Bone Augmentation Techniques in Extraction Sockets
Primary Purpose
Tooth Loss
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amnion Allograft
Allograft
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss focused on measuring Allograft, Amnion Allograft
Eligibility Criteria
Inclusion Criteria:
- Be a registered University of Alabama at Birmingham (UAB) dental school patient
- Existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
- Healthy enough to undergo the proposed therapy
- Demonstrated willingness to comply with study directions and time-line
- Able to consent for themselves
- Able to read and understand the informed consent form -
Exclusion Criteria:
- Pregnant or lactating at the time of enrollment
- Previous Malignant neoplasm
- Known hypersensitivity to bone grafting materials
- Know hypersensitivity to titanium
- Any medical of medication that in the opinion of the investigators may adversely affect bone healing
- Any indication of an inability to make autonomous decisions -
Sites / Locations
- University of Alabama at Birmingham, School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amnion Allograft
Allograft
Arm Description
Atraumatic tooth extractions and amnion allograft procedures
Atraumatic tooth extractions and allograft procedures
Outcomes
Primary Outcome Measures
Changes in Hard Tissue Composition
A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis
Secondary Outcome Measures
Changes in soft tissue healing
Clinical examination utilizing photographic data and imaging analysis software
Full Information
NCT ID
NCT01836783
First Posted
April 17, 2013
Last Updated
June 30, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
BioDlogics
1. Study Identification
Unique Protocol Identification Number
NCT01836783
Brief Title
Bone Augmentation Techniques in Extraction Sockets
Official Title
A Prospective Study of Bone Augmentation Techniques in Extraction Sockets
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2013 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
BioDlogics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
Allograft, Amnion Allograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amnion Allograft
Arm Type
Experimental
Arm Description
Atraumatic tooth extractions and amnion allograft procedures
Arm Title
Allograft
Arm Type
Active Comparator
Arm Description
Atraumatic tooth extractions and allograft procedures
Intervention Type
Other
Intervention Name(s)
Amnion Allograft
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Allograft
Intervention Description
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 Measure Information:
Title
Changes in Hard Tissue Composition
Description
A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis
Time Frame
baseline, week-8
Secondary Outcome Measure Information:
Title
Changes in soft tissue healing
Description
Clinical examination utilizing photographic data and imaging analysis software
Time Frame
baseline, 7 weeks, 12 months, 24 months,
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be a registered University of Alabama at Birmingham (UAB) dental school patient
Existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
Healthy enough to undergo the proposed therapy
Demonstrated willingness to comply with study directions and time-line
Able to consent for themselves
Able to read and understand the informed consent form -
Exclusion Criteria:
Pregnant or lactating at the time of enrollment
Previous Malignant neoplasm
Known hypersensitivity to bone grafting materials
Know hypersensitivity to titanium
Any medical of medication that in the opinion of the investigators may adversely affect bone healing
Any indication of an inability to make autonomous decisions -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maninder Kaur, BDS MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham, School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bone Augmentation Techniques in Extraction Sockets
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