Mandible; DeformityPEEKNCT06838533
Patient Specific PEEK Versus Titanium Patient Specific Plates in The Fixation of Computer-Guided Advancement Genioplasty
A study testing computer guided advancement genioplasty in people with Mandible; Deformity, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Evaluation of polyetheretherketone (PEEK) versus titanium patient specific plates in the fixation of computer-guided advancement genioplasty. Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Mandible; Deformity
- What is being tested?
- computer guided advancement genioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2018to 1 Oct 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 17 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who are indicated to advancement genioplasty.
- Patients with completed growth.
- Physically and psychologically able to tolerate surgical procedures.
Who cannot join
- Presence of any medical conditions that contraindicate the surgical procedure.
- Any medical condition that compromises the healing and surgical outcome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Specific Polyetheretherketone (PEEK) Miniplates Versus Titanium Genioplasty Plates in The Fixation of Computer-Guided Advancement Genioplasty
Evaluation of polyetheretherketone (PEEK) versus titanium patient specific plates in the fixation of computer-guided advancement genioplasty.
Read the detailed description
Aim: Comparison between polyetheretherketone (PEEK) and titanium patient specific plates in the fixation of computer-guided advancement genioplasty.
Patients and Methods: This study included fourteen patients indicated for advancement genioplasty. Patients were assigned randomly into one of two equal groups. Group A (Control group) included seven patients who were treated by computer guided advancement genioplasty using patient specific titanium plates and Group B(Study group) involved seven patients who were treated by computer guided advancement genioplasty using patient specific PEEK plates.
- Conditions
- Mandible; Deformity
- Being tested
- computer guided advancement genioplasty
- Keywords
- Genioplasty, PEEK, Mandible deformity
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer guided advancement genioplastyProcedure or surgery
PEEK vs Titanium patient specific plates
| Study group | Role | What they receive |
|---|---|---|
| PEEK plates in Computer guided advancement genioplasty | Experimental | Study group Receives: Procedure: computer guided advancement genioplasty |
| Titanium plates in Computer guided advancement genioplasty | Experimental | Control group Receives: Procedure: computer guided advancement genioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of PEEK vs Titanium plates
Radiographic linear discrepancy in mm (Horizontal and vertical) between Pogonion and Menton position in immediate and 6 months postoperative
Measured: 6 months follow up
Secondary outcomes (3)
Patient satisfaction
Number from 1 to 5 of a 5-point Likert scale (1 very dissatisfied is minimal to 5 very satisfied is maximum)
Measured: 6 months
Cost of patient specific plated (PEEK and titanium)
Number in Egyptian pound
Measured: 6 months
Soft tissue healing
Binary answer (yes if happened or no if not happened) of clinical examination (Infection, soft tissue dehiscence and plate exposure)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start3 Mar 2018
- Primary completion2 Mar 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible; DeformityStudies 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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Mohamed Mohamed Abdelwahab, Faculty of Dental Medicine for Girls
- Investigators
- Nahed Adly, consultant, Study director, Assistant professor at faaculty of dentistry AlAzhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838533
- Sponsor's protocol ID
- ORSUR-108-2-L
- Acronym
- PEEK
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Polyetheretherketone (PEEK) Miniplates Versus Titanium Genioplasty Plates in The Fixation of Computer-Guided Advancement Genioplasty
- ClinicalTrials.gov ID
- NCT06838533
- Acronym / sponsor ID
- PEEK / ORSUR-108-2-L
- Conditions
- Mandible; Deformity
- Keywords
- Genioplasty, PEEK, Mandible deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 20 Feb 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.
Evaluation of polyetheretherketone (PEEK) versus titanium patient specific plates in the fixation of computer-guided advancement genioplasty.
Detailed description
Aim: Comparison between polyetheretherketone (PEEK) and titanium patient specific plates in the fixation of computer-guided advancement genioplasty.
Patients and Methods: This study included fourteen patients indicated for advancement genioplasty. Patients were assigned randomly into one of two equal groups. Group A (Control group) included seven patients who were treated by computer guided advancement genioplasty using patient specific titanium plates and Group B(Study group) involved seven patients who were treated by computer guided advancement genioplasty using patient specific PEEK plates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK plates in Computer guided advancement genioplasty | Experimental | Procedure: computer guided advancement genioplastyStudy group |
| Titanium plates in Computer guided advancement genioplasty | Experimental | Procedure: computer guided advancement genioplastyControl group |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who are indicated to advancement genioplasty.
- Patients with completed growth.
- Physically and psychologically able to tolerate surgical procedures.
Key exclusion criteria (2 listed)
- Presence of any medical conditions that contraindicate the surgical procedure.
- Any medical condition that compromises the healing and surgical outcome.
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 |
|---|---|---|
| computer guided advancement genioplastyPEEK vs Titanium patient specific plates | Procedure or surgery | PEEK plates in Computer guided advancement genioplasty, Titanium plates in Computer guided advancement genioplasty |
Primary outcome
Stability of PEEK vs Titanium plates
Time frame: 6 months follow up
Radiographic linear discrepancy in mm (Horizontal and vertical) between Pogonion and Menton position in immediate and 6 months postoperative
3 secondary outcomes
Patient satisfaction
Time frame: 6 months
Cost of patient specific plated (PEEK and titanium)
Time frame: 6 months
Soft tissue healing
Time frame: 6 months
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Nahed Adly, consultant study director
Assistant professor at faaculty of dentistry AlAzhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer guided advancement genioplasty in people with Mandible; Deformity, run by Faculty of Dental Medicine for Girls 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 2 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 27 Feb 2025. 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?
Stability of PEEK vs Titanium plates (time frame: 6 months follow up). 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 27 Feb 2025.