NCT01911819

Brief Summary

The purpose of this study is to compare new bone formation following bone graft in sinus using three different commercially available bone graft materials. The study hypothesis is that there is no difference in new bone formation among three bone graft materials under microscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 13, 2017

Completed
Last Updated

December 13, 2017

Status Verified

November 1, 2017

Enrollment Period

2.5 years

First QC Date

July 18, 2013

Results QC Date

August 10, 2017

Last Update Submit

November 9, 2017

Conditions

Inadequate Bone Height in Maxillary Posterior Area

Keywords

Histomorphometric AnalysisNew bone FormationSinus AugmentationBone Graft Materials

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Vital Bone in a Total Amount of a Bone Specimen

    Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.

    24months

Secondary Outcomes (1)

  • The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.

    24months

Study Arms (3)

Sinus augmentation using Bio-oss

EXPERIMENTAL

Sinus augmentation using Bio-oss

Procedure: Sinus augmentationDrug: Bio-oss

Sinus augmentation using Equimatrix

EXPERIMENTAL

Sinus augmentation using Equimatrix

Procedure: Sinus augmentationDrug: Equimatrix

Sinus augmentation using OSSIF-i sem

EXPERIMENTAL

Sinus augmentation using OSSIF-i sem

Procedure: Sinus augmentationDrug: OSSIF-i sem

Interventions

Sinus augmentationPROCEDURE
Sinus augmentation using Bio-ossSinus augmentation using EquimatrixSinus augmentation using OSSIF-i sem
EquimatrixDRUG

Equimatrix cancellous particle size 0.2-1mm approximately 2g (4cc)

Sinus augmentation using Equimatrix
OSSIF-i semDRUG

OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 2cc x 2

Sinus augmentation using OSSIF-i sem
Bio-ossDRUG

Bio-oss small granules cancellous 0.25-1mm, approximately 2g (4cc)

Sinus augmentation using Bio-oss

Eligibility Criteria

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

You may qualify if:

  • Over 18 years old who are able to read and sign written consent form.
  • Patient who has good oral hygiene (Full-mouth plaque score \<25%).
  • Subject would be available for study monitoring.
  • Patients with missing teeth in the maxillary posterior region who will require sinus augmentation f or implant placement. The patients may be partially or completely edentulous.
  • Delayed implant placement approximately 8 months following sinus grafting.

You may not qualify if:

  • A medical history that will complicate the outcome of the study such as:
  • alcohol, drug dependency,
  • signs or symptoms of maxillary sinus disease,
  • current smoker,
  • history of head and neck radiation treatment,
  • poor health or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University School of Dentistry

Loma Linda, California, 92350, United States

Location

MeSH Terms

Interventions

Sinus Floor AugmentationequimatrixBio-Oss

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeBone TransplantationOrthopedic ProceduresDentistry

Results Point of Contact

Title
Prof. Joseph Kan
Organization
Loma Linda University
jkan@llu.edu
(909) 558-4980

Study Officials

  • Joseph Kan, DDS, MS

    Loma Linda University School of Dentistry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Restorative Dentistry

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 30, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 13, 2017

Results First Posted

December 13, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)