Maxillary DeficiencyNCT07864974
Predictors of Patient-Reported Outcomes for Maxillectomy Patients
A study testing Digitally Fabricated Obturator Prosthesis in people with Maxillary Deficiency and Head and Neck Neoplasms, run by Dr. Merve Benli at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Deficiency, Head and Neck Neoplasms
- What is being tested?
- Digitally Fabricated Obturator Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2025to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older. Acquired maxillary defect resulting from partial or total maxillectomy. Primary surgical treatment completed. Healed and clinically stable maxillary defect suitable for definitive prosthodontic rehabilitation.
- 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.
Who cannot join
- Requiring only a surgical or interim obturator rather than a definitive obturator prosthesis.
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul university,Faculty of Dentistry
Fatih, Turkey, 34452
About this study
Official title: Patient-Reported Oral Health-Related Quality of Life Assessed Using the Obturator Functioning Scale
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.
Read the detailed description
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.
- Conditions
- Maxillary Deficiency, Head and Neck Neoplasms
- Being tested
- Digitally Fabricated Obturator Prosthesis
- Keywords
- Maxillectomy, Maxillary Defect, Obturator Prosthesis
- Medical subject headings
- Retrognathia, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally Fabricated Obturator ProsthesisDevice
Also called Digital obturator prosthesis; CAD/CAM obturator prosthesis; digitally designed definitive obturator
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.
| Study group | Role | What they receive |
|---|---|---|
| Digitally Fabricated Obturator Rehabilitation | Experimental | 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. Receives: Device: Digitally Fabricated Obturator Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months after definitive obturator delivery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Baseline to 6 months after definitive obturator delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start12 Aug 2025
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary DeficiencyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive rehabilitation with a digitally fabricated definitive obturator prosthesis and will be prospectively followed for 6 months. Functional, clinical, and patient-reported outcomes will be evaluated longitudinally, and three-dimensional defect characteristics will be used to develop and internally validate the Digital Defect Complexity Index (DDCI) as a predictor of treatment outcomes.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Merve Benli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Merve Benli, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864974
- Sponsor's protocol ID
- C-243690
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Oral Health-Related Quality of Life Assessed Using the Obturator Functioning Scale
- ClinicalTrials.gov ID
- NCT07864974
- Acronym / sponsor ID
- C-243690
- Conditions
- Maxillary Deficiency, Head and Neck Neoplasms
- Keywords
- Maxillectomy, Maxillary Defect, Obturator Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dr. Merve BenliUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 8 Oct 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive rehabilitation with a digitally fabricated definitive obturator prosthesis and will be prospectively followed for 6 months. Functional, clinical, and patient-reported outcomes will be evaluated longitudinally, and three-dimensional defect characteristics will be used to develop and internally validate the Digital Defect Complexity Index (DDCI) as a predictor of treatment outcomes.
| Arm | Type | Receives |
|---|---|---|
| Digitally Fabricated Obturator Rehabilitation | Experimental | Device: Digitally Fabricated Obturator ProsthesisParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older. Acquired maxillary defect resulting from partial or total maxillectomy. Primary surgical treatment completed. Healed and clinically stable maxillary defect suitable for definitive prosthodontic rehabilitation.
- 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.
Key exclusion criteria (4 listed)
- Requiring only a surgical or interim obturator rather than a definitive obturator prosthesis.
- 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.
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 |
|---|---|---|
| Digitally Fabricated Obturator ProsthesisAlso: Digital obturator prosthesis; CAD/CAM obturator prosthesis; digitally designed definitive obturatorA 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. | Device | Digitally Fabricated Obturator Rehabilitation |
Primary outcome
Change in Obturator Functioning Scale (OFS) Score
Time frame: Baseline to 6 months after definitive obturator delivery
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.
3 secondary outcomes
Change in Speech Intelligibility Percentage Score
Time frame: Baseline to 6 months after definitive obturator delivery
Change in Masticatory Performance Assessed Using the Mixing Ability Test (MAT)
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)
Time frame: Baseline to 6 months after definitive obturator delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitally Fabricated Obturator Prosthesis in people with Maxillary Deficiency and Head and Neck Neoplasms, run by Dr. Merve Benli at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Oct 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Obturator Functioning Scale (OFS) Score (time frame: Baseline to 6 months after definitive obturator delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.