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

Not Applicable

Recruiting

• Conditions: Maxillary Sinus Floor Augmentation; Autogenous Bone Graft; Dental Implant; Bone Substitute
• Interventions: Procedure: Sinus Lift augmentation; Device: Cone-beam computed tomography systems (CBCT)

• Registration Number: NCT06247098
• Lead Sponsor: Tufts University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Study Start: 2024-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2027-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xenograft - Autogenous 1:4	Cone-beam computed tomography systems (CBCT)	Sinus grafted with a ratio of Xenograft - Autogenous 1:4
Xenograft alone	Cone-beam computed tomography systems (CBCT)	Sinus grafted with Xenograft only
Xenograft - Autogenous 1:4	Sinus Lift augmentation	Sinus grafted with a ratio of Xenograft - Autogenous 1:4
Xenograft alone	Sinus Lift augmentation	Sinus grafted with Xenograft only

Primary Outcome Measures

Name	Time	Method
Histological analysis	4 months from surgery	Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate

Secondary Outcome Measures

Name	Time	Method
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
Volumetric bone analysis 4 months post sinus augmentation	4 months from surgery	Sinus volume calculation via CBCT analysis

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States