An interventional study of Digitally Fabricated Obturator Prosthesis in Maxillary Deficiency and Head and Neck Neoplasms, sponsored by Dr. Merve Benli. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Dr. Merve Benli · Not applicable, Interventional, and Other
The success of digitally fabricated obturator rehabilitation is determined not only by the prosthesis itself but also by the interaction between patient characteristics, oncologic history, prosthetic support, and three-dimensional defect complexity.
Digital data obtained during prosthesis fabrication may therefore serve a dual purpose:
to fabricate the prosthesis and to predict the patient's expected functional response.
Maxillectomy can result in substantial functional impairment because of the loss of separation between the oral and nasal cavities, altered mastication, impaired speech, nasal leakage, compromised swallowing, and changes in facial appearance. Prosthetic rehabilitation with an obturator remains an important treatment option for restoring function and quality of life in patients with acquired maxillary defects.
Advances in digital dentistry have enabled the fabrication of obturator prostheses using intraoral scanning, digital integration of conventional impressions when required, computer-aided design, and additive or subtractive manufacturing. Digital workflows may improve reproducibility, facilitate prosthesis replacement, reduce prosthesis weight through controlled hollow-bulb design, and potentially decrease chairside and laboratory time. Nevertheless, the clinical success of obturator rehabilitation is influenced not only by the fabrication method but also by the anatomical complexity of the defect, residual dentition, history of radiotherapy, xerostomia, mouth opening, available tissue support, and prosthetic retention.
Most currently available reports describing digitally fabricated obturators have focused on fabrication techniques, feasibility, individual clinical cases, or small patient cohorts. Less is known about which patient- and defect-specific characteristics predict favorable functional and patient-reported outcomes following digital obturator rehabilitation.
Traditional defect classifications, including Aramany and Brown classifications, provide clinically useful categorical descriptions but may not fully represent the three-dimensional anatomical complexity of maxillary defects. Digital workflows provide an opportunity to objectively quantify defect morphology, including defect volume, surface area, remaining palatal support, vertical extension, and residual dentition. These parameters may provide additional predictive information regarding treatment outcomes.
The present study therefore aims to prospectively evaluate clinical, functional, and patient-reported outcomes following rehabilitation with digitally fabricated definitive obturator prostheses and to determine whether digitally quantified defect morphology and other clinical variables can predict treatment response.
The primary aim of this prospective longitudinal clinical study is to identify patient-, defect-, treatment-, and prosthesis-related predictors of functional and patient-reported outcomes following rehabilitation with digitally fabricated definitive obturator prostheses in patients with acquired maxillary defects.
A secondary aim is to develop and explore a Digital Defect Complexity Index (DDCI) based on quantitative three-dimensional anatomical characteristics and determine whether this index is associated with functional improvement following obturator rehabilitation.
39 studies on the registry are indexed under Retrognathia; 8 are open to participants now.
This study's enrollment of 75 is above the median of 38 across 32 interventional studies indexed under Retrognathia.
Browse Retrognathia studies →Dr. Merve Benli is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Eligible for rehabilitation with a digitally fabricated definitive obturator prosthesis.
Able to understand and complete the required study questionnaires and functional assessments.
Willing and able to attend scheduled follow-up visits through 6 months. Able to provide written informed consent.
Exclusion Criteria:
Actively changing or incompletely healed maxillary defect. Recurrent or progressive disease requiring treatment that would interfere with prosthodontic rehabilitation or study follow-up.
Cognitive, neurologic, or medical condition preventing completion of the required study assessments.
Unable or unwilling to complete the required follow-up period.
Participants with acquired maxillary defects following partial or total maxillectomy will receive a definitive digitally fabricated obturator prosthesis using a standardized digital or hybrid digital workflow. Three-dimensional defect characteristics will be quantified to calculate the Digital Defect Complexity Index (DDCI). Participants will undergo longitudinal functional, clinical, and patient-reported outcome assessments at baseline and during follow-up through 6 months after definitive obturator delivery.
Device: Digitally Fabricated Obturator Prosthesis
A patient-specific definitive obturator prosthesis will be digitally designed and fabricated for rehabilitation of the acquired maxillary defect. Three-dimensional anatomical data will be acquired using a digital or hybrid digital workflow and used for computer-aided prosthesis design. A hollow or reduced-weight obturator design will be incorporated when clinically indicated. The definitive prosthesis will undergo standardized postprocessing, finishing, and clinical adjustment before delivery. Participants will be followed for 6 months to evaluate functional, clinical, and patient-reported outcomes. This is consistent with your protocol, which specifies digitally designed definitive obturators and permits hollow or reduced-weight designs when clinically indicated.
Also known as: Digital obturator prosthesis; CAD/CAM obturator prosthesis; digitally designed definitive obturator
Change in Obturator Functioning Scale (OFS) Score
Change in patient-reported obturator-related function from baseline to 6 months after delivery of the digitally fabricated definitive obturator prosthesis, measured using the Obturator Functioning Scale (OFS). Lower scores indicate fewer obturator-related functional difficulties.
Time frame: Baseline to 6 months after definitive obturator delivery
Change in Speech Intelligibility Percentage Score
Speech intelligibility will be assessed using standardized recorded speech samples. Participants will read a standardized word list, and recorded samples will be independently evaluated by trained listeners who are blinded to the assessment time point. Speech intelligibility will be calculated as the percentage of words correctly identified by the listeners (0%-100%). Higher scores indicate better speech intelligibility. Change in speech intelligibility will be calculated from baseline to 6 months after delivery of the digitally fabricated definitive obturator prosthesis.
Time frame: Baseline to 6 months after definitive obturator delivery
Change in Masticatory Performance Assessed Using the Mixing Ability Test (MAT)
Masticatory performance will be objectively assessed using the Mixing Ability Test (MAT). Participants will chew a standardized two-colored wax tablet for a predefined number of chewing cycles. Following chewing, the wax specimen will be flattened to a standardized thickness and digitally analyzed to quantify the degree of color mixing. Masticatory performance will be expressed as the Mixing Ability Index (MAI), with lower MAI values indicating better color mixing and therefore better masticatory performance. Change in MAI will be assessed from baseline to 6 months after delivery of the digitally fabricated definitive obturator prosthesis.
Time frame: Baseline to 6 months after definitive obturator delivery
Change in Oral Health-Related Quality of Life Assessed Using the 14-Item Oral Health Impact Profile (OHIP-14)
Change in oral health-related quality of life from baseline to 6 months after delivery of the digitally fabricated definitive obturator prosthesis, measured using the 14-item Oral Health Impact Profile (OHIP-14).
Time frame: Baseline to 6 months after definitive obturator delivery
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Dr. Merve Benli