Maxillary Defect ReconstructionNCT07079163
Comparison of Conventional and 3D-printed Surgical Obturators for Maxillary Defects
A study testing Obturator block in people with Maxillary Defect Reconstruction, run by Fatma mahanna at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to compare patient satisfaction and prosthetic complications associated with three types of immediate surgical obturators used in maxillectomy patients. Read more about this study
- Who is it for?
- Ages 36 to 68 years
- Conditions the study is for
- Maxillary Defect Reconstruction
- What is being tested?
- Obturator block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2025to 31 Dec 2025
- 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 36 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients indicated for maxillectomy with the remaining number of teeth
- Referral to Maxillofacial Prosthodontic Unit, Mansoura University
Who cannot join
- contraindication to surgery (not physically fit to underwent surgery)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Maxillofacial Prosthodontic Unit, Faculty of Dentistry, Mansoura University
Al Mansurah, 35511
About this study
Official title: Comparison of Patient Satisfaction and Prosthetic Complications Between Conventional Immediate Surgical Obturators and 3D-printed Immediate Surgical Obturators With Enhanced Retention
This randomized controlled clinical trial aims to compare patient satisfaction and prosthetic complications associated with three types of immediate surgical obturators used in maxillectomy patients. A total of 24 patients with acquired maxillary defects will be randomly assigned to receive one of three obturator designs: (1) conventional obturators retained with clasps and wire, (2) resin 3D-printed obturators with printed clasps and palatal screws, or (3) metallic 3D-printed obturators with metal clasps and palatal screws.
Patient satisfaction will be evaluated using the Obturator Functioning Scale (OFS), and postoperative complications such as discomfort, lack of retention, or mucosal irritation . The study seeks to determine whether digital fabrication and enhanced retention methods improve clinical outcomes compared to traditional approaches
Read the detailed description
Maxillary defects resulting from maxillectomy procedures lead to significant impairments in speech, mastication, swallowing, and quality of life. Rehabilitation typically involves either surgical reconstruction or the use of a prosthetic obturator. Immediate surgical obturators (ISOs) are commonly used during or immediately after surgery to seal the oronasal communication and support healing. However, conventional obturators are often bulky, manually fabricated, and prone to poor retention due to tissue changes during early healing, leading to reduced patient satisfaction and increased complications.
Recent advancements in digital technology, including intraoral scanning and cone beam computed tomography (CBCT), allow for the precise design and 3D printing of obturators customized to the anticipated defect. Enhanced retention strategies such as palatal screws and custom clasps may offer improved stability, function, and comfort compared to conventional designs.
This randomized controlled clinical trial aims to evaluate and compare the clinical performance of three types of immediate surgical obturators in patients undergoing maxillectomy. A total of 24 patients with acquired maxillary defects and sufficient remaining dentition will be randomly assigned to one of three groups:
Group I: Conventional obturators retained with clasps and wire
Group II: Resin 3D-printed obturators with printed clasps and palatal screws
Group III: Metallic 3D-printed obturators with metal clasps and palatal screws
The study's primary outcome is patient satisfaction, assessed using the Obturator Functioning Scale (OFS), which evaluates prosthesis-related comfort, appearance, speech, and function. Secondary outcomes include postoperative prosthetic complications such as pain, ulceration, poor fit, or dislodgement. Assessments will be conducted during the standard healing period.
This study will provide valuable insights into the impact of digital workflows and retention techniques on the functional performance and patient-centered outcomes of obturator prostheses following maxillectomy. Ethical approval has been obtained, and all participants will provide informed consent prior to inclusion.
- Conditions
- Maxillary Defect Reconstruction
- Being tested
- Obturator block
- Keywords
- Maxillary defects, Immediate surgical obturator, patient-centered outcomes, Digital, 3D-printed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obturator blockDevice
Also called Conventional Immediate Obturator Group
A manually fabricated obturator using a preoperative maxillary cast, retained with clasps and wire. Delivered immediately after maxillectomy.
