Evaluating bone healing in sinus augmentation using different graft materials
Sinus Augmentation Healing With Autogenous and Xenograft Mix Compared to Xenograft Alone
NA · Tufts University · NCT06247098
This study is testing whether using a mix of your own bone and a different type of bone graft helps people heal better after a sinus lift surgery compared to using just the graft alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tufts University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06247098 on ClinicalTrials.gov |
What this trial studies
This study aims to assess bone healing four months after lateral sinus augmentation using a combination of autologous bone and xenograft compared to xenograft alone. The evaluation will include radiographic volumetric measurements, histomorphometric analysis, and histologic examination to determine the effectiveness of the different grafting techniques. Patients will undergo sinus lift augmentation procedures, and their outcomes will be monitored using cone-beam computed tomography systems. The study is conducted at Tufts University School of Dental Medicine.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 100 with less than 5mm of residual bone height in need of sinus augmentation for dental implants.
Not a fit: Patients with conditions affecting bone metabolism, such as osteoporosis, or those with a history of chemotherapy or head and neck radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the outcomes of sinus augmentation procedures, leading to better dental implant success rates for patients.
How similar studies have performed: Previous studies have shown varying success with different grafting techniques in sinus augmentation, but this specific comparison of autograft and xenograft has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of Tufts School of Dental Medicine (TUSDM) * Two stage sinus augmentations with \<5mm (Zinner, Small 2004) residual bone height in need of augmentation for implant placement * Full maxillary edentulism or Kennedy class I or III * 18 to 100 year old Exclusion Criteria: * Adults unable to consent (cognitively impaired adults) * Those who self-report as pregnant or breastfeeding * Wards of the state * Non-Viable neonates * Neonates of uncertain viability * \< 18 years of age * Refusal to participate * Prior medical condition causing complications in bone metabolism * Osteoporosis * History of/or current chemotherapy * History of/or current head and neck radiation * Current heavy smoking \> 10 cigarettes/day * Self-reported pregnancy or lactation * Previous history of sinus elevation procedure * Existing sinus pathology or pathology discovered at time of sinus augmentation or implant placement * Absence of autogenous donor site
Where this trial is running
Boston, Massachusetts
- Tufts University School of Dental Medicine — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Lorenzo Mordini, DDS, MS — Tufts Univeristy
- Study coordinator: Lorenzo Mordini, DDS, MS
- Email: lorenzo.mordini@tufts.edu
- Phone: 6176366888
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: Maxillary Sinus Floor Augmentation, Dental Implant, Bone Substitute, Autogenous Bone Graft, Histology, Volume measurements, Radiographic