Comparing two methods for bone ridge augmentation before dental implants
Lateral Ridge Augmentation Using Allograft Bone Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor: A Clinical and Histological Randomized Controlled Trial
NA · University of Alabama at Birmingham · NCT04954664
This study is testing two different ways to help patients get enough bone for dental implants to see which method works better for healing.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04954664 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two techniques for increasing ridge dimensions in patients preparing for dental implants. One technique uses bone particulate allograft hydrated with recombinant human platelet-derived growth factor (rhPDGF), while the other uses the same allograft hydrated with saline. The study is prospective, randomized, and examiner-only-masked, involving bone core biopsies and clinical measurements at two time points to assess healing differences. Cone beam computed tomography scans will also be utilized to monitor bone health before and after the augmentation.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults over 18 with insufficient alveolar ridge width for dental implants.
Not a fit: Patients who are non-English speaking, under 18, smokers, or have systemic conditions affecting healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the success rate of dental implants by improving bone ridge dimensions.
How similar studies have performed: Previous studies have shown promising results with similar approaches using growth factors in bone augmentation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Birmingham, Alabama
- Unversity of Alabama at Birmingham, School of Dentistry — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Study coordinator: Hussein Basma, DDS, MS
- Email: basma86@uab.edu
- Phone: 205-934-2888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Implant, Bone Loss, New bone, Dental implants