Obturator blockDevice
Also called Resin 3D-Printed Surgical Obturator
A digitally designed obturator based on fused CBCT and intraoral scan data. Fabricated in resin using 3D-printing, and retained with 3D-printed clasps and palatal screws. Delivered immediately post-maxillectomy
Obturator blockDevice
Also called Metallic 3D-Printed Surgical Obturator
A digitally designed and 3D-printed obturator fabricated in metal, using CBCT and intraoral scan data. Retention is provided by metal clasps and palatal screws. Delivered during or immediately after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Immediate Obturator Group/ obturator block | Experimental | Participants will receive a conventional immediate surgical obturator fabricated manually on a preoperative cast. Retention will be provided using clasps and/or wiring. The obturator will be inserted immediately after maxillectomy and used during the healing period. Receives: Device: Obturator block |
| Resin 3D-Printed Obturator Group | Experimental | Participants will receive a resin 3D-printed immediate surgical obturator, digitally designed using intraoral scans and CBCT data. Retention will be achieved using 3D-printed clasps and palatal screws. The obturator will be inserted immediately after surgery and monitored during healing. Receives: Device: Obturator block |
| Metallic 3D-Printed Obturator Group | Experimental | Participants will receive a metallic 3D-printed immediate surgical obturator, digitally designed using fused CBCT and digital impressions. The prosthesis will include metal clasps and palatal screws for enhanced retention. It will be delivered at surgery and assessed over the healing period. Receives: Device: Obturator block |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Patient satisfaction: measured by Obturator Functioning Scale (OFS) over 2-3 weeks.The Obturator Functioning Scale (OFS) is a patient-reported outcome measure developed to assess the functional performance and satisfaction with an obturator prosthesis, particularly in maxillectomy patients. It evaluates multiple domains related to oral rehabilitation.The OFS typically includes items addressing the following:
Appearance (Esthetics)
Speech Intelligibility
Swallowing (Deglutition)
Chewing/Mastication
Comfort
Retention and Stability
Overall Satisfaction 5-point Likert scale (e.g., 1 = very poor, 5 = excellent
Measured: 2-3 weeks after surgery
Secondary outcomes (1)
complications
Postoperative complications: type and frequency (pain, discomfort, dislodgement, etc.)
Measured: 2-3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start25 Jan 2025
- Primary completion30 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Defect ReconstructionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma mahanna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma mahanna, Mansoura University
- Investigators
- fatma mahanna, Phd, Study chair, Mansoura university, faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079163
- Sponsor's protocol ID
- A04011024RP
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Satisfaction and Prosthetic Complications Between Conventional Immediate Surgical Obturators and 3D-printed Immediate Surgical Obturators With Enhanced Retention
- ClinicalTrials.gov ID
- NCT07079163
- Acronym / sponsor ID
- A04011024RP
- Conditions
- Maxillary Defect Reconstruction
- Keywords
- Maxillary defects, Immediate surgical obturator, patient-centered outcomes, Digital, 3D-printed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fatma mahannaUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 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.
This randomized controlled clinical trial aims to compare patient satisfaction and prosthetic complications associated with three types of immediate surgical obturators used in maxillectomy patients. A total of 24 patients with acquired maxillary defects will be randomly assigned to receive one of three obturator designs: (1) conventional obturators retained with clasps and wire, (2) resin 3D-printed obturators with printed clasps and palatal screws, or (3) metallic 3D-printed obturators with metal clasps and palatal screws.
Patient satisfaction will be evaluated using the Obturator Functioning Scale (OFS), and postoperative complications such as discomfort, lack of retention, or mucosal irritation . The study seeks to determine whether digital fabrication and enhanced retention methods improve clinical outcomes compared to traditional approaches
Detailed description
Maxillary defects resulting from maxillectomy procedures lead to significant impairments in speech, mastication, swallowing, and quality of life. Rehabilitation typically involves either surgical reconstruction or the use of a prosthetic obturator. Immediate surgical obturators (ISOs) are commonly used during or immediately after surgery to seal the oronasal communication and support healing. However, conventional obturators are often bulky, manually fabricated, and prone to poor retention due to tissue changes during early healing, leading to reduced patient satisfaction and increased complications.
Recent advancements in digital technology, including intraoral scanning and cone beam computed tomography (CBCT), allow for the precise design and 3D printing of obturators customized to the anticipated defect. Enhanced retention strategies such as palatal screws and custom clasps may offer improved stability, function, and comfort compared to conventional designs.
