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

N/AActive Not RecruitingNCT06247098

Tufts University10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Maxillary Sinus Floor Augmentation Dental Implant Bone Substitute Autogenous Bone Graft

Interventions

Sinus Lift augmentationPROCEDURE

Randomised Sinus Lift augmentation either with Xenograft - Autogenous ratio 1:4 (test) or Xenograft alone (Control)

Cone-beam computed tomography systems (CBCT)DEVICE

An research only use of CBCT at visit 2 to review healing status.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Histological analysis

Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate

Time frame: 4 months from surgery

Secondary Outcomes

Volumetric bone analysis 4 months post sinus augmentation

Sinus volume calculation via CBCT analysis

Time frame: 4 months from surgery

Radiographic bone height gain at 4 months

Residual alveolar crest Final alveolar crest height at 4 months Initial height of graft immediately post graft placement Vertical bone material resorption

Time frame: 4 months post sinus augmentation

Data from ClinicalTrials.gov

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