NCT06247098

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
25mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Sep 2024May 2028

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 30, 2024

Last Update Submit

January 21, 2026

Conditions

Maxillary Sinus Floor AugmentationDental ImplantBone SubstituteAutogenous Bone Graft

Keywords

HistologyVolume measurementsRadiographic

Outcome Measures

Primary Outcomes (1)

  • Histological analysis

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

    4 months from surgery

Secondary Outcomes (2)

  • Volumetric bone analysis 4 months post sinus augmentation

    4 months from surgery

  • Radiographic bone height gain at 4 months

    4 months post sinus augmentation

Study Arms (2)

Xenograft - Autogenous 1:4

EXPERIMENTAL

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

Procedure: Sinus Lift augmentationDevice: Cone-beam computed tomography systems (CBCT)

Xenograft alone

ACTIVE COMPARATOR

Sinus grafted with Xenograft only

Procedure: Sinus Lift augmentationDevice: Cone-beam computed tomography systems (CBCT)

Interventions

Sinus Lift augmentationPROCEDURE

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

Xenograft - Autogenous 1:4Xenograft alone
Cone-beam computed tomography systems (CBCT)DEVICE

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

Xenograft - Autogenous 1:4Xenograft alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • to 100 year old

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Related Publications (3)

  • 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.

    PMID: 35881815BACKGROUND

  • 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.

    PMID: 31230768BACKGROUND

  • 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.

    PMID: 16161735BACKGROUND

Study Officials

  • Lorenzo Mordini, DDS, MS

    Tufts Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)