NCT04954664

Ridge Augmentation Using Allograft Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor

Lateral Ridge Augmentation Using Allograft Bone Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor: A Clinical and Histological Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Dental Implant
• Bone Loss

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	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

Timeline

• Start date: 2021-08-11
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2021-07-08
• Last updated: 2025-12-29

Locations

1 site across 1 country: United States