Evaluation of Patient Satisfaction After the Construction of Maxillary Obturator Prosthesis for Limited Mouth Opening in Maxillofacial Cases : Cross Over Randomized Clinical Trial

NCT ID: NCT07079384

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2025-11-12

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.

Conditions

Patient Satisfaction; Maxilofacial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

• The obturator will then be printed using Denture Base Resin and teeth.
• The printed obturator will be tried in, two magnets, one anteriorly and another posteriorly will be picked up then inserted into the patient mouth.
• The patient will be again instructed regarding the care of the prosthesis and hygiene maintenance as formerly. The patient will also be instructed to wear the obturator plate first, and once this is comfortably seated, the denture part will be inserted. During removal, the patient will be instructed to first remove the denture part gently to disengage the magnetic attraction after the obturator part as formerly instructed. The patient will be recalle

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

• The obturator will then be printed using Denture Base Resin and teeth.
• The printed obturator will be tried in, two magnets, one anteriorly and another posteriorly will be picked up then inserted into the patient mouth.
• The patient will be again instructed regarding the care of the prosthesis and hygiene maintenance as formerly. The patient will also be instructed to wear the obturator plate first, and once this is comfortably seated, the denture part will be inserted. During removal, the patient will be instructed to first remove the denture part gently to disengage the magnetic attraction after the obturator part as formerly instructed. The patient will be recalle

Interventions

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

• The obturator will then be printed using Denture Base Resin and teeth.
• The printed obturator will be tried in, two magnets, one anteriorly and another posteriorly will be picked up then inserted into the patient mouth.
• The patient will be again instructed regarding the care of the prosthesis and hygiene maintenance as formerly. The patient will also be instructed to wear the obturator plate first, and once this is comfortably seated, the denture part will be inserted. During removal, the patient will be instructed to first remove the denture part gently to disengage the magnetic attraction after the obturator part as formerly instructed. The patient will be recalle

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patient with unilateral total maxillectomy.

Free from any signs of inflammation in the defect area. The defect size is large.

Exclusion Criteria

Patient is still receiving radiation. The defect size is small. Defects result from trauma.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marwa Ahmed Aboelez, Assistant professor

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Mansoura university

Al Mansurah, , Egypt

Countries

Egypt

References

Aboelez MA, Ibrahim AM, ElSawy MA, Sayed El-Khamisy NE. Efficiency of different treatment modalities on radiation induced trismus for maxillofacial cases: a parallel randomized clinical trial. BMC Oral Health. 2025 Mar 4;25(1):332. doi: 10.1186/s12903-025-05600-7.

Reference Type: BACKGROUND

PMID: 40038715 (View on PubMed)

Other Identifiers

R.25.04.3

Identifier Type: -

Identifier Source: org_study_id