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

Sinus Augmentation Healing With Autogenous and Xenograft Mix Compared to Xenograft Alone

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 Overview

• Status: Active, not recruiting
• Conditions: Dental Implant; Bone Substitute; Maxillary Sinus Floor Augmentation; Autogenous Bone Graft
• Intervention / Treatment: Procedure: Sinus Lift augmentation; Device: Cone-beam computed tomography systems (CBCT)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xenograft - Autogenous 1:4; Sinus grafted with a ratio of Xenograft - Autogenous 1:4	Procedure: Sinus Lift augmentation; Randomised Sinus Lift augmentation either with Xenograft - Autogenous ratio 1:4 (test) or Xenograft alone (Control); Device: Cone-beam computed tomography systems (CBCT); An research only use of CBCT at visit 2 to review healing status.
Active Comparator: Xenograft alone; Sinus grafted with Xenograft only	Procedure: Sinus Lift augmentation; Randomised Sinus Lift augmentation either with Xenograft - Autogenous ratio 1:4 (test) or Xenograft alone (Control); Device: Cone-beam computed tomography systems (CBCT); An research only use of CBCT at visit 2 to review healing status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological analysis	Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate	4 months from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric bone analysis 4 months post sinus augmentation	Sinus volume calculation via CBCT analysis	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	4 months post sinus augmentation

Collaborators and Investigators

• Sponsor: Tufts University
• Investigators: Principal Investigator: Lorenzo Mordini, DDS, MS, Tufts Univeristy

Publications and helpful links

General Publications

• Al-Moraissi E, Alhajj WA, Al-Qadhi G, Christidis N. Bone Graft Osseous Changes After Maxillary Sinus Floor Augmentation: A Systematic Review. J Oral Implantol. 2022 Oct 1;48(5):464-471. doi: 10.1563/aaid-joi-D-21-00310.
• Al-Moraissi EA, Alkhutari AS, Abotaleb B, Altairi NH, Del Fabbro M. Do osteoconductive bone substitutes result in similar bone regeneration for maxillary sinus augmentation when compared to osteogenic and osteoinductive bone grafts? A systematic review and frequentist network meta-analysis. Int J Oral Maxillofac Surg. 2020 Jan;49(1):107-120. doi: 10.1016/j.ijom.2019.05.004. Epub 2019 Jun 21.
• Barone A, Crespi R, Aldini NN, Fini M, Giardino R, Covani U. Maxillary sinus augmentation: histologic and histomorphometric analysis. Int J Oral Maxillofac Implants. 2005 Jul-Aug;20(4):519-25.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Radiographic; Histology; Volume measurements
• Other Study ID Numbers: STUDY00004629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No