Maxillary ObturatorsNCT06403930
Accuracy of Maxillary Obturator Bulb in Maxillectomy Defects
A study testing Maxillary Obturator in people with Maxillary Obturators, run by Badr University at 1 site in Egypt.
Trial summary
Treatment of tumors in the paranasal region often requires maxillectomy procedures. While surgical reconstruction is preferred, prosthetic reconstruction using obturators becomes necessary when surgery is not feasible. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillary Obturators
- What is being tested?
- Maxillary Obturator
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2024to 16 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study enrolled participants of all genders who had defects or abnormalities involving both hard and soft palate regions.
- Participants were included if their surgical site was fully healed and they had partial tooth loss or missing teeth in the maxilla defect area.
- Only cooperative patients capable of following instructions were selected.
Who cannot join
- Individuals with temporomandibular disorders.
- uncontrolled diabetes.
- bleeding disorders.
- ongoing anticoagulant therapy.
- Patients with flabby tissues.
- sharp mandibular residual ridges.
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- heavy smoking habits.
- neuromuscular disorders.
- severe psychiatric conditions were also not eligible for the study.
- The study did not include children, with only adult participants considered.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bland-Altman Analysis of Maxillary Obturator Bulb Accuracy in Class III Brown Classification Maxillectomy Defects
Treatment of tumors in the paranasal region often requires maxillectomy procedures. While surgical reconstruction is preferred, prosthetic reconstruction using obturators becomes necessary when surgery is not feasible. Obturators separate oral and nasal cavities, restoring functions like chewing, speech, and facial aesthetics, while alleviating psychological distress. The emergence of rapid prototyping (RP) technologies since 1995 has revolutionized prosthetic construction. RP techniques like stereolithography and 3D printing enable layer-by-layer production of accurate 3D models from computer designs. Combined with imaging like CT and MRI, RP allows creation of highly precise extraoral facial prostheses. For intraoral defects, integrating 3D CAD and RP can enhance prosthetic outcomes compared to conventional gypsum models, although obtaining accurate impressions remains challenging due to factors like defect size, undercuts, and mucosal issues.
Read the detailed description
The treatment of tumors in the paranasal region often necessitates either palatal maxillectomy or radical maxillectomy procedures, which involve the surgical removal of a portion or the entire maxillary bone. While these surgical interventions are aimed at treating the underlying condition, they can result in significant functional and aesthetic deficits for the patient. In such cases, surgical and prosthetic interventions offer avenues to address these post-maxillectomy challenges, ensuring both functional and aesthetic outcomes.
Despite the advantages associated with surgical reconstruction procedures, they may not always be feasible due to the patient's overall health condition or the extent of the defect. In these situations, prosthetic reconstruction becomes an imperative solution. Temporary or permanent obturators serve as effective prosthetic devices in this context, with the primary aim of separating the oral and sinonasal cavities. This separation is crucial in preventing issues such as hypernasal speech, which occurs when air escapes through the nasal cavity during speech, and fluid leakage into the nasal cavity, which can lead to discomfort and potential health complications.
Beyond their functional role in separating the cavities, obturators play a pivotal role in restoring essential functions like chewing, swallowing, and speech. They provide support to the lips and cheeks, aiding in the restoration of facial contour and aesthetics. Moreover, these prosthetic devices contribute significantly to alleviating the social and psychological distress experienced by patients, as they help to restore a sense of normalcy and self-confidence.
The emergence of rapid prototype production technology, also known as rapid prototyping (RP) or laser-layered manufacturing, has revolutionized the creation of three-dimensional solid models. This technique, which has seen global advancement since 1995, enables the layer-by-layer production of physical models directly from computer-aided designs in a single step. Unlike traditional computer-assisted design (CAD)-computer-aided manufacturing (CAM) systems that involve material removal, rapid prototype techniques employ technologies like lasers and numerical control to build models layer by layer, facilitating the creation of intricate internal details and smooth surfaces, even in complex structures.
Various rapid prototype techniques, including stereolithography (SLA), laminated object manufacturing, selective laser sintering, fused deposition modeling, and three-dimensional printing, offer diverse options for model production. These techniques utilize different materials and layering methods but can be combined to achieve desired outcomes, making them highly versatile and adaptable to specific requirements.
Rapid prototype production techniques present a viable alternative to conventional methods for constructing facial prostheses. By utilizing computer-aided imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), and laser surface scanners, highly accurate extraoral facial prostheses can be crafted using CAD-CAM and RP technologies. These advanced techniques ensure excellent contours and tissue adaptation, resulting in prostheses that seamlessly integrate with the patient's facial features and enhance their overall appearance.
