Bone Augmentation Techniques in Extraction Sockets

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Assessment of Bone Augmentation in Post-Extraction Sockets

NCT00641316

Unrestorable Dentition Post-Extraction Sockets

COMPLETED NA

Bone Material's Histomorphometric Analysis In Socket Preservation

NCT06740110

Socket Preservation

ACTIVE_NOT_RECRUITING NA

Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials

NCT02532543

Tooth Fractures Tooth Injuries Tooth Diseases

TERMINATED NA

Comparative Analysis of 2 Bone Graft Materials in Socket Preservation

NCT07344025

Socket Preservation Alveolar Ridge Augmentation Dental Implants

RECRUITING NA

Biomaterial Clinical Performance in a Socket Preservation Model

NCT04789759

Bone Loss Alveolar Bone Resorption

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amnion Allograft

Atraumatic tooth extractions and amnion allograft procedures

Group Type EXPERIMENTAL

Amnion Allograft

Intervention Type 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

Atraumatic tooth extractions and allograft procedures

Group Type ACTIVE_COMPARATOR

Allograft

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes