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

Last updated: January 7, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Bone Density

Osteopenia

Treatment

Allograft particles hydrated with rhPDGF

Allograft particles hydrated in a conventional way with saline.

Clinical Study ID

NCT04954664
IRB-300007719
UAB Periodontology
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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 themouth.

  • Insufficient alveolar ridge width for endosseous implant placement defined as 5mm orless as determined by bone sounding and cone beam computed tomography (CBCT) scan.

Exclusion

Exclusion Criteria:

  • Non-English speaking

  • Less than 18 years old

  • Smokers/tobacco users (>10 cigarettes/day)

  • Patients with systemic pathologies or conditions contraindicating oral surgicalprocedures or adversely affecting wound healing

  • Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol ordrug abuse)

  • Vertical loss of bone at edentulous ridge.

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Allograft particles hydrated with rhPDGF
Phase:
Study Start date:
August 11, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Unversity of Alabama at Birmingham, School of Dentistry

    Birmingham, Alabama 35294-0007
    United States

    Active - Recruiting

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