Effect of teriparatide on bone growth in the maxillary sinus for dental implants
Bone Microarchitecture and Implant Stabilization in Atrophic Jaws Reconstructed With Bone Grafts Treated With Teriparatide
This study is testing if adding teriparatide to a bone graft can help people with not enough bone in their upper jaw grow more bone for dental implants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 25 Years to 70 Years |
| Sex | All |
| Sponsor | Universidad de Valparaiso Academic / other |
| Locations | 1 site (Valparaíso, Valparaiso) |
| Trial ID | NCT06061354 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of teriparatide combined with a xenograft on bone augmentation in the maxillary sinus, specifically for patients with insufficient bone height for dental implants. It involves a triple-blind randomized controlled design with 42 participants who will receive either Bio-Oss® alone or Bio-Oss® with teriparatide. Bone biopsies will be taken three months post-grafting to analyze the microarchitecture of the newly formed bone and assess the stability of the dental implants. The study aims to provide insights into the effectiveness of teriparatide in enhancing bone regeneration in this specific dental procedure.
Who should consider this trial
Good fit: Ideal candidates are individuals with a maxillary sinus that has a residual ridge height of 5 mm or less, requiring augmentation for dental implants.
Not a fit: Patients with residual ridges less than 4 mm, uncontrolled systemic diseases, or conditions affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve bone regeneration techniques, leading to better outcomes for patients requiring dental implants.
How similar studies have performed: Other studies have shown promising results with teriparatide in bone regeneration, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pneumatization of a maxillary sinus with a residual ridge ≤ 5 mm in height (according to baseline conebeam tomograph). * Must sign an informed consent to participate in this study. Exclusion Criteria: * Residual ridges less than 4 mm in height. * Uncontrolled systemic disease (ASA 3, 4, 5, and 6) * Presenting with osteoporosis or any disease of bone metabolism. * Having received radiotherapy. * Cancer. * Any systemic condition that affects calcium absorption. * Kidney disease. * Coagulation disorders. * History of sinusitis. * Maxillary sinus pathology. * Heavy smoking (\> 1 pack per day). * Drug or alcohol users. * Pregnancy. * Treatment with drugs that affect bone metabolism. * Treatment with immunosuppressants. * Allergies. * Uncontrolled periodontal pathology. * Tooth extractions in the last three months.
Where this trial is running
Valparaíso, Valparaiso
- Facultad de Odontología, Universidad de Valparaiso — Valparaíso, Valparaiso, Chile (Recruiting)
Study contacts
- Study coordinator: Jessika Dethlefs, DDS, MSc
- Email: jessika.dethlefs@uv.cl
- Phone: +56993231103
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.