NCT04954664

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Aug 2021Dec 2027

First Submitted

Initial submission to the registry

June 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 11, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

5.3 years

First QC Date

June 29, 2021

Last Update Submit

December 19, 2025

Conditions

Dental ImplantBone Loss

Keywords

New boneDental implants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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™

    From baseline to 4 months

Study Arms (2)

Allograft particles hydrated with rhPDGF

EXPERIMENTAL

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 hydrated in a conventional way with saline.

ACTIVE COMPARATOR

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.

Interventions

Allograft particles hydrated with rhPDGFBIOLOGICAL

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 with rhPDGF
Allograft particles hydrated in a conventional way with saline.BIOLOGICAL

Allograft particles should be hydrated with saline 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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Hussein Basma, DDS, MS

CONTACT

205-934-2888basma86@uab.edu

Sarah Startley, DMD

CONTACT

205-975-8711ss1971@uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The calibrated, trained, masked-examiner (who is unaware of which Group the patient is randomized), will be masked and available during the entire duration of the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 8, 2021

Study Start

August 11, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)