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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

No Placebo-Only Group

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:

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I do not have any health conditions that would interfere with surgery or healing.

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I do not speak English.

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I have bone loss where I am missing teeth.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 4 months

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™

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met