Alveolar Bone LossNCT06227455
Efficacy of Customized Zirconia Sheet vs PTFE as a Non-resorbable Barrier in Maxillary Alveolar Ridge Augmentation
A study testing Maxillary alveolar ridge augmentation in people with Alveolar Bone Loss, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
The goal of this clinical trial is comparing the efficacy of custom-made zirconia sheet versus Polytetrafluoroethylene as a non-resorbable barrier in maxillary alveolar ridge augmentation. The main question it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Maxillary alveolar ridge augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Nov 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients should be free from any relevant systemic disease that would contraindicate surgical intervention or affect bone healing.
- Patients with single or multiple missing teeth with vertical alveolar defect or severe horizontal defect or both types of defects, preventing placement of any implant or prosthetic appliance in maxilla.
- Clinically apparent increase in interarch space relative to the adjacent alveolar teeth.
Who cannot join
- History of uncontrolled medical disorders.
- History of systemic diseases or medication that alter bone metabolism.
- Poor oral hygiene.
- Heavy smoker (more than ten cigarettes/day) or alcoholic patients.
- Chemotherapy or Radiation therapy to the head and neck region in the 12 months prior to the proposed therapy.
- Patients currently on or with a history of bisphosphonate therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Custom-made Zirconia Sheet Versus Polytetrafluoroethylene as a Non-resorbable Barrier in Maxillary Alveolar Ridge Augmentation
The goal of this clinical trial is comparing the efficacy of custom-made zirconia sheet versus Polytetrafluoroethylene as a non-resorbable barrier in maxillary alveolar ridge augmentation. The main question it aims to answer are:
- Is custom made zirconia sheets are valuable as a non-resorbable membrane in guided bone regeneration?
- Does it have any adverse effects on the surrounding tissue?
- the accuracy of using two software in the designing of the zircon membrane?
Read more
- Participants will be selected according to the inclusion criteria of the study, having a defect in the upper jaw that prevent rehabilitation of the jaw.
- Participant will undergo a surgical procedure for placement of bone graft and the non-resorbable membrane.
Researchers will compare between two groups which differ only in the used membrane. a group where the researchers will place custom made zirconia sheet versus a group where the researchers will place Polytetrafluoroethylene.
Read the detailed description
The study protocol demonstrates a comprehensive approach to alveolar ridge augmentation for implant placement. By utilizing 3D patient individualized zirconia barriers and TI PTFE (Titanium Reinforced Polytetrafluoroethylene) membranes, the researchers aim to compare the efficacy of these techniques in achieving successful bone gain. The preoperative evaluation, including medical history, physical examination, and CBCT, ensures that patients meet the inclusion criteria and allows for accurate planning and design of the barriers. The use of specialized software for barrier design and a computer-aided milling machine for fabrication further enhances the precision and customization of the barriers. Sterilization procedures are meticulously outlined, ensuring the safety and effectiveness of the zirconia barriers.
The surgical procedure involves careful flap reflection, autogenous graft harvesting, and placement and fixation of the barriers over mixture of Autogenous graft and xenograft particles . In Group I, the TI PTFE membrane is shaped and pre-bent on a 3D printed augmented model then fixed over the graft and alveolar defect to adapt to the alveolar defect, providing a protective barrier for the graft. In Group II, the initial try-in of the zirconia barrier allows for adjustments to ensure a proper fit and tension-free primary closure. Finally the zirconia membrane is placed over the harvested bone in the recipient site. Both barriers are fixed with bone screws at well marked computer guided positions ensuring the safety of neighboring teeth and vital structures.
The evaluation process involves cone beam CT and clinical assessment at specific intervals to evaluate bone gain, soft tissue inflammation, infection, and dehiscence. The use of 3D models and software allows for accurate volumetric analysis and measurement of the alveolar ridge dimensions, providing valuable data for evaluation.
