Patient SatisfactionNCT07079384
Evaluation of Patient Satisfaction After the Construction of Maxillary Obturator Prosthesis for Limited Mouth Opening in Maxillofacial Cases : Cross Over Randomized Clinical Trial
A study testing 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 in people with Patient Satisfaction and Maxilofacial, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Patient Satisfaction, Maxilofacial
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2025to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with unilateral total maxillectomy.
- Free from any signs of inflammation in the defect area. The defect size is large.
Who cannot join
- Patient is still receiving radiation. The defect size is small. Defects result from trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- 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
- Keywords
- maxillofacial cases, limited mouth opening, obturator
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 anteriOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (1)
Gothenburg Trismus Questionnaire (GTQ)
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start12 May 2025
- Primary completion12 Oct 2025 (estimated)
- Study completion12 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwa Ahmed Aboelez, Assistant professor, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079384
- Sponsor's protocol ID
- R.25.04.3
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40038715
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07079384
- Acronym / sponsor ID
- R.25.04.3
- Conditions
- Patient Satisfaction, Maxilofacial
- Keywords
- maxillofacial cases, limited mouth opening, obturator
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 12 Oct 2025 (estimated)
- Study completion
- 12 Nov 2025 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients will receive obturator fabricated by the conventional method | Active comparator | 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 anteriHollow 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. |
| patients will receive obturator fabricated by the digital method | Active comparator | 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 anteriExtraoral 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. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with unilateral total maxillectomy.
- Free from any signs of inflammation in the defect area. The defect size is large.
Key exclusion criteria (1 listed)
- Patient is still receiving radiation. The defect size is small. Defects result from trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | patients will receive obturator fabricated by the conventional method, patients will receive obturator fabricated by the digital method |
Primary outcome
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.
1 secondary outcome
Gothenburg Trismus Questionnaire (GTQ)
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 40038715Aboelez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Ahmed Aboelez, Assistant professor principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Patient Satisfaction and Maxilofacial, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS of pain (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07079384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.