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

July 14, 2025 updated by: Mansoura University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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
  • 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
Active Comparator: 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.
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
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS of pain
Time Frame: 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.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gothenburg Trismus Questionnaire (GTQ)
Time Frame: 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.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Marwa Ahmed Aboelez, Assistant professor, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

October 12, 2025

Study Completion (Estimated)

November 12, 2025

Study Registration Dates

First Submitted

July 14, 2025

First Submitted That Met QC Criteria

July 14, 2025

First Posted (Actual)

July 23, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R.25.04.3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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