Autogenous Bone Graft, Bone Substitute, Dental Implant, Maxillary Sinus Floor Augmentation
Conditions
Keywords
Histology, Volume measurements, Radiographic
Brief summary
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.
Interventions
PROCEDURESinus Lift augmentation
Randomised Sinus Lift augmentation either with Xenograft - Autogenous ratio 1:4 (test) or Xenograft alone (Control)
DEVICECone-beam computed tomography systems (CBCT)
An research only use of CBCT at visit 2 to review healing status.
Sponsors
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical examiners, study surgeons, and subjects will not be blinded. Analysis of histomorphometric, histologic, and volumetric data will be completed by an external lab and will not be aware of what group the subjects were in.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histological analysis | 4 months from surgery | Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric bone analysis 4 months post sinus augmentation | 4 months from surgery | Sinus volume calculation via CBCT analysis |
| Radiographic bone height gain at 4 months | 4 months post sinus augmentation | Residual alveolar crest Final alveolar crest height at 4 months Initial height of graft immediately post graft placement Vertical bone material resorption |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLorenzo Mordini, DDS, MS
Tufts Univeristy
Outcome results
None listed