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NCT07700095
Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh
Conditions: Mandibular Atrophy
Sex: All
Ages: 20 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: Hams Hamed Abdelrahman
Location: Kafr El-sheikh University Kafr Elsheikh
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.
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
Source: ClinicalTrials.gov (NCT07700095). StuddyBuddy aggregates publicly available trial information.