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Search / Trial NCT06247098

Evaluation of Sinus Augmentation Bone Healing Using Autograft and Xenograft Compared to Xenograft Alone

Launched by TUFTS UNIVERSITY · Jan 30, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Histology Volume Measurements Radiographic

ClinConnect Summary

This clinical trial is studying how well different types of bone grafts help heal the bone in the upper jaw (maxillary sinus) after a procedure called sinus augmentation, which is often needed before placing dental implants. Researchers want to compare the healing process when using a mix of a patient’s own bone (called autograft) combined with a cow-derived bone substitute (xenograft) versus using just the cow-derived substitute alone. The goal is to see which method leads to better bone healing after four months.

To participate, individuals must be between 18 and 100 years old and have certain dental conditions, such as having very little bone left in the upper jaw that needs to be built up for implant placement. Some people, like those with specific health issues or those who are pregnant or breastfeeding, will not be eligible to join. Participants in this trial can expect to receive care from the dental team at Tufts School of Dental Medicine and will undergo imaging and analysis to monitor how well their bone heals after the procedure. This research could help improve future treatments for patients needing dental implants.

Gender

ALL

Eligibility 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

About Tufts University

Tufts University is a prestigious research institution renowned for its commitment to advancing health and medicine through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Tufts leverages its expertise in biomedical research, public health, and clinical practice to design and conduct rigorous studies that address critical health challenges. The university's clinical trial programs are characterized by their adherence to high ethical standards and regulatory compliance, ensuring the safety and well-being of participants while contributing valuable insights to the scientific community. Through its dedication to fostering education and research, Tufts University plays a vital role in translating findings into effective health interventions and policies.

Locations

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Patients applied

AG

SS

2 patients applied

Trial Officials

Lorenzo Mordini, DDS, MS

Principal Investigator

Tufts Univeristy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported