Mandibular Atrophy
Conditions
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.
Interventions
OTHERcustomized 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.
OTHERprebent 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.
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in vertical height of ridge | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| symptoms of infection | up to one month | Any symptoms of infection including swelling, redness, hotness, pus discharge, and pain will be recorded |
| manifestations of wound healing disturbance | up to one month | observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure will be recorded |
Countries
Egypt
Contacts
CONTACTMoataz Nasr
Outcome results
None listed