Comparing two types of bone graft materials for jaw surgery
Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation: A Double Arm Randomized Control And Histomorphometric Study
This study is testing whether using fiber or particle forms of a bone graft can help people getting jaw surgery grow more healthy bone for their dental implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06173791 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of demineralized freeze-dried bone allograft (DFDBA) fibers compared to DFDBA particles when used in conjunction with demineralized bovine bone mineral (DBBM) for sinus augmentation procedures. Patients requiring maxillary sinus augmentation to support dental implants will be randomly assigned to receive either DFDBA fibers or DFDBA particles. The study will assess the amount of vital bone formation histologically and the radiographic volume achieved six months post-procedure. Both treatment options are considered standard care, and bone samples will be collected as a by-product of the implant placement.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 89 who require sinus augmentation for dental implants and meet specific smoking and health criteria.
Not a fit: Patients who smoke more than 10 cigarettes per day or are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved bone formation outcomes for patients undergoing sinus augmentation.
How similar studies have performed: Previous studies have shown varying success with different bone graft materials, but this specific comparison of DFDBA fibers versus particles is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between age 18 and 89 * Patients needing sinus augmentation to support implant placement in the posterior maxilla * Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report * Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential. Exclusion Criteria: * Patients who disclose that they will not be able to cooperate with the follow-up schedule. * Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) * Pregnant women or women intending to become pregnant during study period * Smokers who smoke \> 10 cigarettes per day
Where this trial is running
San Antonio, Texas
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Angela Palaiologou-Gallis, DDS, MS — The University of Texas Health Science Center at San Antonio
- Study coordinator: Angela Palaiologou-Gallis, DDS, MS
- Email: PalaiologouA@uthscsa.edu
- Phone: 210-567-3567
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.