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

NCT07079384 | Active Not Recruiting DMC

• 1 other identifier: R.25.04.3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction; Maxilofacial

Keywords

maxillofacial cases; limited mouth opening; obturator

Outcome Measures

Primary Outcomes (1)

• VAS of pain

  1-The patients used a visual analogue scale (VAS) to self-assess their level of pain, with 10 representing the most severe pain.

  six months

Secondary Outcomes (1)

• Gothenburg Trismus Questionnaire (GTQ)

  six months

Study Arms (2)

patients will receive obturator fabricated by the conventional method

ACTIVE COMPARATOR

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.

Other: 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

patients will receive obturator fabricated by the digital method

ACTIVE COMPARATOR

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.

Other: 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

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 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 conventional method; patients will receive obturator fabricated by the digital method

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with unilateral total maxillectomy.
• Free from any signs of inflammation in the defect area. The defect size is large.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40038715 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marwa Ahmed Aboelez, Assistant professor

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: May 12, 2025
• Primary Completion: October 12, 2025
• Study Completion: November 12, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)