Clinical trial
Lateral Ridge Augmentation Using Allograft Bone Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor: A Clinical and Histological Randomized Controlled Trial
Name
IRB-300007719
Description
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).
Trial arms
Trial start
2021-08-11
Estimated PCD
2024-09-01
Trial end
2025-09-01
Status
Recruiting
Treatment
Allograft particles hydrated with rhPDGF
Allograft particles should be hydrated with GEM21S for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.
Arms:
Allograft particles hydrated with rhPDGF
Allograft particles hydrated in a conventional way with saline.
Allograft particles should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane
Arms:
Allograft particles hydrated in a conventional way with saline.
Size
44
Primary endpoint
Quantitative histomorphometric evaluation of new bone formation 4 months after GBR
From baseline to 4 months
Eligibility criteria
Inclusion Criteria:
* English speaking
* At least 18 years old
* Must be a patient of the UAB Dental School
* Able to read and understand informed consent document
* Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth.
* Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan.
Exclusion Criteria:
* 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
* Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
* Vertical loss of bone at edentulous ridge.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The calibrated, trained, masked-examiner (who is unaware of which Group the patient is randomized), will be masked and available during the entire duration of the study.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}
Updated at
2023-08-07
1 organization
2 products
2 indications
Organization
University of Alabama at BirminghamIndication
Dental ImplantIndication
OsteoporosisProduct
Allograft particles