A Comparison of Bone Formation With Three Different Bone Graft Materials Following Sinus Graft

A Histomorphometric Analysis of Bone Formation With Three Different Bone Graft Materials Following Sinus Augmentation

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.

Study Overview

• Status: Completed
• Conditions: Inadequate Bone Height in Maxillary Posterior Area
• Intervention / Treatment: Procedure: Sinus augmentation; Drug: Bio-oss; Drug: Equimatrix; Drug: OSSIF-i sem

Detailed Description

The purpose of this investigation is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using three different bone graft materials. Null Hypothesis is that there is no histomorphometric difference in new bone formation in maxillary sinuses augmented using three different materials; anorganic bovine bone graft (Bio-Oss), anorganic equine bone graft (Equimatrix) and mineralized bone allograft (OSSIF-i sem). Patients who require sinus augmentation prior to implant placement will be selected to participate in this study. All patients will be randomly placed into three groups according to bone graft materials that will be used. Group A (Control group,n=10): Maxillary sinus augmentation using anorganic bovine bone graft (Bio-Oss), Group B (Test group,n=10):Maxillary sinus augmentation using anorganic equine bone graft (Equimatrix), and Group C (Test group,n=10):Maxillary sinus augmentation using mineralized bone allograft (OSSIF-i sem). All the patients will be treated with the same surgical technique consisting of sinus floor augmentation via a lateral approach.After a full-thickness flap reflection to expose the lateral wall of the sinus each antrostomy will be outlined with a carbide round bur and sinus membranes will be carefully elevated. If a perforation to the sinus membrane occurs, and if the perforation is < 5 mm in diameter and is able to be repaired, the surgeon will continue the procedure. Any perforation > 5 mm will be excluded from this study. Bone graft materials will be placed into the each sinus compartment for the three groups. After 8 months of healing, biopsy specimen will be collected from the previous antrostomy sites. Histomorphometric measurements of the percentage of vital bone of the area of bone. The percentage of non-bone material (allograft or xenograft) and the percentage of connective tissue will be also analyzed. Then the primary hypothesis will be analyzed statistically.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Over 18 years old who are able to read and sign written consent form.
2. Patient who has good oral hygiene (Full-mouth plaque score <25%).
3. Subject would be available for study monitoring.
4. 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.
5. Delayed implant placement approximately 8 months following sinus grafting.

Exclusion Criteria:

A medical history that will complicate the outcome of the study such as:

1. alcohol, drug dependency,
2. signs or symptoms of maxillary sinus disease,
3. current smoker,
4. history of head and neck radiation treatment,
5. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sinus augmentation using Bio-oss	Procedure: Sinus augmentation; Drug: Bio-oss; Bio-oss small granules cancellous 0.25-1mm, approximately 2g (4cc)
Experimental: Sinus augmentation using Equimatrix	Procedure: Sinus augmentation; Drug: Equimatrix; Equimatrix cancellous particle size 0.2-1mm approximately 2g (4cc)
Experimental: Sinus augmentation using OSSIF-i sem	Procedure: Sinus augmentation; Drug: OSSIF-i sem; OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 2cc x 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.	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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: American Regent, Inc.
• Investigators: Principal Investigator: Joseph Kan, DDS, MS, Loma Linda University School of Dentistry

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: July 28, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Histomorphometric Analysis; New bone Formation; Sinus Augmentation; Bone Graft Materials
• Other Study ID Numbers: 5130213

Plan for Individual participant data (IPD)

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