Clinical trial NCT01836783: Bone Augmentation Techniques in Extraction Sockets
Official title: A Prospective Study of Bone Augmentation Techniques in Extraction Sockets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Keywords: Allograft
Amnion Allograft
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: BioDlogics
First posted: 2013-04-22
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Changes in Hard Tissue Composition
timeFrame: baseline to week-8
Secondary outcomes:
measure: Changes in Soft Tissue Healing
timeFrame: baseline to 2 weeks
measure: Changes in Soft Tissue Healing
timeFrame: 2 weeks to 7 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, School of Dentistry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Maninder Kaur, BDS MPH
role: PRINCIPAL_INVESTIGATOR
References: