Efficacy of Customized Zirconia Sheet vs PTFE as a Non-resorbable Barrier in Maxillary Alveolar Ridge Augmentation

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:

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: Maxillary alveolar ridge augmentation

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Addakahlyia
    • Mansoura, Addakahlyia, Egypt, 35516
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone volume in cubic millimeters	Volume of the gained bone is assessed by cone-beam computed tomography (CBCT)	First postoperative week
Bone volume in cubic millimeters	Volume of the gained bone is assessed by cone-beam computed tomography (CBCT)	Sixth postoperative month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical examination	Patients are examined for any cardinal sign of inflammation (Positive/negative)	Sixth postoperative months

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology
• Collaborators: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 24, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: A02030123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No