Bone Augmentation Techniques in Extraction Sockets

A Prospective Study of 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.

Study Overview

• Status: Completed
• Conditions: Tooth Loss
• Intervention / Treatment: Other: Amnion Allograft; Other: Allograft

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • University of Alabama at Birmingham, School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Soft Tissue Healing	Clinical examination utilizing photographic data and imaging analysis software	baseline to 2 weeks
Changes in Soft Tissue Healing	Clinical examination utilizing photographic data and imaging analysis software	2 weeks to 7 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: BioDlogics
• Investigators: Principal Investigator: Maninder Kaur, BDS MPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 19, 2013
• First Posted (Estimated): April 22, 2013

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Allograft; Amnion Allograft
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: Amnio-12