This randomized controlled clinical trial aims to evaluate and compare the clinical performance of three types of immediate surgical obturators in patients undergoing maxillectomy. A total of 24 patients with acquired maxillary defects and sufficient remaining dentition will be randomly assigned to one of three groups:
Group I: Conventional obturators retained with clasps and wire
Group II: Resin 3D-printed obturators with printed clasps and palatal screws
Group III: Metallic 3D-printed obturators with metal clasps and palatal screws
The study's primary outcome is patient satisfaction, assessed using the Obturator Functioning Scale (OFS), which evaluates prosthesis-related comfort, appearance, speech, and function. Secondary outcomes include postoperative prosthetic complications such as pain, ulceration, poor fit, or dislodgement. Assessments will be conducted during the standard healing period.
This study will provide valuable insights into the impact of digital workflows and retention techniques on the functional performance and patient-centered outcomes of obturator prostheses following maxillectomy. Ethical approval has been obtained, and all participants will provide informed consent prior to inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Immediate Obturator Group/ obturator block | Experimental | Device: Obturator blockParticipants will receive a conventional immediate surgical obturator fabricated manually on a preoperative cast. Retention will be provided using clasps and/or wiring. The obturator will be inserted immediately after maxillectomy and used during the healing period. |
| Resin 3D-Printed Obturator Group | Experimental | Device: Obturator blockParticipants will receive a resin 3D-printed immediate surgical obturator, digitally designed using intraoral scans and CBCT data. Retention will be achieved using 3D-printed clasps and palatal screws. The obturator will be inserted immediately after surgery and monitored during healing. |
| Metallic 3D-Printed Obturator Group | Experimental | Device: Obturator blockParticipants will receive a metallic 3D-printed immediate surgical obturator, digitally designed using fused CBCT and digital impressions. The prosthesis will include metal clasps and palatal screws for enhanced retention. It will be delivered at surgery and assessed over the healing period. |
Who may qualify
- Ages
- 36 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients indicated for maxillectomy with the remaining number of teeth
- Referral to Maxillofacial Prosthodontic Unit, Mansoura University
Key exclusion criteria (1 listed)
- contraindication to surgery (not physically fit to underwent surgery)
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 |
|---|---|---|
| Obturator blockAlso: Conventional Immediate Obturator GroupA manually fabricated obturator using a preoperative maxillary cast, retained with clasps and wire. Delivered immediately after maxillectomy. | Device | Conventional Immediate Obturator Group/ obturator block |
| Obturator blockAlso: Resin 3D-Printed Surgical ObturatorA digitally designed obturator based on fused CBCT and intraoral scan data. Fabricated in resin using 3D-printing, and retained with 3D-printed clasps and palatal screws. Delivered immediately post-maxillectomy | Device | Resin 3D-Printed Obturator Group |
| Obturator blockAlso: Metallic 3D-Printed Surgical ObturatorA digitally designed and 3D-printed obturator fabricated in metal, using CBCT and intraoral scan data. Retention is provided by metal clasps and palatal screws. Delivered during or immediately after surgery. | Device | Metallic 3D-Printed Obturator Group |
Primary outcome
patient satisfaction
Time frame: 2-3 weeks after surgery
Patient satisfaction: measured by Obturator Functioning Scale (OFS) over 2-3 weeks.The Obturator Functioning Scale (OFS) is a patient-reported outcome measure developed to assess the functional performance and satisfaction with an obturator prosthesis, particularly in maxillectomy patients. It evaluates multiple domains related to oral rehabilitation.The OFS typically includes items addressing the following: Appearance (Esthetics) Speech Intelligibility Swallowing (Deglutition) Chewing/Mastication Comfort Retention and Stability Overall Satisfaction 5-point Likert scale (e.g., 1 = very poor, 5 = excellent
1 secondary outcome
complications
Time frame: 2-3 weeks after surgery
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 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Maxillary Defect Reconstruction
Not yet recruitingObservational study
Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
Maxillary Obturators, Maxillary Defect Reconstruction
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.
fatma mahanna, Phd study chair
Mansoura university, faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obturator block in people with Maxillary Defect Reconstruction, run by Fatma mahanna 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: finished, as of the sponsor's last update on 6 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 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?
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?
patient satisfaction (time frame: 2-3 weeks after surgery). 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 6 Oct 2026.