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Bone Augmentation Techniques in Extraction Sockets

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ClinicalTrials.gov Identifier: NCT01836783
Recruitment Status : Active, not recruiting
First Posted : April 22, 2013
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
BioDlogics
Information provided by (Responsible Party):
Maninder Kaur, University of Alabama at Birmingham

Brief Summary:

The study will compare the density and strength of regenerated bone in extraction sockets after being grafted with two different materials: Bone Allograft and Bone Allograft with Amnion.

The investigators hypothesize that sockets grafted with the Amnion graft will exhibit enhanced healing patterns and will accelerate the formation of regenerated bone in the grafted areas.


Condition or disease Intervention/treatment Phase
Tooth Loss Other: Amnion Allograft Other: Allograft Not Applicable

Detailed Description:

The amniotic allograft is a cryopreserved allograft tissue matrix derived from human placental tissues recovered from live healthy donors. Amniotic tissue is an abundant source of collagen which provides an extracellular matrix to act as a natural scaffold for cellular attachment in the body; collagen provides a structural tissue matrix that facilitates cellular migration and proliferation in-vivo. The product is developed using proprietory techniques by BioDlogics, LLC. The amniotic allograft growth factors are thought to enhance formation of a supportive scaffold for regeneration, to facilitate interactions between cell types, and to influence anti-inflammatory, anti-microbial and immuno-privilege activities.

Atraumatic extractions and socket grafts will be performed. Dental implants will be inserted into the grafted areas 8 weeks post-graft. The implants will be restored and followed for 24 months post-insertion.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Study of Bone Augmentation Techniques in Extraction Sockets
Actual Study Start Date : January 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Amnion Allograft
Atraumatic tooth extractions and amnion allograft procedures
Other: Amnion Allograft
Atraumatic extraction and grafting procedures will be followed by insertion of a dental implant into the grafted area at week-8. The implant will be restored and be monitored for 24 months post-insertion. Two special dental cone-beam CT images (pre-baseline and week-7) and a minimum of 6 intraoral radiographs will be taken during the study

Active Comparator: Allograft
Atraumatic tooth extractions and allograft procedures
Other: Allograft
Atraumatic extraction and grafting procedures will be followed by insertion of a dental implant into to the grafted area at week-8. The implant will be restored and be monitored for 24 months post-insertion. Two special dental cone-beam CT images (pre-baseline and week-7) and a minimum of 6 intraoral radiographs will be taken during the study




Primary Outcome Measures :
  1. Changes in Hard Tissue Composition [ Time Frame: baseline, week-8 ]
    A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis


Secondary Outcome Measures :
  1. Changes in soft tissue healing [ Time Frame: baseline, 7 weeks, 12 months, 24 months, ]
    Clinical examination utilizing photographic data and imaging analysis software



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be a registered University of Alabama at Birmingham (UAB) dental school patient
  2. Existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
  3. Healthy enough to undergo the proposed therapy
  4. Demonstrated willingness to comply with study directions and time-line
  5. Able to consent for themselves
  6. Able to read and understand the informed consent form -

Exclusion Criteria:

  1. Pregnant or lactating at the time of enrollment
  2. Previous Malignant neoplasm
  3. Known hypersensitivity to bone grafting materials
  4. Know hypersensitivity to titanium
  5. Any medical of medication that in the opinion of the investigators may adversely affect bone healing
  6. Any indication of an inability to make autonomous decisions -

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): NCT01836783


Locations
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United States, Alabama
University of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, United States, 35294-0007
Sponsors and Collaborators
University of Alabama at Birmingham
BioDlogics
Investigators
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Principal Investigator: Maninder Kaur, BDS MPH University of Alabama at Birmingham

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Responsible Party: Maninder Kaur, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01836783     History of Changes
Other Study ID Numbers: Amnio-12
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Keywords provided by Maninder Kaur, University of Alabama at Birmingham:
Allograft
Amnion Allograft

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases