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

NCT ID: NCT01911819

Last Updated: 2017-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-06-30

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.

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.

Conditions

Inadequate Bone Height in Maxillary Posterior Area

Keywords

Histomorphometric Analysis; New bone Formation; Sinus Augmentation; Bone Graft Materials

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sinus augmentation using Bio-oss

Sinus augmentation using Bio-oss

Group Type: EXPERIMENTAL

Sinus augmentation

Intervention Type: PROCEDURE

Bio-oss

Intervention Type: DRUG

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

Sinus augmentation using Equimatrix

Sinus augmentation using Equimatrix

Group Type: EXPERIMENTAL

Sinus augmentation

Intervention Type: PROCEDURE

Equimatrix

Intervention Type: DRUG

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

Sinus augmentation using OSSIF-i sem

Sinus augmentation using OSSIF-i sem

Group Type: EXPERIMENTAL

Sinus augmentation

Intervention Type: PROCEDURE

OSSIF-i sem

Intervention Type: DRUG

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

Interventions

Sinus augmentation

Intervention Type: PROCEDURE

Equimatrix

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

Intervention Type: DRUG

OSSIF-i sem

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

Intervention Type: DRUG

Bio-oss

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Joseph Kan, DDS

Professor of Restorative Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Kan, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University School of Dentistry

Locations

Loma Linda University School of Dentistry

Loma Linda, California, United States

Countries

United States

Other Identifiers

5130213

Identifier Type: -

Identifier Source: org_study_id