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

NCT06227455 | Completed

• 1 other identifier: A02030123
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical examination

  Sixth postoperative months

Study Arms (2)

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.

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.

Procedure: Maxillary alveolar ridge augmentation

Interventions

Maxillary alveolar ridge augmentation PROCEDURE

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; Ti PTFE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Delta University for Science and Technology: lead
• Mansoura University: collaborator

Study Sites (1)

Mansoura University

Al Mansurah, Addakahlyia, 35516, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40682045 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Alveolar Ridge Augmentation

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 26, 2024
• Study Start: February 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

EG (1)