Alveolar Ridge DeficiencyNCT07679451
Custom-Made PEEK Versus PTFE Membranes in Maxillary Alveolar Ridge Augmentation
A study testing Custom-made PEEK Membrane and PTFE Membrane in people with Alveolar Ridge Deficiency, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized controlled clinical study aims to evaluate and compare the effectiveness of custom-made polyether ether ketone (PEEK) membranes versus polytetrafluoroethylene (PTFE) membranes in guided bone regeneration for maxillary alveolar ridge augmentation in the esthetic zone. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Alveolar Ridge Deficiency
- What is being tested?
- Custom-made PEEK Membrane and PTFE Membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 45 years. Male or female participants. Presence of single or multiple missing teeth associated with vertical alveolar defects (vertical bone height less than 8 mm), horizontal alveolar defects (ridge width less than 6 mm), or combined defects in the maxillary esthetic zone requiring alveolar ridge augmentation before implant placement.
- Good oral hygiene.
Who cannot join
- Uncontrolled medical disorders contraindicating surgical intervention. Systemic diseases or medications affecting bone metabolism. Current or previous bisphosphonate therapy. History of radiotherapy. History of chemotherapy. Smokers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Dania Raad
Al Mansurah, Dakhaliya, 12345
Dania Raad, BDS, 00201063498933, raaddania7@gmail.com
About this study
Official title: Custom-Made Polyether Ether Ketone Membrane Versus Polytetrafluoroethylene Membrane in Maxillary Alveolar Ridge Augmentation: A Randomized Controlled Clinical Trial
This randomized controlled clinical study aims to evaluate and compare the effectiveness of custom-made polyether ether ketone (PEEK) membranes versus polytetrafluoroethylene (PTFE) membranes in guided bone regeneration for maxillary alveolar ridge augmentation in the esthetic zone. Thirty patients requiring ridge augmentation prior to dental implant placement will be enrolled and randomly allocated into two equal groups. Group A will receive customized PEEK membranes, while Group B will be treated with PTFE membranes. Clinical and radiographic assessments, including cone beam computed tomography (CBCT), will be performed immediately postoperatively, at 6 months, and at 12 months to evaluate volumetric, horizontal, and vertical bone gain as well as soft tissue healing and complication rates.
Read the detailed description
Guided bone regeneration (GBR) is a widely accepted technique used to reconstruct deficient alveolar ridges prior to or in conjunction with dental implant placement. This study is designed to evaluate the clinical and radiographic outcomes of two different non-resorbable barrier membranes in maxillary ridge augmentation: customized polyether ether ketone (PEEK) membranes and polytetrafluoroethylene (PTFE) membranes.
Thirty patients requiring maxillary alveolar ridge augmentation in the esthetic zone will be recruited from the Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University. Patients will be randomly allocated into two groups of equal size. Group A will receive patient-specific 3D-printed PEEK membranes designed using cone beam computed tomography (CBCT) data and computer-aided design/computer-aided manufacturing (CAD/CAM) technology. Group B will receive PTFE membranes stabilized over the grafted site using bone tacks.
In both groups, autogenous bone graft combined with xenogeneic bone substitute will be used for ridge augmentation. Standard surgical protocols will be followed, including flap elevation, recipient site preparation, graft placement, and tension-free primary closure.
Clinical outcomes will be assessed by evaluating soft tissue healing, infection, membrane exposure, and wound dehiscence. Radiographic outcomes will be evaluated using CBCT scans taken immediately postoperatively, at 6 months, and at 12 months. Three-dimensional analysis will be performed using specialized software to measure volumetric bone gain as well as linear horizontal and vertical ridge augmentation.
The study aims to determine whether customized PEEK membranes provide comparable or superior outcomes to PTFE membranes in terms of bone regeneration, stability of augmented volume, and postoperative complications.
- Conditions
- Alveolar Ridge Deficiency
- Being tested
- Custom-made PEEK Membrane, PTFE Membrane
- Keywords
- Guided Bone Regeneration, PEEK membrane, PTFE membrane, Ridge augmentation, Maxillary ridge augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-made PEEK MembraneDevice
Customized perforated polyether ether ketone (PEEK) membrane designed from preoperative CBCT data and used for guided bone regeneration during maxillary alveolar ridge augmentation.
PTFE MembraneDevice
Polytetrafluoroethylene (PTFE) membrane used for guided bone regeneration during maxillary alveolar ridge augmentation.
| Study group | Role | What they receive |
|---|---|---|
| PEEK Membrane Group | Experimental | Participants undergo maxillary alveolar ridge augmentation using a customized perforated polyether ether ketone (PEEK) membrane in combination with particulate bone graft material prior to implant placement. Receives: Device: Custom-made PEEK Membrane |
| PTFE Membrane Group | Experimental | Participants undergo maxillary alveolar ridge augmentation using a polytetrafluoroethylene (PTFE) membrane in combination with particulate bone graft material prior to implant placement. Receives: Device: PTFE Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric Bone Gain
Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans.
Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge DeficiencyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into two separate groups: Group A: PEEK membrane Group B: PTFE membrane Each participant receives only one intervention throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dania raad, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679451
- Sponsor's protocol ID
- MS.26.01.108
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom-Made Polyether Ether Ketone Membrane Versus Polytetrafluoroethylene Membrane in Maxillary Alveolar Ridge Augmentation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07679451
- Acronym / sponsor ID
- MS.26.01.108
- Conditions
- Alveolar Ridge Deficiency
- Keywords
- Guided Bone Regeneration, PEEK membrane, PTFE membrane, Ridge augmentation, Maxillary ridge augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 1 Jul 2026 (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 study aims to evaluate and compare the effectiveness of custom-made polyether ether ketone (PEEK) membranes versus polytetrafluoroethylene (PTFE) membranes in guided bone regeneration for maxillary alveolar ridge augmentation in the esthetic zone. Thirty patients requiring ridge augmentation prior to dental implant placement will be enrolled and randomly allocated into two equal groups. Group A will receive customized PEEK membranes, while Group B will be treated with PTFE membranes. Clinical and radiographic assessments, including cone beam computed tomography (CBCT), will be performed immediately postoperatively, at 6 months, and at 12 months to evaluate volumetric, horizontal, and vertical bone gain as well as soft tissue healing and complication rates.
Detailed description
Guided bone regeneration (GBR) is a widely accepted technique used to reconstruct deficient alveolar ridges prior to or in conjunction with dental implant placement. This study is designed to evaluate the clinical and radiographic outcomes of two different non-resorbable barrier membranes in maxillary ridge augmentation: customized polyether ether ketone (PEEK) membranes and polytetrafluoroethylene (PTFE) membranes.
Thirty patients requiring maxillary alveolar ridge augmentation in the esthetic zone will be recruited from the Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University. Patients will be randomly allocated into two groups of equal size. Group A will receive patient-specific 3D-printed PEEK membranes designed using cone beam computed tomography (CBCT) data and computer-aided design/computer-aided manufacturing (CAD/CAM) technology. Group B will receive PTFE membranes stabilized over the grafted site using bone tacks.
In both groups, autogenous bone graft combined with xenogeneic bone substitute will be used for ridge augmentation. Standard surgical protocols will be followed, including flap elevation, recipient site preparation, graft placement, and tension-free primary closure.
Clinical outcomes will be assessed by evaluating soft tissue healing, infection, membrane exposure, and wound dehiscence. Radiographic outcomes will be evaluated using CBCT scans taken immediately postoperatively, at 6 months, and at 12 months. Three-dimensional analysis will be performed using specialized software to measure volumetric bone gain as well as linear horizontal and vertical ridge augmentation.
The study aims to determine whether customized PEEK membranes provide comparable or superior outcomes to PTFE membranes in terms of bone regeneration, stability of augmented volume, and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized into two separate groups: Group A: PEEK membrane Group B: PTFE membrane Each participant receives only one intervention throughout the study.
| Arm | Type | Receives |
|---|---|---|
| PEEK Membrane Group | Experimental | Device: Custom-made PEEK MembraneParticipants undergo maxillary alveolar ridge augmentation using a customized perforated polyether ether ketone (PEEK) membrane in combination with particulate bone graft material prior to implant placement. |
| PTFE Membrane Group | Experimental | Device: PTFE MembraneParticipants undergo maxillary alveolar ridge augmentation using a polytetrafluoroethylene (PTFE) membrane in combination with particulate bone graft material prior to implant placement. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 20 and 45 years. Male or female participants. Presence of single or multiple missing teeth associated with vertical alveolar defects (vertical bone height less than 8 mm), horizontal alveolar defects (ridge width less than 6 mm), or combined defects in the maxillary esthetic zone requiring alveolar ridge augmentation before implant placement.
- Good oral hygiene.
Key exclusion criteria (1 listed)
- Uncontrolled medical disorders contraindicating surgical intervention. Systemic diseases or medications affecting bone metabolism. Current or previous bisphosphonate therapy. History of radiotherapy. History of chemotherapy. Smokers.
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 |
|---|---|---|
| Custom-made PEEK MembraneCustomized perforated polyether ether ketone (PEEK) membrane designed from preoperative CBCT data and used for guided bone regeneration during maxillary alveolar ridge augmentation. | Device | PEEK Membrane Group |
| PTFE MembranePolytetrafluoroethylene (PTFE) membrane used for guided bone regeneration during maxillary alveolar ridge augmentation. | Device | PTFE Membrane Group |
Primary outcome
Volumetric Bone Gain
Time frame: 6 months after surgery
Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans. Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. Up on request from the corresponding author
Related trials for Alveolar Ridge Deficiency
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Not yet recruiting
Effectiveness of Subepithelial Connective Tissue Graft as an Autogenous Barrier Membrane for Hard and Soft Tissue Augmentation in Horizontally Deficient Ridges During Delayed Implant Placement
Horizontally Deficient Alveolar Ridges, Hard and Soft Tissue Augmentation During Delayed Implant Placement
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-made PEEK Membrane and PTFE Membrane in people with Alveolar Ridge Deficiency, run by Mansoura 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 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: looking for participants now, as of the sponsor's last update on 1 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dania Raad, BDS (00201063498933, raaddania7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric Bone Gain (time frame: 6 months 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 1 Jul 2026.