Temporal HollowingNCT05240963
Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap
A study testing Temporal PEEK implant in people with Temporal Hollowing, run by Cairo University at 1 site in Egypt.
Trial summary
Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Temporal Hollowing
- What is being tested?
- Temporal PEEK implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 30 Apr 2021
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.
For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.
Read the detailed description
Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.
For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.
- Conditions
- Temporal Hollowing
- Being tested
- Temporal PEEK implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal PEEK implantProcedure or surgery
Temporal PEEK implant to reconstruct temporal fossa after temporalis muscle transfer
| Study group | Role | What they receive |
|---|---|---|
| PEEK implant | Experimental | Temporal PEEK implant to prevent temporal hollowing after temporalis muscle transfer Receives: Procedure: Temporal PEEK implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's satisfaction
patient's satisfaction using five points Likert scale
Measured: 3 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Aug 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporal HollowingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240963
- Sponsor's protocol ID
- OMFS-19715
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali S, Abdel Aziz O, Ahmed M. Patient-specific PEEK implants for immediate restoration of temporal fossa after maxillary reconstruction with temporalis muscle flap. Maxillofac Plast Reconstr Surg. 2022 May 7;44(1):20. doi: 10.1186/s40902-022-00348-4.
PubMed 35524015
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap
- ClinicalTrials.gov ID
- NCT05240963
- Acronym / sponsor ID
- OMFS-19715
- Conditions
- Temporal Hollowing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 15 Feb 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.
Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.
For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.
Detailed description
Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.
For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEK implant | Experimental | Procedure: Temporal PEEK implantTemporal PEEK implant to prevent temporal hollowing after temporalis muscle transfer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Temporal PEEK implantTemporal PEEK implant to reconstruct temporal fossa after temporalis muscle transfer | Procedure or surgery | PEEK implant |
Primary outcome
patient's satisfaction
Time frame: 3 weeks postoperative
patient's satisfaction using five points Likert scale
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 15 Feb 2022.
- Derived from this study: PubMed 35524015Ali S, Abdel Aziz O, Ahmed M. Patient-specific PEEK implants for immediate restoration of temporal fossa after maxillary reconstruction with temporalis muscle flap. Maxillofac Plast Reconstr Surg. 2022 May 7;44(1):20. doi: 10.1186/s40902-022-00348-4.
- Individual participant dataSharing planned: No
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 Temporal PEEK implant in people with Temporal Hollowing, 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: finished, as of the sponsor's last update on 15 Feb 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?
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's satisfaction (time frame: 3 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05240963, which also lists 1 linked publication.
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 15 Feb 2022.