Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials

December 6, 2019 updated by: University of North Carolina, Chapel Hill

Prospective, Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials (SYMBIOS CORTICAL-CANCELLOUS GRANULE MIX; SYMBIOS OSTEOGRAF LD-300; OSTEOGRAF/N-300) Following Tooth Extraction

This study is intended to provide statistically robust evidence that Symbios Demineralized Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. Additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. It is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of informed consent
  2. ≥ 18 years and ≤ 75 years
  3. Good physical health (ASAI/II)
  4. Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
  5. Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (> 3 mm) and/or significant soft tissue deficiencies

Exclusion Criteria:

  1. Buccal plate dehiscence and/or fenestration >3mm at study site following extraction
  2. Untreated rampant caries and uncontrolled periodontal disease
  3. Inadequate oral hygiene (estimated plaque score >20%)
  4. Smokers using more than 10 cigarettes or equivalent per day
  5. Smokeless tobacco use or e-cigarette use

  6. Compromised physical health and/or uncontrolled or severe systemic diseases including:

    ASA III/IV Metabolic bone disease History of malignancy History or radiotherapy or chemotherapy for malignancy in the past 5 years History of autoimmune disease Long-term steroidal or antibiotic therapy Uncontrolled diabetes Known alcohol or drug abuse

  7. Systemic or local disease or condition that would compromise post-operative healing
  8. Use of any substance or medication that will influence bone metabolism
  9. Known pregnancy
  10. Unable or unwilling to return for follow-up visits for a period of 6 months
  11. Unlikely to be able to comply with study procedures according to Investigators judgement
  12. Involvement in the planning and conduct of the study
  13. Previous enrollment or randomization of treatment in the present study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A- Allograft, Membrane
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Biological: Allograft, Membrane
Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Active Comparator: Group B- Alloplast, Membrane
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Biological: Alloplast, Membrane
Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Active Comparator: Group C- Xenograft, Membrane
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Biological: Xenograft, Membrane
Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
Active Comparator: Group D- Membrane
Symbios OsteoShield Collagen Resorbable Membrane
Biological: Membrane
Membrane - Symbios OsteoShield Collagen Resorbable Membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Mean Change in Bone Volume
Time Frame: time of extraction to 3 months post extraction
The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software
time of extraction to 3 months post extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Osseous Dimensional Changes-Horizontal
Time Frame: time of extraction to 3 months post extraction
The amount of linear (mm) horizontal bone change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal plate. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
time of extraction to 3 months post extraction
Mean Osseous Dimensional Changes-Vertical
Time Frame: time of extraction to 3 months post extraction
The amount of linear (mm) vertical bone change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
time of extraction to 3 months post extraction
Total Mean Change in Soft Tissue Volume
Time Frame: time of extraction to 3 months post extraction
The change in soft tissue volume at 3 months following tooth extraction will be assessed through the use of 3D scans of patient dental models at two time points following extraction and ridge preservation at 3 months.
time of extraction to 3 months post extraction
Mean Soft Tissue Dimensional Changes-Horizontal
Time Frame: time of extraction to 3 months post extraction
The amount of linear (mm) horizontal soft tissue change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal bone plate. Data will be calculated using data from DICOM images acquired by CBCT and overlaid 3D scans of patient dental models using 3D software.
time of extraction to 3 months post extraction
Mean Soft Tissue Dimensional Changes-Vertical
Time Frame: time of extraction to 3 months post extraction
The amount of linear (mm) vertical soft tissue change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from 3D scans of patient dental models using 3D software.
time of extraction to 3 months post extraction
Soft Tissue Dimensional Change at Month 6
Time Frame: Month 6
The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation at 6 months.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Dentsply International

Investigators

  • Principal Investigator: Jonathan Reside, DDS MS, Dept. of Periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

February 12, 2018

Study Completion (Actual)

February 12, 2018

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimate)

August 25, 2015

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-1114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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