Tooth LossNCT01836783
Bone Augmentation Techniques in Extraction Sockets
A study testing Amnion Allograft and Allograft in people with Tooth Loss, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Amnion Allograft and Allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a registered University of Alabama at Birmingham (UAB) dental school patient
- Existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
- Healthy enough to undergo the proposed therapy
- Demonstrated willingness to comply with study directions and time-line
- Able to consent for themselves
- Able to read and understand the informed consent form -
Who cannot join
- Pregnant or lactating at the time of enrollment
- Previous Malignant neoplasm
- Known hypersensitivity to bone grafting materials
- Know hypersensitivity to titanium
- Any medical of medication that in the opinion of the investigators may adversely affect bone healing
- Any indication of an inability to make autonomous decisions -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, 35294-0007
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Loss
- Being tested
- Amnion Allograft, Allograft
- Keywords
- Allograft, Amnion Allograft
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion AllograftOther
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
AllograftOther
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
| Study group | Role | What they receive |
|---|---|---|
| Amnion Allograft | Experimental | Atraumatic tooth extractions and amnion allograft procedures Receives: Other: Amnion Allograft |
| Allograft | Active comparator | Atraumatic tooth extractions and allograft procedures Receives: Other: Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hard Tissue Composition
A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis
Measured: baseline to week-8
Secondary outcomes (2)
Changes in Soft Tissue Healing
Clinical examination utilizing photographic data and imaging analysis software
Measured: baseline to 2 weeks
Changes in Soft Tissue Healing
Clinical examination utilizing photographic data and imaging analysis software
Measured: 2 weeks to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2021
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- BioDlogics
- Responsible party
- Principal investigator, Maninder Kaur, University of Alabama at Birmingham
- Investigators
- Maninder Kaur, BDS MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836783
- Sponsor's protocol ID
- Amnio-12
- Status last verified
- Dec 2023
- First submitted
- 17 Apr 2013
- Last updated
- 10 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Bone Augmentation Techniques in Extraction Sockets
- ClinicalTrials.gov ID
- NCT01836783
- Acronym / sponsor ID
- Amnio-12
- Conditions
- Tooth Loss
- Keywords
- Allograft, Amnion Allograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- BioDlogics
- Study start
- Jan 2013 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Posted 10 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amnion Allograft | Experimental | Other: Amnion AllograftAtraumatic tooth extractions and amnion allograft procedures |
| Allograft | Active comparator | Other: AllograftAtraumatic tooth extractions and allograft procedures |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be a registered University of Alabama at Birmingham (UAB) dental school patient
- Existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
- Healthy enough to undergo the proposed therapy
- Demonstrated willingness to comply with study directions and time-line
- Able to consent for themselves
Key exclusion criteria (6 listed)
- Pregnant or lactating at the time of enrollment
- Previous Malignant neoplasm
- Known hypersensitivity to bone grafting materials
- Know hypersensitivity to titanium
- Any medical of medication that in the opinion of the investigators may adversely affect bone healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amnion AllograftAtraumatic 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 | Other | Amnion Allograft |
| AllograftAtraumatic 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 | Other | Allograft |
Primary outcome
Changes in Hard Tissue Composition
Time frame: baseline to week-8
A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis
2 secondary outcomes
Changes in Soft Tissue Healing
Time frame: baseline to 2 weeks
Changes in Soft Tissue Healing
Time frame: 2 weeks to 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tooth Loss
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maninder Kaur, BDS MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amnion Allograft and Allograft in people with Tooth Loss, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hard Tissue Composition (time frame: baseline to week-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.