ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02532543
Recruitment Status : Recruiting
First Posted : August 25, 2015
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Dentsply International
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tooth Fractures Tooth Injuries Tooth Diseases Biological: Allograft, Membrane Biological: Alloplast, Membrane Biological: Xenograft, Membrane Biological: Membrane Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

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




Primary Outcome Measures :
  1. Volumetric osseous changes using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software [ Time Frame: 3 months ]
    The amount of change in bone volume will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software


Secondary Outcome Measures :
  1. Osseous dimensional changes [ Time Frame: 3 months ]
    The amount of horizontal and vertical bone changes will be calculated using data from DICOM images acquired by CBCT using 3D software.

  2. Soft tissue dimensional change [ Time Frame: 3 months ]
    The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation, 3 months and 6 months.

  3. Soft tissue dimensional change [ Time Frame: 6 months ]
    The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation, 3 months and 6 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532543


Contacts
Contact: Gidgetta E Jenkins, CCRC 919-537-3968 Gidget_Jenkins@dentistry.unc.edu

Locations
United States, North Carolina
University of North Carolina School of Dentistry Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Gidgetta E Jenkins, CCRC    919-537-3968    Gidget_Jenkins@dentistry.unc.edu   
Sub-Investigator: Ingeborg J De Kok, DDS MS         
Sub-Investigator: Vishal Gohel, DDS         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Dentsply International
Investigators
Principal Investigator: Jonathan Reside, DDS MS Dept. of Periodontology

Publications:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02532543     History of Changes
Other Study ID Numbers: 15-1114
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tooth Diseases
Tooth Fractures
Tooth Injuries
Stomatognathic Diseases
Wounds and Injuries