Efficacy of Customized Zirconia Sheet vs PTFE as a Non-resorbable Barrier in Maxillary Alveolar Ridge Augmentation
NCT ID: NCT06227455
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2023-02-01
2024-11-01
Brief Summary
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1. Is custom made zirconia sheets are valuable as a non-resorbable membrane in guided bone regeneration?
2. Does it have any adverse effects on the surrounding tissue?
3. 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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ti PTFE
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.
Maxillary alveolar ridge augmentation
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.
Customized zirconia Barrier
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.
Maxillary alveolar ridge augmentation
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.
Interventions
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Maxillary alveolar ridge augmentation
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Delta University for Science and Technology
OTHER
Responsible Party
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Locations
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Mansoura University
Al Mansurah, Addakahlyia, Egypt
Countries
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References
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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.
Other Identifiers
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A02030123
Identifier Type: -
Identifier Source: org_study_id