Sinus Augmentation Healing With Autogenous and Xenograft Mix Compared to Xenograft Alone
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Tufts University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Histological analysis
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Xenograft - Autogenous 1:4
Sinus grafted with a ratio of Xenograft - Autogenous 1:4
Intervention: Sinus Lift augmentation (Procedure)
Xenograft - Autogenous 1:4
Sinus grafted with a ratio of Xenograft - Autogenous 1:4
Intervention: Cone-beam computed tomography systems (CBCT) (Device)
Xenograft alone
Sinus grafted with Xenograft only
Intervention: Sinus Lift augmentation (Procedure)
Xenograft alone
Sinus grafted with Xenograft only
Intervention: Cone-beam computed tomography systems (CBCT) (Device)
Outcomes
Primary Outcomes
Histological analysis
Time Frame: 4 months from surgery
Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate
Secondary Outcomes
- Radiographic bone height gain at 4 months(4 months post sinus augmentation)
- Volumetric bone analysis 4 months post sinus augmentation(4 months from surgery)