Facial AsymmetryNCT05310149
Measuring the Influence of Maxillary Obturator Prosthesis on Facial Morphology in Patient With Unilateral Maxillary Defects Using Stereophotogrammetry
A study testing Prosthetic intervention with maxillary obturator prosthesis in people with Facial Asymmetry, run by Cairo University at 1 site in Egypt.
Trial summary
Functional rehabilitation and quality of life after maxillofacial surgery have been emphasized in recent years. It depends mainly on outcomes of maxillofacial reconstruction and rehabilitation involving functions, esthetics, psychology acceptance and resocialization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Asymmetry
- What is being tested?
- Prosthetic intervention with maxillary obturator prosthesis
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2022to 1 Jan 2023
- 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
- adult patient of both sexes, 6 months after partial maxillectomy with good periodontal condition of remaining tooth especially abutment tooth.
Who cannot join
- patient with history of radiotherapy, bad oral hygiene patient with tumor recurrence, patient with mental instability, patient with systemic disorders like uncontrolled diabetes, compromised heart function
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hoor Nafade
Zagazig
Hoor Nafae, 00201006268582
About this study
Functional rehabilitation and quality of life after maxillofacial surgery have been emphasized in recent years. It depends mainly on outcomes of maxillofacial reconstruction and rehabilitation involving functions, esthetics, psychology acceptance and resocialization.
Tooth loss, alveolar and maxillary bone resorption or changes of the hard palate cause facial asymmetry in patient with maxillofacial surgery. The facial soft tissue over the defect become recessed as a result of loss of lip and buccal support which lead to decrease the quality of life and psychological disorders. Prosthetic intervention with maxillary obturator prosthesis is necessary to restore the contours of the resected palate and to recreate the functional separation of the oral cavity and sinus and nasal cavities. The purpose of this study is to investigate the influence of maxillary obturator on facial morphology in patient with unilateral maxillary defect by using 3 dimensional digital stereophotogrammetry compared to the intact side of the same patient
- Conditions
- Facial Asymmetry
- Being tested
- Prosthetic intervention with maxillary obturator prosthesis
- Medical subject headings
- Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic intervention with maxillary obturator prosthesisDevice
Prosthetic intervention with maxillary obturator prosthesis is necessary to restore the contours of the resected palate and to recreate the functional separation of the oral cavity and sinus and nasal cavities. Followings are the objectives of maxillary obturator Restoration of esthetics or cosmetic appearance of the patient, Restoration of function, Protection of tissues, Therapeutic or healing effect and psychological therapy.
| Study group | Role | What they receive |
|---|---|---|
| obturator group(unilalateral maxillary defect) | Experimental | Prosthetic intervention with maxillary obturator prosthesis is necessary to restore the contours of the resected palate and to recreate the functional separation of the oral cavity and sinus and nasal cavities. Followings are the objectives of maxillary obturator Restoration of esthetics or cosmetic appearance of the patient, Restoration of function, Protection of tissues, Therapeutic or healing effect and psychological therapy. Receives: Device: Prosthetic intervention with maxillary obturator prosthesis |
| Control group | No intervention | intact side of the same patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial morphology
3 dimensional digital stereophotogrammetry compared to the intact side of the same patient.
Measured: after 6 months of maxillofacial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start7 Jan 2022
- Primary completion15 Oct 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AsymmetryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoor Nafae, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310149
- Sponsor's protocol ID
- 7122
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Influence of Maxillary Obturator Prosthesis on Facial Morphology in Patient With Unilateral Maxillary Defects Using Stereophotogrammetry
- ClinicalTrials.gov ID
- NCT05310149
- Acronym / sponsor ID
- 7122
- Conditions
- Facial Asymmetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 4 Apr 2022 (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.
Functional rehabilitation and quality of life after maxillofacial surgery have been emphasized in recent years. It depends mainly on outcomes of maxillofacial reconstruction and rehabilitation involving functions, esthetics, psychology acceptance and resocialization.
Tooth loss, alveolar and maxillary bone resorption or changes of the hard palate cause facial asymmetry in patient with maxillofacial surgery. The facial soft tissue over the defect become recessed as a result of loss of lip and buccal support which lead to decrease the quality of life and psychological disorders. Prosthetic intervention with maxillary obturator prosthesis is necessary to restore the contours of the resected palate and to recreate the functional separation of the oral cavity and sinus and nasal cavities. The purpose of this study is to investigate the influence of maxillary obturator on facial morphology in patient with unilateral maxillary defect by using 3 dimensional digital stereophotogrammetry compared to the intact side of the same patient
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obturator group(unilalateral maxillary defect) | Experimental | Device: Prosthetic intervention with maxillary obturator prosthesisProsthetic intervention with maxillary obturator prosthesis is necessary to restore the contours of the resected palate and to recreate the functional separation of the oral cavity and sinus and nasal cavities. Followings are the objectives of maxillary obturator Restoration of esthetics or cosmetic appearance of the patient, Restoration of function, Protection of tissues, Therapeutic or healing effect and psychological therapy. |
| Control group | No intervention | –intact side of the same patient |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult patient of both sexes, 6 months after partial maxillectomy with good periodontal condition of remaining tooth especially abutment tooth.
Key exclusion criteria (1 listed)
- patient with history of radiotherapy, bad oral hygiene patient with tumor recurrence, patient with mental instability, patient with systemic disorders like uncontrolled diabetes, compromised heart function
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 |
|---|---|---|
| Prosthetic intervention with maxillary obturator prosthesisProsthetic intervention with maxillary obturator prosthesis is necessary to restore the contours of the resected palate and to recreate the functional separation of the oral cavity and sinus and nasal cavities. Followings are the objectives of maxillary obturator Restoration of esthetics or cosmetic appearance of the patient, Restoration of function, Protection of tissues, Therapeutic or healing effect and psychological therapy. | Device | obturator group(unilalateral maxillary defect) |
Primary outcome
Facial morphology
Time frame: after 6 months of maxillofacial surgery
3 dimensional digital stereophotogrammetry compared to the intact side of the same patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic intervention with maxillary obturator prosthesis in people with Facial Asymmetry, run by Cairo 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 1 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: status not confirmed, as of the sponsor's last update on 4 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hoor Nafae (00201006268582, Hoor.mahmoud@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial morphology (time frame: after 6 months of maxillofacial 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 4 Apr 2022.