Evaluation of Patient Satisfaction After the Construction of Maxillary Obturator Prosthesis for Limited Mouth Opening in Maxillofacial Cases : Cross Over Randomized Clinical Trial
- Conditions
- Patient SatisfactionMaxilofacial
- Registration Number
- NCT07079384
- Lead Sponsor
- Mansoura University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Patient with unilateral total maxillectomy.
Free from any signs of inflammation in the defect area. The defect size is large.
Patient is still receiving radiation. The defect size is small. Defects result from trauma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method VAS of pain 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.
- Secondary Outcome Measures
Name Time Method Gothenburg Trismus Questionnaire (GTQ) six months The GTQ seems to be the most reliable tool for measuring trismus that is now available since a more comprehensive assessment of trismus and its treatment effects requires a multidimensional, self-administered, trismus-specific measure, which is what the GTQ offers. Its wider applicability would allow for consistent recording of trismus-related issues and a chance to get patient feedback on treatment results. The updated GTQ version had 13 items spread over three domains: eating restriction (4 items), jaw-related issues (6 items), and muscular stress (3 items). Scores on the calculated scale vary from 0 to 100.
Trial Locations
- Locations (1)
Mansoura university
🇪🇬Mansoura, Egypt
Mansoura university🇪🇬Mansoura, Egypt