Overview

This trial is active, not recruiting.

Condition tooth loss
Treatments amnion allograft, allograft
Sponsor University of Alabama at Birmingham
Collaborator BioDlogics
Start date January 2013
End date June 2016
Trial size 17 participants
Trial identifier NCT01836783, Amnio-12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Atraumatic tooth extractions and amnion allograft procedures
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)
Atraumatic tooth extractions and allograft procedures
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 Outcomes

Measure
Changes in Hard Tissue Composition
time frame: baseline, week-8

Secondary Outcomes

Measure
Changes in soft tissue healing
time frame: baseline, 7 weeks, 12 months, 24 months,

Eligibility Criteria

Male or female participants at least 19 years old.

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 -

Additional Information

Official title A Prospective Study of Bone Augmentation Techniques in Extraction Sockets
Principal investigator Maninder Kaur, BDS MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.