While conventional gypsum models are typically used for prosthetic rehabilitation of intraoral deformities like maxillectomy defects, the integration of 3D CAD and RP technologies can significantly enhance outcomes. A crucial aspect of creating a functional and aesthetically pleasing prosthesis lies in obtaining an accurate impression of the defect site. However, this process is often complicated by various factors, such as the properties of the impression material, the size and nature of the defect, the presence of undercuts, and the condition of remaining teeth, all of which influence the accuracy of the impression. Additionally, challenges like pain, tears, and deformations during impression removal, as well as bleeding and mucosal adhesion, further complicate the process. Limitations in mouth opening may also hinder the optimal insertion of the impression materials, further emphasizing the need for advanced techniques and materials.
- Conditions
- Maxillary Obturators
- Being tested
- Maxillary Obturator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary ObturatorDevice
Maxillary obturators are prosthetic devices used to close maxillary defects resulting from surgical removal of part or all of the maxilla bone due to conditions like tumors or congenital anomalies. They separate the oral and nasal cavities, restore speech, swallowing, and mastication functions, provide facial support, and improve aesthetics and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | PMMA bulbs on metal frameworks Receives: Device: Maxillary Obturator |
| Group II | Experimental | Injection-molded PMMA obturators. Receives: Device: Maxillary Obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root mean square
Serial 3D dental model superimposition allows for a detailed, risk-free evaluation of morphological changes in a patient's mouth over time. In this study, the accuracy and precision of five different palatal areas used for superimposing maxillary 3D digital dental casts were evaluated.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start15 May 2024
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary ObturatorsStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study evaluated the accuracy of different obturator materials using Bland-Altman analysis and assessed patient satisfaction with obturators in post-maxillectomy patients using the obturator functioning scale, addressing functional and aesthetic issues caused by maxillofacial tumor surgeries that impact patients' quality of life and social well-being.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady El Naggar, Badr University
- Investigators
- Shady Elnaggar, Principal investigator, Badr university in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403930
- Sponsor's protocol ID
- 2024-1
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bland-Altman Analysis of Maxillary Obturator Bulb Accuracy in Class III Brown Classification Maxillectomy Defects
- ClinicalTrials.gov ID
- NCT06403930
- Acronym / sponsor ID
- 2024-1
- Conditions
- Maxillary Obturators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 8 May 2024 (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.
Treatment of tumors in the paranasal region often requires maxillectomy procedures. While surgical reconstruction is preferred, prosthetic reconstruction using obturators becomes necessary when surgery is not feasible. Obturators separate oral and nasal cavities, restoring functions like chewing, speech, and facial aesthetics, while alleviating psychological distress. The emergence of rapid prototyping (RP) technologies since 1995 has revolutionized prosthetic construction. RP techniques like stereolithography and 3D printing enable layer-by-layer production of accurate 3D models from computer designs. Combined with imaging like CT and MRI, RP allows creation of highly precise extraoral facial prostheses. For intraoral defects, integrating 3D CAD and RP can enhance prosthetic outcomes compared to conventional gypsum models, although obtaining accurate impressions remains challenging due to factors like defect size, undercuts, and mucosal issues.
Detailed description
The treatment of tumors in the paranasal region often necessitates either palatal maxillectomy or radical maxillectomy procedures, which involve the surgical removal of a portion or the entire maxillary bone. While these surgical interventions are aimed at treating the underlying condition, they can result in significant functional and aesthetic deficits for the patient. In such cases, surgical and prosthetic interventions offer avenues to address these post-maxillectomy challenges, ensuring both functional and aesthetic outcomes.
Despite the advantages associated with surgical reconstruction procedures, they may not always be feasible due to the patient's overall health condition or the extent of the defect. In these situations, prosthetic reconstruction becomes an imperative solution. Temporary or permanent obturators serve as effective prosthetic devices in this context, with the primary aim of separating the oral and sinonasal cavities. This separation is crucial in preventing issues such as hypernasal speech, which occurs when air escapes through the nasal cavity during speech, and fluid leakage into the nasal cavity, which can lead to discomfort and potential health complications.
Beyond their functional role in separating the cavities, obturators play a pivotal role in restoring essential functions like chewing, swallowing, and speech. They provide support to the lips and cheeks, aiding in the restoration of facial contour and aesthetics. Moreover, these prosthetic devices contribute significantly to alleviating the social and psychological distress experienced by patients, as they help to restore a sense of normalcy and self-confidence.
