NCT07700095CompletedNot Applicable

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

Hams Hamed Abdelrahman · Alexandria University2 sites in 1 country16 enrolledStarted: August 3, 2024Last updated: September 29, 2026

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 16
Locations: 2
Primary Endpoint: change in vertical height of ridge

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers

Study Overview

Brief Summary

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 Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel assignment
Primary Purpose: Treatment
Masking: None (open label)

Eligibility Criteria

Ages: 20 Years to 50 Years (Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Arms & Interventions

Zirconia

Experimental

Intervention: customized Zirconia barrier (Other)

Titanium

Experimental

Intervention: prebent titanium mesh (Other)

Outcomes

Primary Outcomes

change in vertical height of ridge

Time Frame: up to 6 months

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.

change in horizontal width of ridge

Time Frame: up to 6 months

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.

change in volume of ridge

Time Frame: up to 6 months

Secondary Outcomes

symptoms of infection(up to one month)
manifestations of wound healing disturbance(up to one month)

Investigators

Sponsor

Hams Hamed AbdelrahmanAlexandria University

Sponsor Class

Other

Responsible Party

Sponsor-investigator

Principal Investigator

Hams Hamed Abdelrahman

Lecturer of Dental Public Health and biostatistical consultanat

Alexandria University

Study Sites (2)

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Identifiers

NCT ID: NCT07700095
Other Study IDs: KFSIRB200-205

Dates

First Submitted: July 7, 2026 (2 months ago)
First Posted: July 13, 2026 (2 months ago)
Primary Completion: September 1, 2026 (29 days ago)
Study Completion: September 1, 2026 (29 days ago)
Last Verified: September 1, 2026 (29 days ago)
Last updated: September 29, 2026 (yesterday)

Regulatory & Sharing

FDA Regulated Drug: No
FDA Regulated Device: No
Has Results: No