Back to resultsA Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.
Primary Purpose
Missing Teeth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
InterOss
Bio-oss
Sponsored by
About this trial
This is an interventional treatment trial for Missing Teeth
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Loma Linda University school of dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
InterOss
Bio-oss
Arm Description
Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Outcomes
Primary Outcome Measures
Percentage of new vital bone
Vital bone as seen in histology
Secondary Outcome Measures
Full Information
NCT ID
NCT03059914
First Posted
February 16, 2017
Last Updated
November 9, 2020
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT03059914
Brief Title
A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.
Official Title
A Histomorphometric Analysis of New Bone Formation Following Sinus Augmentation Using Two Different Bone Graft Materials. A Pilot Study in Humans.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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 (xenograft), and the percentage of connective tissue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
InterOss
Arm Type
Experimental
Arm Description
Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
Arm Title
Bio-oss
Arm Type
Active Comparator
Arm Description
Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Intervention Type
Device
Intervention Name(s)
InterOss
Intervention Description
Anorganic bovine bone mineral - Xenograft
Intervention Type
Device
Intervention Name(s)
Bio-oss
Intervention Description
Anorganic bovine bone mineral ( Xenograft)
Primary Outcome Measure Information:
Title
Percentage of new vital bone
Description
Vital bone as seen in histology
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
103 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Lozada
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University school of dentistry
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.
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