satisfaction was indicated as a sign on a 10 cm VAS, labeled with (not at all satisfied) at the zero end with (completely satisfied) at the other end. The distance (mm) between the zero point and the sign marked by the patient on the 10-cm-line was measured and expressed in percentage.
Patient satisfaction with comfort
时间窗: up to 45 days
Participant satisfaction with comfort was evaluated by using a Visual Analogue Scale (VAS). The level of satisfaction was indicated as a sign on a 10 cm VAS, labeled with (not at all satisfied) at the zero end with (completely satisfied) at the other end. The distance (mm) between the zero point and the sign marked by the patient on the 10-cm-line was measured and expressed in percentage.
次要结局
未报告次要终点
研究者
haitham ahmed hassan ismail
Assistant Lecturer of Prosthodontics
Alexandria University