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

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• change in vertical height of ridge [Time frame: up to 6 months]
• change in horizontal width of ridge [Time frame: up to 6 months]
• change in volume of ridge [Time frame: up to 6 months]

Secondary outcome measures (2)

• symptoms of infection [Time frame: up to one month]
• manifestations of wound healing disturbance [Time frame: up to one month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Kafr El-sheikh University — Kafr Elsheikh

Identifiers

NCT: NCT07700095 · KFSIRB200-205

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