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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Alabama at Birmingham

About this 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English speaking

At least 18 years old

Must be a patient of the UAB Dental School

Able to read and understand informed consent document

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Allograft particles hydrated with rhPDGF

    Biological/Vaccine

    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/Vaccine

    Allograft particles should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Allograft particles hydrated with rhPDGFExperimental treatment 1 intervention
Group B: Allograft particles hydrated in a conventional way with saline.Active comparator 1 intervention

Trial outcomes

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.

Time frame
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™

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.

Time frame
From baseline to 4 months

Other outcomes

Sponsors and contacts

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