Clinical trial NCT06227455: Efficacy of Customized Zirconia Sheet vs PTFE as a Non-resorbable Barrier in Maxillary Alveolar Ridge Augmentation
Official title: Efficacy of Custom-made Zirconia Sheet Versus Polytetrafluoroethylene as a Non-resorbable Barrier in Maxillary Alveolar Ridge Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
Collaborators: name: Mansoura University
First posted: 2024-01-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Bone volume in cubic millimeters
timeFrame: First postoperative week
measure: Bone volume in cubic millimeters
timeFrame: Sixth postoperative month
Secondary outcomes:
measure: Clinical examination
timeFrame: Sixth postoperative months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Addakahlyia
Study officials:
References: