Comparing bone regeneration techniques for ridge augmentation
Guided Bone Regeneration With and Without Use of Intra-marrow Penetrations: A Prospective Human Clinical and Histologic Study
This study is testing if a new bone regeneration technique that includes penetrating the bone marrow can help patients who need ridge augmentation better than the standard method without this step.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Trial ID | NCT06353399 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of guided bone regeneration techniques with and without intra-marrow penetrations in patients undergoing ridge augmentation. A total of 24 patients will be divided into two groups, with one group receiving the experimental treatment involving intra-marrow penetrations and the other serving as a control group without this intervention. Clinical and histologic outcomes will be assessed six months post-surgery through various measurements, including plaque index and clinical attachment levels. The study will also include a comprehensive presurgical management phase to ensure patient readiness and accurate baseline data collection.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older who require ridge augmentation and can provide informed consent.
Not a fit: Patients with significant systemic diseases, a history of osteonecrosis, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of bone regeneration procedures, leading to improved outcomes for patients requiring ridge augmentation.
How similar studies have performed: While similar approaches have been explored, this specific comparison of intra-marrow penetrations in guided bone regeneration is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy male or female who is at least 18 years old. * Patients must sign an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria: * Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. * Presence or history of osteonecrosis of jaws. * Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration. * Patients who have been treated with oral bisphosphonates for more than three years. * Patients with an allergy to any material or medication used in the study. * Patients who need prophylactic antibiotics * Previous head and neck radiation therapy. * Chemotherapy in the previous 12 months. * Patients on long term NSAID or steroid therapy. * Pregnant patients.
Where this trial is running
Louisville, Kentucky and 1 other locations
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Himabindu Dukka, DMD
- Email: himabindu.dukka@louisville.edu
- Phone: 502-852-1817
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.