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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07079384
Enrollment
30
Registered
2025-07-23
Start date
2025-05-12
Completion date
2025-11-12
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxilofacial, Patient Satisfaction

Keywords

maxillofacial cases, limited mouth opening, obturator

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.

Interventions

OTHERThe 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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
VAS of painsix months1-The patients used a visual analogue scale (VAS) to self-assess their level of pain, with 10 representing the most severe pain.

Secondary

MeasureTime frameDescription
Gothenburg Trismus Questionnaire (GTQ)six monthsThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026