Conventional versus 3D-printed surgical obturators for repairing upper jaw (maxillary) defects
Comparison of Patient Satisfaction and Prosthetic Complications Between Conventional Immediate Surgical Obturators and 3D-printed Immediate Surgical Obturators With Enhanced Retention
This trial will test whether 3D‑printed immediate surgical obturators give better comfort and fewer complications than conventional obturators for people having part of their upper jaw removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 36 Years to 68 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT07079163 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 24 patients with acquired maxillary defects after maxillectomy and randomly assign them to one of three immediate surgical obturator designs: conventional clasp-and-wire obturators, resin 3D‑printed obturators with printed clasps and palatal screws, or metallic 3D‑printed obturators with metal clasps and palatal screws. Digital workflows using intraoral scanning and CBCT are used to design and fabricate the 3D‑printed devices, while conventional obturators are made by manual methods. Patient‑reported outcomes will be measured with the Obturator Functioning Scale (OFS) and clinical follow‑up will record complications such as discomfort, poor retention, and mucosal irritation. The trial compares patient satisfaction and prosthetic complication rates across the three approaches to see if digital fabrication and enhanced retention improve early postoperative function.
Who should consider this trial
Good fit: Ideal candidates are adults referred to the Maxillofacial Prosthodontic Unit who are scheduled for maxillectomy with sufficient remaining dentition to retain an obturator.
Not a fit: Patients who are not physically fit for surgery or who lack adequate remaining teeth for obturator retention are unlikely to benefit from this work.
Why it matters
Potential benefit: If successful, the 3D‑printed obturators could provide better fit, improved retention, greater comfort, and fewer prosthetic complications for patients after maxillectomy.
How similar studies have performed: Small case series and pilot reports suggest 3D‑printed and digitally planned obturators can improve fit and workflow, but randomized comparative data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients indicated for maxillectomy with the remaining number of teeth * Referral to Maxillofacial Prosthodontic Unit, Mansoura University Exclusion Criteria: * contraindication to surgery (not physically fit to underwent surgery)
Where this trial is running
Al Mansurah
- Maxillofacial Prosthodontic Unit, Faculty of Dentistry, Mansoura University — Al Mansurah, Egypt (Recruiting)
Study contacts
- Study coordinator: Fatma F Mahanaa, phD
- Email: fatmamahanna@mans.edu.eg
- Phone: +201006863040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.