Tooth Loss
Conditions
Keywords
Allograft, Amnion Allograft
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.
Interventions
OTHERAmnion 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
OTHERAllograft
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
Sponsors
BioDlogics
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hard Tissue Composition | baseline to week-8 | A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Soft Tissue Healing | baseline to 2 weeks | Clinical examination utilizing photographic data and imaging analysis software |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amnion Allograft Atraumatic tooth extractions and amnion allograft procedures
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 | 10 |
| Allograft Atraumatic tooth extractions and allograft procedures
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 | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Amnion Allograft | Allograft | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 9 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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
Time frame: baseline to week-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amnion Allograft | Changes in Hard Tissue Composition | 35.82 mm | Standard Deviation 13.16 |
| Allograft | Changes in Hard Tissue Composition | 31.76 mm | Standard Deviation 20.03 |
Secondary
Changes in Soft Tissue Healing
Clinical examination utilizing photographic data and imaging analysis software
Time frame: baseline to 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amnion Allograft | Changes in Soft Tissue Healing | 12.41 square millimeters | Standard Deviation 8.74 |
| Allograft | Changes in Soft Tissue Healing | 12.79 square millimeters | Standard Deviation 7.7 |
Secondary
Changes in Soft Tissue Healing
Clinical examination utilizing photographic data and imaging analysis software
Time frame: 2 weeks to 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amnion Allograft | Changes in Soft Tissue Healing | 0.87 square millimeters | Standard Deviation 1.44 |
| Allograft | Changes in Soft Tissue Healing | 1.78 square millimeters | Standard Deviation 3.06 |