Bone Augmentation Techniques in Extraction Sockets

Not Applicable

Completed

• Conditions: Tooth Loss
• Interventions: Other: Allograft; Other: Amnion Allograft

• Registration Number: NCT01836783
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-22
• Primary Completion: 2021-06
• Study Completion: 2023-10
• Status Verified: 2023-12
• Results First Submitted: 2023-12-15
• Results First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Results First Posted: 2024-06-10
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 -

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allograft	Allograft	Atraumatic tooth extractions and allograft procedures
Amnion Allograft	Amnion Allograft	Atraumatic tooth extractions and amnion allograft procedures

Primary Outcome Measures

Name	Time	Method
Changes in Hard Tissue Composition	baseline to week-8	A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis

Secondary Outcome Measures

Name	Time	Method
Changes in Soft Tissue Healing	2 weeks to 7 weeks	Clinical examination utilizing photographic data and imaging analysis software

Trial Locations

Locations (1)

University of Alabama at Birmingham, School of Dentistry; 🇺🇸 Birmingham, Alabama, United States