Recruiting

Allograft with PDGF

Sponsor:

University of Alabama at Birmingham

Code:

NCT04954664

Conditions

Dental Implant

Bone Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Allograft particles hydrated with rhPDGF

Allograft particles hydrated in a conventional way with saline.

Study Details

Brief 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).

Conditions

Dental Implant

Bone Loss

Study ID

NCT04954664

Start date

Aug 11, 2021

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

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

Primary outcome measure

  • Quantitative histomorphometric evaluation of new bone formation 4 months after GBR [ Time Frame: From baseline to 4 months ]

Central Contacts and Locations

Central contacts

Hussein Basma, DDS, MS

205-934-2888basma86@uab.edu

Sarah Startley, DMD

205-975-8711ss1971@uab.edu

Locations

Unversity of Alabama at Birmingham, School of Dentistry

Recruiting

Birmingham, Alabama, United States, 35294-0007

Contacts

Hussein Basma, DDS, MS

205-975-2888basma86@uab.edu

Sarah Startley, DMD

205-975-8711ss1971@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • New bone
  • Dental implants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-29.