NCT01836783

Bone Augmentation Techniques in Extraction Sockets

A Prospective Study of Bone Augmentation Techniques in Extraction Sockets

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tooth Loss

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2013-01-01
• Primary completion: 2021-06-01
• Completion: 2023-10-01
• First posted: 2013-04-22
• Last updated: 2024-06-10
• Results posted: 2024-06-10

Locations

1 site across 1 country: United States