About this trial
This study will compare two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
English speaking
At least 18 years old
Must be a patient of the UAB Dental School
Able to read and understand informed consent document
Disqualifiers
Non-English speaking
Less than 18 years old
Smokers/tobacco users (>10 cigarettes/day)
Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
Trial design
Parallel
Treatments tested in this trial
Allograft particles hydrated with rhPDGF
Biological/VaccineAllograft particles should be hydrated with GEM21S for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.
Allograft particles hydrated in a conventional way with saline.
Biological/VaccineAllograft particles should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane
Treatment groups
Trial outcomes
Primary outcomes
Quantitative histomorphometric evaluation of new bone formation 4 months after GBR
To quantify the distribution of the different tissues (new bone, soft tissue, residual graft and artifact) after 4 months of healing. Hence, the primary outcome will be the new bone formation, defined as the percentage of new bone area in the histomorphometric sections.
Secondary outcomes
Quantitative two- and three-dimensional radiographic comparison of dimensional changes 4 months using cone beam computed tomography (CBCT) and a virtual implant planning software, coDiagnostiX™
quantification of bone width gain after ridge augmentation. both clinically using a caliper to measure the ridge width before and after ridge augmentation and also radiographically using a software that superimpose before and after CBCT to calculate the difference which basically leads to amount of bone gain.
Sponsors and contacts
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