The emergence of rapid prototype production technology, also known as rapid prototyping (RP) or laser-layered manufacturing, has revolutionized the creation of three-dimensional solid models. This technique, which has seen global advancement since 1995, enables the layer-by-layer production of physical models directly from computer-aided designs in a single step. Unlike traditional computer-assisted design (CAD)-computer-aided manufacturing (CAM) systems that involve material removal, rapid prototype techniques employ technologies like lasers and numerical control to build models layer by layer, facilitating the creation of intricate internal details and smooth surfaces, even in complex structures.
Various rapid prototype techniques, including stereolithography (SLA), laminated object manufacturing, selective laser sintering, fused deposition modeling, and three-dimensional printing, offer diverse options for model production. These techniques utilize different materials and layering methods but can be combined to achieve desired outcomes, making them highly versatile and adaptable to specific requirements.
Rapid prototype production techniques present a viable alternative to conventional methods for constructing facial prostheses. By utilizing computer-aided imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), and laser surface scanners, highly accurate extraoral facial prostheses can be crafted using CAD-CAM and RP technologies. These advanced techniques ensure excellent contours and tissue adaptation, resulting in prostheses that seamlessly integrate with the patient's facial features and enhance their overall appearance.
While conventional gypsum models are typically used for prosthetic rehabilitation of intraoral deformities like maxillectomy defects, the integration of 3D CAD and RP technologies can significantly enhance outcomes. A crucial aspect of creating a functional and aesthetically pleasing prosthesis lies in obtaining an accurate impression of the defect site. However, this process is often complicated by various factors, such as the properties of the impression material, the size and nature of the defect, the presence of undercuts, and the condition of remaining teeth, all of which influence the accuracy of the impression. Additionally, challenges like pain, tears, and deformations during impression removal, as well as bleeding and mucosal adhesion, further complicate the process. Limitations in mouth opening may also hinder the optimal insertion of the impression materials, further emphasizing the need for advanced techniques and materials.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study evaluated the accuracy of different obturator materials using Bland-Altman analysis and assessed patient satisfaction with obturators in post-maxillectomy patients using the obturator functioning scale, addressing functional and aesthetic issues caused by maxillofacial tumor surgeries that impact patients' quality of life and social well-being.
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: Maxillary ObturatorPMMA bulbs on metal frameworks |
| Group II | Experimental | Device: Maxillary ObturatorInjection-molded PMMA obturators. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The study enrolled participants of all genders who had defects or abnormalities involving both hard and soft palate regions.
- Participants were included if their surgical site was fully healed and they had partial tooth loss or missing teeth in the maxilla defect area.
- Only cooperative patients capable of following instructions were selected.
Key exclusion criteria (10 listed)
- Individuals with temporomandibular disorders.
- uncontrolled diabetes.
- bleeding disorders.
- ongoing anticoagulant therapy.
- Patients with flabby tissues.
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 |
|---|---|---|
| Maxillary ObturatorMaxillary obturators are prosthetic devices used to close maxillary defects resulting from surgical removal of part or all of the maxilla bone due to conditions like tumors or congenital anomalies. They separate the oral and nasal cavities, restore speech, swallowing, and mastication functions, provide facial support, and improve aesthetics and quality of life. | Device | Group I, Group II |
Primary outcome
Root mean square
Time frame: 10 days
Serial 3D dental model superimposition allows for a detailed, risk-free evaluation of morphological changes in a patient's mouth over time. In this study, the accuracy and precision of five different palatal areas used for superimposing maxillary 3D digital dental casts were evaluated.
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 17 May 2024.
- Individual participant dataSharing planned: No
Related trials for Maxillary Obturators
Not yet recruitingObservational study
Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
Maxillary Obturators, Maxillary Defect Reconstruction
Active, not recruiting
Evaluation of Patient Satisfaction After the Construction of Maxillary Obturator Prosthesis for Limited Mouth Opening in Maxillofacial Cases : Cross Over Randomized Clinical Trial
Patient Satisfaction, Maxilofacial
Recruiting
Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients
Maxillary Diseases
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.
Shady Elnaggar principal investigator
Badr university in Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary Obturator in people with Maxillary Obturators, run by Badr University 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 3 inclusion and 10 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 17 May 2024. 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?
Root mean square (time frame: 10 days). 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 17 May 2024.