Comparison of Patient Satisfaction and Prosthetic Complications Between Conventional Immediate Surgical Obturators and 3D-printed Immediate Surgical Obturators With Enhanced Retention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- patient satisfaction
研究概览
简要总结
This randomized controlled clinical trial aims to compare patient satisfaction and prosthetic complications associated with three types of immediate surgical obturators used in maxillectomy patients. A total of 24 patients with acquired maxillary defects will be randomly assigned to receive one of three obturator designs: (1) conventional obturators retained with clasps and wire, (2) resin 3D-printed obturators with printed clasps and palatal screws, or (3) metallic 3D-printed obturators with metal clasps and palatal screws.
Patient satisfaction will be evaluated using the Obturator Functioning Scale (OFS), and postoperative complications such as discomfort, lack of retention, or mucosal irritation . The study seeks to determine whether digital fabrication and enhanced retention methods improve clinical outcomes compared to traditional approaches
详细描述
Maxillary defects resulting from maxillectomy procedures lead to significant impairments in speech, mastication, swallowing, and quality of life. Rehabilitation typically involves either surgical reconstruction or the use of a prosthetic obturator. Immediate surgical obturators (ISOs) are commonly used during or immediately after surgery to seal the oronasal communication and support healing. However, conventional obturators are often bulky, manually fabricated, and prone to poor retention due to tissue changes during early healing, leading to reduced patient satisfaction and increased complications.
Recent advancements in digital technology, including intraoral scanning and cone beam computed tomography (CBCT), allow for the precise design and 3D printing of obturators customized to the anticipated defect. Enhanced retention strategies such as palatal screws and custom clasps may offer improved stability, function, and comfort compared to conventional designs.
This randomized controlled clinical trial aims to evaluate and compare the clinical performance of three types of immediate surgical obturators in patients undergoing maxillectomy. A total of 24 patients with acquired maxillary defects and sufficient remaining dentition will be randomly assigned to one of three groups:
Group I: Conventional obturators retained with clasps and wire
Group II: Resin 3D-printed obturators with printed clasps and palatal screws
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 36 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients indicated for maxillectomy with the remaining number of teeth
- •Referral to Maxillofacial Prosthodontic Unit, Mansoura University
排除标准
- •contraindication to surgery (not physically fit to underwent surgery)
结局指标
主要结局
patient satisfaction
时间窗: 2-3 weeks after surgery
Patient satisfaction: measured by Obturator Functioning Scale (OFS) over 2-3 weeks.The Obturator Functioning Scale (OFS) is a patient-reported outcome measure developed to assess the functional performance and satisfaction with an obturator prosthesis, particularly in maxillectomy patients. It evaluates multiple domains related to oral rehabilitation.The OFS typically includes items addressing the following: Appearance (Esthetics) Speech Intelligibility Swallowing (Deglutition) Chewing/Mastication Comfort Retention and Stability Overall Satisfaction 5-point Likert scale (e.g., 1 = very poor, 5 = excellent
次要结局
- complications(2-3 weeks after surgery)
研究者
Fatma mahanna
Assistant professor of prosthodontics
Mansoura University