Evaluation of Patient Comfort and Satisfaction After the Construction of Maxillary Obturator Prosthesis for Limited Mouth Opening in Maxillofacial Cases With Different Approaches: Cross Over Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- VAS of pain
研究概览
简要总结
A patient's quality of life is frequently negatively impacted by oral cancer, which is a serious condition. Treatment for oral cancer, which includes radiation, chemotherapy, and surgery, can result in several oral complications. The risk of impression material becoming lodged in undercuts and the challenges in retrieving the material would be inconvenient for both the patient and the dentist. Therefore, a digital pathway was chosen for the prosthesis fabrication process So, the present study aims to investigate the patient comfort and satisfaction after the construction of maxillary interim obturator for radiation-induced trismus in maxillofacial cases with different approaches: conventional and digital fabrication processes.
详细描述
A patient's quality of life is frequently negatively impacted by oral cancer, which is a serious condition. Treatment for oral cancer, which includes radiation, chemotherapy, and surgery, can result in several oral complications, including trismus, xerostomia, dysgeusia, odontogenic infections, and osteoradionecrosis.
Aim: the present study aims to investigate the patient comfort and satisfaction after the construction of maxillary interim obturator for radiation-induced trismus in maxillofacial cases with different approaches: conventional and digital fabrication processes.
Methodology: The present crossover study will be conducted on 30 maxillofacial patients with maxillary defect with limited mouth opening, aged between 50 -65 years, will be selected for the study from the Maxillofacial clinic of the Prosthodontic Department, Faculty of Dentistry, Mansoura University.A preliminary impression of the maxillary defect will be made with a high-viscosity irreversible hydrocolloid, covering all the margins of the defect and blocking all unfavorable undercuts with wet gauge piece.In a simple randomized method, 15 patients will receive obturator fabricated by the digital method.The other 15 patients will receive obturator fabricated by the conventional method Patient comfort and satisfaction by visual analogue scale (VAS), and Gothenburg Trismus Questionnaire (GTQ) at follow-up periods as follows: T0 immediately after insertion of obturator, T1= three months after insertion of obturator, T2=six months after insertion of obturator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with unilateral total maxillectomy.
- •Free from any signs of inflammation in the defect area. The defect size is large.
排除标准
- •Patient is still receiving radiation. The defect size is small. Defects result from trauma.
研究组 & 干预措施
patients will receive obturator fabricated by the conventional method
Hollow bulb obturator plate (using lost salt technique) will be made over the obtained cast. The obturator will be finished & polished, and delivered to the patient.
干预措施: The patient will be instructed about wearing the prosthesis. First, seat the prosthesis in a posterior undercut, then rotate the prosthesis slightly superiorly in the defect area and engage the anteri (Other)
patients will receive obturator fabricated by the digital method
Extraoral scanning will be done for the cast and the virtual model will be generated by using the digital software and exported as a standard tessellation language (STL) file. The STL file was imported into CAD software
- The designed two parts will be exported as an STL file and upload into the 3D printer software.
干预措施: The patient will be instructed about wearing the prosthesis. First, seat the prosthesis in a posterior undercut, then rotate the prosthesis slightly superiorly in the defect area and engage the anteri (Other)
结局指标
主要结局
VAS of pain
时间窗: six months
1-The patients used a visual analogue scale (VAS) to self-assess their level of pain, with 10 representing the most severe pain.
次要结局
- Gothenburg Trismus Questionnaire (GTQ)(six months)