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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Loma Linda University
Sponsor:
Collaborator:
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
Joseph Kan, DDS, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01911819
First received: July 18, 2013
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Inadequate Bone Height in Maxillary Posterior Area
Procedure: Sinus augmentation
Drug: Equimatrix
Drug: OSSIF-i sem
Drug: Bio-oss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Histomorphometric Analysis of Bone Formation With Three Different Bone Graft Materials Following Sinus Augmentation

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • A histomorphometric measurement of the percentage of vital bone in a total amount of bone. [ Time Frame: 12months ] [ Designated as safety issue: No ]
    Biopsy will be taken 8 months after sinus augmentation procedure, then sent to a laboratory for histomorphometric analysis.


Secondary Outcome Measures:
  • A histomorphometric measurement of the percentage of non-vital bone and connective tissue. [ Time Frame: 12months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sinus augmentation using Bio-oss
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
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911819

Contacts
Contact: Joseph Kan, DDS,MS 909-558-8427 jkan@llu.edu
Contact: Mina Nishimoto, DDS 909-705-2110 mnishimoto@llu.edu

Locations
United States, California
Loma Linda University School of Dentistry Recruiting
Loma Linda, California, United States, 92350
Contact: Joseph Kan, DDS, MS    909-558-8427    jkan@llu.edu   
Contact: Mina Nishimoto, DDS    909-705-2110    mnishimoto@llu.edu   
Sponsors and Collaborators
Loma Linda University
Luitpold Pharmaceuticals
Investigators
Principal Investigator: Joseph Kan, DDS, MS Loma Linda University School of Dentistry
  More Information

No publications provided

Responsible Party: Joseph Kan, DDS, Professor of Restorative Dentistry, Loma Linda University
ClinicalTrials.gov Identifier: NCT01911819     History of Changes
Other Study ID Numbers: 2EQX13005
Study First Received: July 18, 2013
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Histomorphometric Analysis
New bone Formation
Sinus Augmentation
Bone Graft Materials

ClinicalTrials.gov processed this record on August 21, 2014