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Completed

NCT Number: NCT01836783

Bone Augmentation Techniques in Extraction Sockets

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Amnion Allograft

Other

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

Allograft

Other

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

  1. Changes in Hard Tissue Composition

    Time frame: baseline to week-8

    A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis

Secondary outcomes

  1. Changes in Soft Tissue Healing

    Time frame: baseline to 2 weeks

    Clinical examination utilizing photographic data and imaging analysis software

  2. Changes in Soft Tissue Healing

    Time frame: 2 weeks to 7 weeks

    Clinical examination utilizing photographic data and imaging analysis software

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • BioDlogics

Registry information

Official study title

A Prospective Study of Bone Augmentation Techniques in Extraction Sockets

Important dates

Study start
2013
Primary completion
2021
Study completion
2023
First posted
Apr 22, 2013
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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