In conclusion, this study protocol demonstrates a meticulous and comprehensive approach to alveolar ridge augmentation.
- Conditions
- Alveolar Bone Loss
- Being tested
- Maxillary alveolar ridge augmentation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary alveolar ridge augmentationProcedure or surgery
The surgical procedure involves careful flap reflection, autogenous graft harvesting, and placement and fixation of the barriers over mixture of Autogenous graft and xenograft particles.
| Study group | Role | What they receive |
|---|---|---|
| Ti PTFE | Sham comparator | TI PTFE is pre-bent and adapted over a 3D printed model for the alveolar defect area after virtual augmentation then used intra-operative over the mixture of Autogenous and xenograft particles. Receives: Procedure: Maxillary alveolar ridge augmentation |
| Customized zirconia Barrier | Active comparator | After virtual augmentation of the defect area, a customized 3D zirconia barrier is designed on a specialized software (Autodesk Meshmixer). The exported STL file of the designed barrier is milled and sterilized. Intra-operatively, the initial try-in of the zirconia barrier is done to allow for adjustment and ensuring a proper fit and tension-free primary closure. Receives: Procedure: Maxillary alveolar ridge augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume in cubic millimeters
Volume of the gained bone is assessed by cone-beam computed tomography (CBCT)
Measured: First postoperative week
Bone volume in cubic millimeters
Volume of the gained bone is assessed by cone-beam computed tomography (CBCT)
Measured: Sixth postoperative month
Secondary outcomes (1)
Clinical examination
Patients are examined for any cardinal sign of inflammation (Positive/negative)
Measured: Sixth postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Feb 2023
- Primary completion1 Aug 2024
- Study completion1 Nov 2024
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 Alveolar Bone LossStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227455
- Sponsor's protocol ID
- A02030123
- Status last verified
- Nov 2024
- First submitted
- 18 Jan 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sakr MI, Salem AS, Yaseen AA, Tawfik MA, Mansour NA. Early postoperative evaluation of an open-source digital workflow for designing custom-made zirconia membranes in maxillary guided bone regeneration. BMC Oral Health. 2025 Jul 18;25(1):1200. doi: 10.1186/s12903-025-06592-0.
PubMed 40682045
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Custom-made Zirconia Sheet Versus Polytetrafluoroethylene as a Non-resorbable Barrier in Maxillary Alveolar Ridge Augmentation
- ClinicalTrials.gov ID
- NCT06227455
- Acronym / sponsor ID
- A02030123
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 26 Jan 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.
The goal of this clinical trial is comparing the efficacy of custom-made zirconia sheet versus Polytetrafluoroethylene as a non-resorbable barrier in maxillary alveolar ridge augmentation. The main question it aims to answer are:
- Is custom made zirconia sheets are valuable as a non-resorbable membrane in guided bone regeneration?
- Does it have any adverse effects on the surrounding tissue?
- the accuracy of using two software in the designing of the zircon membrane?
- Participants will be selected according to the inclusion criteria of the study, having a defect in the upper jaw that prevent rehabilitation of the jaw.
- Participant will undergo a surgical procedure for placement of bone graft and the non-resorbable membrane.
Researchers will compare between two groups which differ only in the used membrane. a group where the researchers will place custom made zirconia sheet versus a group where the researchers will place Polytetrafluoroethylene.
Detailed description
The study protocol demonstrates a comprehensive approach to alveolar ridge augmentation for implant placement. By utilizing 3D patient individualized zirconia barriers and TI PTFE (Titanium Reinforced Polytetrafluoroethylene) membranes, the researchers aim to compare the efficacy of these techniques in achieving successful bone gain. The preoperative evaluation, including medical history, physical examination, and CBCT, ensures that patients meet the inclusion criteria and allows for accurate planning and design of the barriers. The use of specialized software for barrier design and a computer-aided milling machine for fabrication further enhances the precision and customization of the barriers. Sterilization procedures are meticulously outlined, ensuring the safety and effectiveness of the zirconia barriers.
