Bone Augmentation Techniques in Extraction Sockets

Tooth Loss Clinical Trial

Official title:

A Prospective Study of Bone Augmentation Techniques in Extraction Sockets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836783
• Other study ID #: Amnio-12
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 2023

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2023
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Tooth Loss

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham, School of Dentistry	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	BioDlogics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Soft Tissue Healing	Clinical examination utilizing photographic data and imaging analysis software	baseline to 2 weeks
Secondary	Changes in Soft Tissue Healing	Clinical examination utilizing photographic data and imaging analysis software	2 weeks to 7 weeks