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Bone Graft

Bone Graft with rhPDGF vs. Saline for Dental Implants

N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth
Be older than 18 years old
Must not have
Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
Non-English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 4 months
Awards & highlights

Summary

This trial will compare two methods of increasing the size of the jawbone, using a resorbable barrier membrane and either a bone graft with saline or a growth factor called rhPDGF.

Who is the study for?
This trial is for adults over 18 who are patients at the UAB Dental School, need dental implants due to insufficient alveolar ridge width, and can understand the consent form. It's not for smokers, those with conditions that affect healing or oral surgery risks, non-English speakers, minors, or individuals with poor compliance risk.
What is being tested?
The study compares two methods of increasing bone ridge dimensions before dental implant placement: one using a graft hydrated with saline and another using Recombinant Human Platelet-Derived Growth Factor (rhPDGF).
What are the potential side effects?
Potential side effects may include discomfort at the graft site, swelling, infection risk increase around the treated area and possible allergic reactions to rhPDGF.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need dental implants for missing teeth in one part of my mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any health conditions that would interfere with surgery or healing.
Select...
I do not speak English.
Select...
I have bone loss where I am missing teeth.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quantitative histomorphometric evaluation of new bone formation 4 months after GBR
Secondary study objectives
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™

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Allograft particles hydrated with rhPDGFExperimental Treatment1 Intervention
Allograft particles should be hydrated with GEM21S for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.
Group II: Allograft particles hydrated in a conventional way with saline.Active Control1 Intervention
Allograft particles should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,934 Total Patients Enrolled
18 Trials studying Osteoporosis
583,688 Patients Enrolled for Osteoporosis

Media Library

Allograft particles hydrated with saline (Bone Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04954664 — N/A
Osteoporosis Research Study Groups: Allograft particles hydrated with rhPDGF, Allograft particles hydrated in a conventional way with saline.
Osteoporosis Clinical Trial 2023: Allograft particles hydrated with saline Highlights & Side Effects. Trial Name: NCT04954664 — N/A
Allograft particles hydrated with saline (Bone Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04954664 — N/A
Osteoporosis Patient Testimony for trial: Trial Name: NCT04954664 — N/A
~2 spots leftby Dec 2024
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