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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04954664
Status
Recruiting
Apply to this trial

Conditions

  • Bone Loss
  • Dental Implant

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Allograft particles hydrated with rhPDGF — BIOLOGICAL
    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. — 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

Study Details

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).

Key Dates

Start date
Aug 11, 2021
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Unversity of Alabama at Birmingham, School of DentistryBirminghamAlabama35294-0007
Hussein Basma, DDS, MS
[email protected]
205-975-2888
Sarah Startley, DMD
[email protected]
205-975-8711

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By research site
Unversity of Alabama at Birmingham, School of Dentistry· Birmingham, AL

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