About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
customized Zirconia barrier
Other interventionIt 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.
prebent titanium mesh
Other interventionIt 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
symptoms of infection
Any symptoms of infection including swelling, redness, hotness, pus discharge, and pain will be recorded
manifestations of wound healing disturbance
observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure will be recorded
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and contacts
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Hams Hamed Abdelrahman
Lead sponsor
Alexandria University
Sponsor institution