A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.

A Histomorphometric Analysis of New Bone Formation Following Sinus Augmentation Using Two Different Bone Graft Materials. A Pilot Study in Humans.

The purpose of this investigator-initiated study is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using two different bone graft materials. A total of twenty, sinus augmentation via a lateral approach will be performed for subjects requiring sinus augmentation for implant placement and randomly divided into 2 groups. These subjects will receive one of two different bone graft materials: 1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss (Group B). At the time of implant placement (eight months after the sinus augmentation procedure), two bone biopsies will be collected from augmented site for the histomorphometric analysis. The percentage of vital bone will be measured and analyzed statistically, also the following will be measured: percentage of non-vital bone, percentage of non-bone material , and the percentage of connective tissue.

Study Overview

• Status: Completed
• Conditions: Missing Teeth
• Intervention / Treatment: Device: InterOss; Device: Bio-oss

Detailed Description

Bovine xenograft has been established as a gold standard in maxillary sinus floor augmentation. This study was initiated to compare two different types of bovine xenografts following maxillary sinus floor augmentation. The comparison will performed using histomorphometric analysis of bone cores removed from the grafted sites. The patients that meet the guidelines for maxillary sinus floor augmentation via lateral window approach are randomly assigned into control and test groups. The surgery is performed by the same surgeon under the same protocols. The subjects in Group A - test group receive InterOss bone graft and subjects in Group B- Control Group receive BioOss bone graft. After eight months of healing at the sites, the patients are subjected to CBCT evaluation in preparation for implant placement. At the time of implant placement the two bone cores are collected from each grafted site using trephine burs. One bone core is collected from the crestal bone that will be site of implant placement and the second bone core is collected from the lateral window area not to interfere with the implant site. These bone cores are stored intact inside the trephine burs, fixed, stored and transported to the lab for histomorphometric analysis. The following parameters are measured and reported after the histomorphometric analysis.

percentage of vital bone percentage of non-vital bone ( graft material) percentage of non-bone material percentage of connective tissue.

• Study Type: Interventional
• Enrollment (Actual): 9
• 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 to 103 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Over 18 years old who are able to read and sign an informed consent form.
2. Patient who has good oral hygiene (Full-mouth plaque score <25%).
3. Subject would be available for study monitoring and follow-up visits.
4. Patients with missing teeth in the maxillary posterior region who will require sinus augmentation for implant placement. The patients may be partially or completely edentulous.
5. Patient is a candidate for delayed implant placement approximately 8 months following sinus grafting

Exclusion Criteria:

1. Alcohol, drug dependency.
2. Signs or symptoms of chronic maxillary sinus disease.
3. Current smoker.
4. History of head and neck radiation treatment.
5. Poor health, conditions like uncontrolled diabetes, uncontrolled hypertension or other uncontrolled systemic disease.
6. Physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.
7. Also, subjects who are nursing or pregnant will be excluded from the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InterOss; Maxillary sinus augmentation using ABBM Inteross ( Xenograft)	Device: InterOss; Anorganic bovine bone mineral - Xenograft
Active Comparator: Bio-oss; Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)	Device: Bio-oss; Anorganic bovine bone mineral ( Xenograft)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of New Vital Bone.	Vital bone as seen in histology from the collected bone cores.	8 months post operative after the initial sinus augmentation surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Percentage of Bone Marrow and Fibrous Tissue	Cumulative percentage of Bone marrow and fibrous tissue as seen in histology.	Eight months post-op sinus augmentation
Space	Space seen the histology specimen not filled with either bone or fibrous tissue in the bone core specimens.	8 months

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Jaime Lozada, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2017
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia
• Other Study ID Numbers: 5170069

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes