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

NCT03059914 | Completed Results FDA Device

• 1 other identifier: 5170069
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Missing Teeth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cumulative Percentage of Bone Marrow and Fibrous Tissue

  Eight months post-op sinus augmentation

• Space

  8 months

Study Arms (2)

InterOss

EXPERIMENTAL

Maxillary sinus augmentation using ABBM Inteross ( Xenograft)

Device: InterOss

Bio-oss

ACTIVE COMPARATOR

Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)

Device: Bio-oss

Interventions

InterOss DEVICE

Anorganic bovine bone mineral - Xenograft

InterOss

Bio-oss DEVICE

Anorganic bovine bone mineral ( Xenograft)

Bio-oss

Eligibility Criteria

• Age: 18 Years - 103 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old who are able to read and sign an informed consent form.
• Patient who has good oral hygiene (Full-mouth plaque score \<25%).
• Subject would be available for study monitoring and follow-up visits.
• 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.
• Patient is a candidate for delayed implant placement approximately 8 months following sinus grafting

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University school of dentistry

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Sarat Ummethala
• Organization: Loma Linda University Health

saratdoc@yahoo.com

909 558 4983

Study Officials

• Jaime Lozada

  Loma Linda University

  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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Program Director Implant Dentistry

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: August 10, 2017
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)