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

Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT03059914
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
34.5
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.
Condition or Disease Intervention/Treatment Phase
  • Device: InterOss
  • Device: Bio-oss
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Histomorphometric Analysis of New Bone Formation Following Sinus Augmentation Using Two Different Bone Graft Materials. A Pilot Study in Humans.
Actual Study Start Date :
Aug 10, 2017
Actual Primary Completion Date :
Jun 26, 2020
Actual Study Completion Date :
Jun 26, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Percentage of new vital bone [8 months]

    Vital bone as seen in histology

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 103 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University school of dentistry Loma Linda California United States 92350

Sponsors and Collaborators

  • Loma Linda University

Investigators

  • Principal Investigator: Jaime Lozada, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT03059914
Other Study ID Numbers:
  • 5170069
First Posted:
Feb 23, 2017
Last Update Posted:
Nov 12, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Tooth Loss
Anodontia

Study Results

No Results Posted as of Nov 12, 2020