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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
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
- 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
- Changes in soft tissue healing [ Time Frame: baseline, 7 weeks, 12 months, 24 months, ]Clinical examination utilizing photographic data and imaging analysis software
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
|United States, Alabama|
|University of Alabama at Birmingham, School of Dentistry|
|Birmingham, Alabama, United States, 35294-0007|
|Principal Investigator:||Maninder Kaur, BDS MPH||University of Alabama at Birmingham|