The surgical procedure involves careful flap reflection, autogenous graft harvesting, and placement and fixation of the barriers over mixture of Autogenous graft and xenograft particles . In Group I, the TI PTFE membrane is shaped and pre-bent on a 3D printed augmented model then fixed over the graft and alveolar defect to adapt to the alveolar defect, providing a protective barrier for the graft. In Group II, the initial try-in of the zirconia barrier allows for adjustments to ensure a proper fit and tension-free primary closure. Finally the zirconia membrane is placed over the harvested bone in the recipient site. Both barriers are fixed with bone screws at well marked computer guided positions ensuring the safety of neighboring teeth and vital structures.
The evaluation process involves cone beam CT and clinical assessment at specific intervals to evaluate bone gain, soft tissue inflammation, infection, and dehiscence. The use of 3D models and software allows for accurate volumetric analysis and measurement of the alveolar ridge dimensions, providing valuable data for evaluation.
In conclusion, this study protocol demonstrates a meticulous and comprehensive approach to alveolar ridge augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ti PTFE | Sham comparator | Procedure: Maxillary alveolar ridge augmentationTI PTFE is pre-bent and adapted over a 3D printed model for the alveolar defect area after virtual augmentation then used intra-operative over the mixture of Autogenous and xenograft particles. |
| Customized zirconia Barrier | Active comparator | Procedure: Maxillary alveolar ridge augmentationAfter virtual augmentation of the defect area, a customized 3D zirconia barrier is designed on a specialized software (Autodesk Meshmixer). The exported STL file of the designed barrier is milled and sterilized. Intra-operatively, the initial try-in of the zirconia barrier is done to allow for adjustment and ensuring a proper fit and tension-free primary closure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients should be free from any relevant systemic disease that would contraindicate surgical intervention or affect bone healing.
- Patients with single or multiple missing teeth with vertical alveolar defect or severe horizontal defect or both types of defects, preventing placement of any implant or prosthetic appliance in maxilla.
- Clinically apparent increase in interarch space relative to the adjacent alveolar teeth.
Key exclusion criteria (6 listed)
- History of uncontrolled medical disorders.
- History of systemic diseases or medication that alter bone metabolism.
- Poor oral hygiene.
- Heavy smoker (more than ten cigarettes/day) or alcoholic patients.
- Chemotherapy or Radiation therapy to the head and neck region in the 12 months prior to the proposed therapy.
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 alveolar ridge augmentationThe surgical procedure involves careful flap reflection, autogenous graft harvesting, and placement and fixation of the barriers over mixture of Autogenous graft and xenograft particles. | Procedure or surgery | Customized zirconia Barrier, Ti PTFE |
Primary outcome
Bone volume in cubic millimeters
Time frame: First postoperative week
Volume of the gained bone is assessed by cone-beam computed tomography (CBCT)
Bone volume in cubic millimeters
Time frame: Sixth postoperative month
Volume of the gained bone is assessed by cone-beam computed tomography (CBCT)
1 secondary outcome
Clinical examination
Time frame: Sixth postoperative 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 Nov 2024.
- Derived from this study: PubMed 40682045Sakr MI, Salem AS, Yaseen AA, Tawfik MA, Mansour NA. Early postoperative evaluation of an open-source digital workflow for designing custom-made zirconia membranes in maxillary guided bone regeneration. BMC Oral Health. 2025 Jul 18;25(1):1200. doi: 10.1186/s12903-025-06592-0.
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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.
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 Maxillary alveolar ridge augmentation in people with Alveolar Bone Loss, run by Delta University for Science and Technology 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 6 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 Nov 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. Some participants in this study may receive a placebo. 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?
Bone volume in cubic millimeters (time frame: First postoperative week). The study lists 2 primary outcomes in all. 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 NCT06227455, 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 27 Nov 2024.