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

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).

Study Overview

• Status: Recruiting
• Conditions: Bone Loss; Dental Implant
• Intervention / Treatment: Biological: Allograft particles hydrated with rhPDGF; Biological: Allograft particles hydrated in a conventional way with saline.

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hussein Basma, DDS, MS; Phone Number: 205-934-2888; Email: basma86@uab.edu
• Study Contact Backup: Name: Sarah Startley, DMD; Phone Number: 205-975-8711; Email: ss1971@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • Recruiting
      • Unversity of Alabama at Birmingham, School of Dentistry
      • Contact: Sarah Startley, DMD; Phone Number: 205-975-8711; Email: ss1971@uab.edu
      • Contact: Hussein Basma, DDS, MS; Phone Number: 205-975-2888; Email: basma86@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative histomorphometric evaluation of new bone formation 4 months after GBR	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.	From baseline to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative two- and three-dimensional radiographic comparison of dimensional changes 4 months using cone beam computed tomography (CBCT) and a virtual implant planning software, coDiagnostiX™	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.	From baseline to 4 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Dental implants; New bone
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Bone Diseases, Metabolic; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: IRB-300007719; UAB Periodontology (Other Identifier: University of Alabama at Birmingham)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No