A cross-over randomized control trial to evaluate the influence of obturator on oral health related quality of life made using conventional and digital method.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oral health related quality of life using OHIP 14
研究概览
简要总结
A thorough medical history will be taken at the time of recruitment. OHIP-14 questionnaire and VAS score using obturator functioning scale for their level of difficulty with various oral functions will be filled at the time of recruitment (without Prosthesis), one month after the delivery of definitive prosthesis and one month after change of their prosthesis made with an alternate method than the previous one.
Conventional Pathway:
After blocking the undercuts within the maxillary defect, a preliminary impression will be made in irreversible hydrocolloid. The plaster cast obtained will be utilised for the fabrication of the custom tray for the final impression. After the application of the compatible adhesive, an additional silicone impression will be made for the defect, residual maxilla, and teeth. The impression will be sent for the fabrication of the cast partial denture framework. Following the intra oral evaluation of its fit, jaw relation, teeth setting and final processing in heat cure polymethyl methacrylate denture base resin will be done. At the time of final prosthesis delivery, evaluation of the intra-oral fit, occlusion, and comfort will be assessed. Post- delivery instruction and review after one day, and 1 month will be done for the patient.
Digital Pathway:
CBCT will be done after recruitment of the patient. The dicom data will be converted to .stl using Mimics software. A virtual, perforated titanium framework will be designed on the computer and a 3-D printed framework will be obtained. After its intra-oral evaluation for fit and accuracy, jaw relation, teeth set up, and processing in will be done on the 3 D printed model. Evaluation of the intra oral fit, occlusion, and comfort will be done at the time of prosthesis delivery. Post-delivery instruction and review after one day, and 1 month will be reinforced.
The subjects will be asked to score their overall satisfaction and denture-related parameters 3 months after delivery of each denture. Additionally, they will be asked to choose their preferred denture type at the end of the trial.
Two obturators will be made for each patient; one made by conventional method and other by digital method. A minimum of two hundred units of maxillary prosthesis will be made for the recruited patients. High strength denture base resin will be used as a denture base and cross-linked teeth will be used for the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria:
- •Patients both males and females with age range of 18-80 years old.
- •Well healed maxillary defects resulting from the surgical resection of benign and malignant tumours of maxilla, infectious diseases, osteomyelitis, and trauma.
- •Patients with untreated cleft palate.
- •Patients who provide informed consent for the study.
排除标准
- •Exclusion criteria:
- •Maxillary defects due to recurrent malignancy
- •Completely edentulous patients
- •Patients with bilateral maxillectomy
- •Syndromic patients
- •Patients who underwent radiotherapy less than 6 months ago.
- •Pregnant patients at the time of recruitment
- •Patients not consenting for the treatment and follow-up schedule.
结局指标
主要结局
Oral health related quality of life using OHIP 14
时间窗: Baseline, 4 weeks, 8 weeks
次要结局
- Patient satisfaction(first in 4 weeks followed by 2 weeks wash out period followed by follow up in 4 weeks)
研究者
Dr Bhavita Wadhwa
Post Graduate Institute of Medical Education and Research Chandigarh