Alveolar Bone LossNCT02515058
Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
A study testing PUROS (Ridge Preservation bone grafting surgery) and FDBA (Ridge Preservation bone grafting surgery) in people with Alveolar Bone Loss, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire protocol involves procedures that are… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- PUROS (Ridge Preservation bone grafting surgery) and FDBA (Ridge Preservation bone grafting surgery)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2017
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
- Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.
- Patients will are mentally incompetent, prisoners, or pregnant.
- Pregnant women or women intending to become pregnant during the study period.
- Smokers who smoke >10 cigarettes per day
- Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.
- Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health Science Center at San Antonio, School of Dentistry
San Antonio, Texas, 78229
About this study
Official title: Ridge Preservation Following Tooth Extraction Using Mineralized Freeze-Dried Bone Allograft Compared to PUROS Mineralized Bone Allograft
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Read the detailed description
The study is designed to examine histologic wound healing following ridge preservation using cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a solvent-based processing method (PUROS). This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
- Conditions
- Alveolar Bone Loss
- Being tested
- PUROS (Ridge Preservation bone grafting surgery), FDBA (Ridge Preservation bone grafting surgery)
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUROS (Ridge Preservation bone grafting surgery)Device
Ridge preservation bone grafting after tooth extraction
FDBA (Ridge Preservation bone grafting surgery)Device
Ridge preservation bone grafting after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| PUROS (Non-Freeze-Dried bone allograft) | Experimental | Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS) Receives: Device: PUROS (Ridge Preservation bone grafting surgery) |
| FDBA (Freeze-Dried bone allograft) | Active comparator | Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA) Receives: Device: FDBA (Ridge Preservation bone grafting surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Vital Bone Formation (Histological)
histologic determination of % of vital bone formation
Measured: 3 months after ridge preservation
Secondary outcomes (1)
% Residual Graft Material (Histological)
histologic determination of % of residual bone graft material
Measured: 3 months after ridge preservation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionSep 2017
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 Alveolar Bone LossStudies 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
- 44 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
- Principal investigator, Brian L Mealey, The University of Texas Health Science Center at San Antonio
- Investigators
- Brian L. Mealey, DDS, MS, Principal investigator, UT Health Science Center at San Antonio, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515058
- Sponsor's protocol ID
- 15-0552H
- Status last verified
- Nov 2017
- First submitted
- 31 Jul 2015
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Corning PJ, Mealey BL. Ridge preservation following tooth extraction using mineralized freeze-dried bone allograft compared to mineralized solvent-dehydrated bone allograft: A randomized controlled clinical trial. J Periodontol. 2019 Feb;90(2):126-133. doi: 10.1002/JPER.18-0199. Epub 2018 Sep 19.
PubMed 30161278
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation Following Tooth Extraction Using Mineralized Freeze-Dried Bone Allograft Compared to PUROS Mineralized Bone Allograft
- ClinicalTrials.gov ID
- NCT02515058
- Acronym / sponsor ID
- 15-0552H
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Posted 22 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Detailed description
The study is designed to examine histologic wound healing following ridge preservation using cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a solvent-based processing method (PUROS). This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PUROS (Non-Freeze-Dried bone allograft) | Experimental | Device: PUROS (Ridge Preservation bone grafting surgery)Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS) |
| FDBA (Freeze-Dried bone allograft) | Active comparator | Device: FDBA (Ridge Preservation bone grafting surgery)Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
- Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.
- Patients will are mentally incompetent, prisoners, or pregnant.
- Pregnant women or women intending to become pregnant during the study period.
- Smokers who smoke >10 cigarettes per day
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 |
|---|---|---|
| PUROS (Ridge Preservation bone grafting surgery)Ridge preservation bone grafting after tooth extraction | Device | PUROS (Non-Freeze-Dried bone allograft) |
| FDBA (Ridge Preservation bone grafting surgery)Ridge preservation bone grafting after tooth extraction | Device | FDBA (Freeze-Dried bone allograft) |
Primary outcome
% Vital Bone Formation (Histological)
Time frame: 3 months after ridge preservation
histologic determination of % of vital bone formation
1 secondary outcome
% Residual Graft Material (Histological)
Time frame: 3 months after ridge preservation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30161278Corning PJ, Mealey BL. Ridge preservation following tooth extraction using mineralized freeze-dried bone allograft compared to mineralized solvent-dehydrated bone allograft: A randomized controlled clinical trial. J Periodontol. 2019 Feb;90(2):126-133. doi: 10.1002/JPER.18-0199. Epub 2018 Sep 19.
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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
UT Health Science Center at San Antonio, School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUROS (Ridge Preservation bone grafting surgery) and FDBA (Ridge Preservation bone grafting surgery) in people with Alveolar Bone Loss, 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 0 inclusion and 7 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 23 Jan 2018. 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 22 Nov 2017). 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?
% Vital Bone Formation (Histological) (time frame: 3 months after ridge preservation). 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 NCT02515058, 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 23 Jan 2018.