Tooth ExtractionNCT01588444
Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft
A study testing cortical FDBA and Cancellous FDBA in people with Tooth Extraction, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- cortical FDBA and Cancellous FDBA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jul 2012
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single rooted tooth requiring extraction with future dental implant placement
Who cannot join
- smoking > 10 cigarettes per day poorly controlled diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health Science Center Dental School
San Antonio, Texas, 78229
About this study
Official title: Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Cortical Versus Cancellous Freeze Dried Bone Allograft
The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.
- Conditions
- Tooth Extraction
- Being tested
- cortical FDBA, Cancellous FDBA
- Keywords
- tooth extraction, bone grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cortical FDBADevice
cortical mineralized freeze-dried bone allograft
Cancellous FDBADevice
CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
| Study group | Role | What they receive |
|---|---|---|
| cancellous FDBA (LifeNet) | Experimental | grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) Receives: Device: Cancellous FDBA |
| cortical FDBA (LifeNet) | Experimental | CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) Receives: Device: cortical FDBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic Percentage of Vital Bone Formation
Histologic percentage of vital bone formation in bone cores
Measured: 18-20 weeks after grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionJul 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian L Mealey, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588444
- Sponsor's protocol ID
- HSC20110039H
- Status last verified
- Oct 2015
- First submitted
- 16 Mar 2012
- Last updated
- 22 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eskow AJ, Mealey BL. Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. J Periodontol. 2014 Apr;85(4):514-24. doi: 10.1902/jop.2013.130178. Epub 2013 May 31.
PubMed 23725026
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Cortical Versus Cancellous Freeze Dried Bone Allograft
- ClinicalTrials.gov ID
- NCT01588444
- Acronym / sponsor ID
- HSC20110039H
- Conditions
- Tooth Extraction
- Keywords
- tooth extraction, bone grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cancellous FDBA (LifeNet) | Experimental | Device: Cancellous FDBAgrafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) |
| cortical FDBA (LifeNet) | Experimental | Device: cortical FDBACORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- single rooted tooth requiring extraction with future dental implant placement
Key exclusion criteria (1 listed)
- smoking > 10 cigarettes per day poorly controlled diabetes
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 |
|---|---|---|
| cortical FDBAcortical mineralized freeze-dried bone allograft | Device | cortical FDBA (LifeNet) |
| Cancellous FDBACANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) | Device | cancellous FDBA (LifeNet) |
Primary outcome
Histologic Percentage of Vital Bone Formation
Time frame: 18-20 weeks after grafting
Histologic percentage of vital bone formation in bone cores
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23725026Eskow AJ, Mealey BL. Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. J Periodontol. 2014 Apr;85(4):514-24. doi: 10.1902/jop.2013.130178. Epub 2013 May 31.
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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.
Brian L Mealey, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cortical FDBA and Cancellous FDBA in people with Tooth Extraction, run by The University of Texas Health Science Center at San Antonio 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 1 inclusion and 1 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 22 Oct 2015. 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 6 Oct 2014). 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?
Histologic Percentage of Vital Bone Formation (time frame: 18-20 weeks after grafting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588444, which also lists 1 linked publication.
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 22 Oct 2015; AzTrials last refreshed its copy on 1 Nov 2026.