Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh

Assessment of Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh: A Randomized Controlled Clinical Trial

Zirconia can be considered as an alternative and innovative material suitable for GBR because it has high biocompatibility, together with a scarce tissue integration. Zirconia barriers could be a predictable and alternative barrier material for GBR in terms of (i) biocompatibility, (ii) ease of use and removal, (iii) exposure management, (iv) bone regeneration outcomes.

Study Overview

• Status: Recruiting
• Conditions: Mandibular Atrophy
• Intervention / Treatment: Other: customized Zirconia barrier; Other: prebent titanium mesh

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moataz Nasr; Phone Number: 01000353417; Email: Mo3taznasr@gmail.com

Study Locations

• Egypt
  • Kafr Elsheikh, Egypt
    • Recruiting
    • Kafr El-sheikh University
    • Contact: Moataz Nasar, BDS; Phone Number: 002 01000353417; Email: mo3taznasr@gmail.com
    • Principal Investigator: Moataz Nasr, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients are systemically medically free according to the American Society of Anesthesiologists (ASA) considered as ASA I.
• Ability to maintain good oral hygiene as evidenced in recall visits.
• patients who had a partial or completely edentulous alveolar ridge with apparent 3D defect following teeth loss.
• All patients were free from any local or general disease that may interfere with bone healing and had no history of previous grafting procedure at the designated edentulous ridge.
• The ridge had to exhibit severe vertical and horizontal (3D) alveolar ridge deficiency with alveolar ridge height less than 7 mm from the alveolar crest to the inferior alveolar canal and width less than 5 mm which was firstly measured by CBCT, or a clinically apparent increase in inter-arch space relative to the adjacent natural teeth.
• Pre-operative clinical assessment of soft tissue coverage was done to cover the graft and its membrane, in addition to assessment of occlusion and inter-arch distance should allow for the graft, membrane, implan and the future prosthesis.

Exclusion Criteria:

• Smoker (> 25 cigarettes/ day).
• Patients undergoing radiotherapy or chemotherapy
• Patients having infection or local lesions in the area of surgery.
• Patients with diabetes mellitus or bone diseases which may compromise the results.
• Patient with poor oral hygiene or active periodontal disease.
• Patient with limited mouth opening.
• Participation in other clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zirconia	Other: customized Zirconia barrier; It includes eight patients seeking for placement of customized Zirconia barrier after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.
Experimental: Titanium	Other: prebent titanium mesh; It includes eight patients seeking for placement prebent titanium mesh as barriers after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in vertical height of ridge	Cone Beam Computed Tomography (CBCT) was done immediately (1 week) and after six months to evaluate the changes in vertical, horizontal and volumetric measurements of the ridge. OnDemand3D™ software was used to evaluate vertical and horizontal height. Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.	up to 6 months
change in horizontal width of ridge	Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used. Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.	up to 6 months
change in volume of ridge	Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used. Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptoms of infection	Any symptoms of infection including swelling, redness, hotness, pus discharge, and pain will be recorded	up to one month
manifestations of wound healing disturbance	observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure will be recorded	up to one month

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KFSIRB200-205

Drug and device information, study documents

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