ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis.

Official Title

Sinus Augmentation Healing With Autogenous and Xenograft Mix Compared to Xenograft Alone

Quick Facts

Study Start:2024-09-01
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06247098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients of Tufts School of Dental Medicine (TUSDM)
  2. * Two stage sinus augmentations with \<5mm (Zinner, Small 2004) residual bone height in need of augmentation for implant placement
  3. * Full maxillary edentulism or Kennedy class I or III
  4. * 18 to 100 year old
  1. * Adults unable to consent (cognitively impaired adults)
  2. * Those who self-report as pregnant or breastfeeding
  3. * Wards of the state
  4. * Non-Viable neonates
  5. * Neonates of uncertain viability
  6. * \< 18 years of age
  7. * Refusal to participate
  8. * Prior medical condition causing complications in bone metabolism
  9. * Osteoporosis
  10. * History of/or current chemotherapy
  11. * History of/or current head and neck radiation
  12. * Current heavy smoking \> 10 cigarettes/day
  13. * Self-reported pregnancy or lactation
  14. * Previous history of sinus elevation procedure
  15. * Existing sinus pathology or pathology discovered at time of sinus augmentation or implant placement
  16. * Absence of autogenous donor site

Contacts and Locations

Principal Investigator

Lorenzo Mordini, DDS, MS
PRINCIPAL_INVESTIGATOR
Tufts Univeristy

Study Locations (Sites)

Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
United States

Collaborators and Investigators

Sponsor: Tufts University

  • Lorenzo Mordini, DDS, MS, PRINCIPAL_INVESTIGATOR, Tufts Univeristy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01
Study Completion Date2028-05

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

  • Histology
  • Volume measurements
  • Radiographic

Additional Relevant MeSH Terms

  • Maxillary Sinus Floor Augmentation
  • Dental Implant
  • Bone Substitute
  • Autogenous Bone Graft