Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, 35294-0007, United States
Location status: Recruiting
Location contact
Hussein Basma, DDS, MS
CONTACT
Sarah Startley, DMD
CONTACT
NCT Number: NCT04954664
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).
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35294-0007, United States
Location status: Recruiting
Hussein Basma, DDS, MS
CONTACT
Sarah Startley, DMD
CONTACT
This is a prospective, randomized, and examiner-only-masked study. It is designed to clinically compare the use of bone particulate allograft hydrated with rhPDGF vs bone particulate allograft hydrated with saline, for patients who were planned to receive dental implants but presented with deficient bone ridges. This investigation of 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).
In two arms, bone core biopsies will be harvested at time of implant placement 4 months following ridge augmentation grafting. These 2x8mm bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between in both study arms.
Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.
Cone beam computed tomography (CBCT) initial scans are conducted immediately following prior to ridge augmentation and second scans obtained prior to implant placement both arms. These types of Cone Beam CT scans as well as conventional dental x-rays are valuable treatment planning tools that are commonly used in modern-day implant dentistry. The scans and the x-ray images are also used to monitor the health of tissues surrounding implants and to make sure that the implant remains securely implanted into the jawbone over time.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Allograft 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 should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane
Time frame: From baseline to 4 months
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.
Time frame: From baseline to 4 months
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.
Contact information is provided by the study sponsor or research team.
Hussein Basma, DDS, MS
CONTACT
Sarah Startley, DMD
CONTACT
University of Alabama at Birmingham
Other
Lateral Ridge Augmentation Using Allograft Bone Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor: A Clinical and Histological Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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