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

Tufts University

Status: Enrolling

Conditions: Bone Substitute; Dental Implant; Autogenous Bone Graft; Maxillary Sinus Floor Augmentation

Treatments: Device: Cone-beam computed tomography systems (CBCT); Procedure: Sinus Lift augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT06247098

STUDY00004629

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Xenograft - Autogenous 1:4

Experimental group

Description:

Sinus grafted with a ratio of Xenograft - Autogenous 1:4

Treatment:

Procedure: Sinus Lift augmentation

Device: Cone-beam computed tomography systems (CBCT)

Xenograft alone

Active Comparator group

Description:

Sinus grafted with Xenograft only

Treatment:

Procedure: Sinus Lift augmentation

Device: Cone-beam computed tomography systems (CBCT)