Alveolar Ridge PreservationNCT03043885
Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft
A study testing FDBA, PRF and Blood Clot in people with Alveolar Ridge Preservation, run by University of California, San Francisco.
Trial summary
Improved predictability and quality of bone healing after a tooth is removed is clinically relevant, in that, it improves our ability to achieve successful implant placement at edentulous sites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- FDBA, PRF and Blood Clot
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2015to 1 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single rooted teeth requiring extraction
- Intact buccal and lingual plate within approximately 3-4 mm from gingival crest
- No clinical or radiographic signs of periapical pathology
- Acceptable oral hygiene
Who cannot join
- Unable to comply with necessary scheduled visits
- Poor oral hygiene
- Failing/failed endodontic treatment with history/presence of sinus tracts
- Pregnant woman or patients who intend to become pregnant
- Tobacco use
- Immunosuppressed
- Type I or type II diabetes
- Patient with any blood disorder
About this study
Official title: Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft: A Comparative Clinical, Histological, and Micro-computed Tomography Study
Improved predictability and quality of bone healing after a tooth is removed is clinically relevant, in that, it improves our ability to achieve successful implant placement at edentulous sites. Currently, a variety of grafting materials and biologic agents are utilized clinically to improve bone healing and provide sufficient dimensions of bone to support a dental implant. Platelet rich fibrin (PRF) is one such product that can be used for this application. PRF is a concentrated blood product attained from the patient's own blood consisting of a natural bioscaffold with integrated growth factors capable of sustained release. Once processed, PRF is implanted back into the patient at the wound or defect site to encourage healing. The literature regarding PRF is currently dominated by heterogeneous applications of PRF for reparative and regenerative therapies without a consensus of its clinical efficacy and appropriate application. In this clinical study, PRF will be evaluated to ascertain its clinical efficacy in improving bone formation and alveolar dimensional stability after tooth extraction. A classic bone grafting material used for this purpose, freeze dried bone allograft (FDBA), will be incorporated with the PRF or compared directly to PRF alone. It is hypothesized that the natural scaffold and incorporated growth factors of PRF augmented with the solubility resistance of FDBA will function as an ideal bioscaffold to promote bone healing to a greater extent compared to PRF, FDBA, or blood clot alone.
Read the detailed description
This is a randomized controlled clinical study evaluating the efficacy of four treatment modalities for ridge preservation after extraction of a tooth in preparation for dental implant placement. After tooth extraction the alveolar crest remodels during healing with reductions in vertical and horizontal dimensions. The resulting reduced dimensions after healing of the alveolar crest may be inadequate to successfully place a dental implant to replace the missing tooth. In an attempt to minimize the reductions in dimensions and provide mature healthy bone to support the dental implant, different ridge preservation techniques (treatment of the extraction socket) have been utilized.
Forty subject from the UCSF Dental School who will be having a tooth extracted and replaced with a dental implant will be randomly assigned into the four ridge preservation treatment groups. After three months of healing bone samples from the ridge preservation site will be collected during the implant placement when bone is removed during the osteotomy preparation for the implant. Samples will be evaluated for the extent and quality of bone healing via histomorphometric and micro-CT analysis. Clinical measures of alveolar ridge dimensions will be taken before and after tooth extraction to determine extent of dimensional stability under the different treatment groups.
The four treatments modalities for ridge preservation include autologous platelet rich fibrin (PRF), PRF+freeze dried bone allograft (FDBA), FDBA, collagen barrier membrane. Subjects will be enrolled in the study from the time the socket treated to the time of implant placement (3 months). The results of this study will help to elucidate the extent and quality of bone healing using four different methods for ridge preservation in preparation for implant placement. Further, this study will advance our knowledge of PRF, an autologous sourced blood product used in dentoalveolar surgeries with proven in-vitro qualities but still requiring more extensive clinical testing to demonstrate its full clinical utility.
- Conditions
- Alveolar Ridge Preservation
- Being tested
- FDBA, PRF, Blood Clot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDBADevice
Graft material used to graft extraction socket
PRFDevice
Autologous blood product used to graft extraction socket
Blood ClotProcedure or surgery
Surgical treatment of extraction socket without addition of graft material
| Study group | Role | What they receive |
|---|---|---|
| PRF | Experimental | Not described Receives: Device: PRF |
| PRF+FDBA | Experimental | Not described Receives: Device: FDBA; Device: PRF |
| FDBA | Active comparator | Not described Receives: Device: FDBA |
| Blood Clot | Active comparator | Not described Receives: Procedure: Blood Clot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Vital Bone
Percentage of vital bone at healed extraction socket
Measured: 3 months
Secondary outcomes (1)
Bone Mineral Density
The bone mineral density (measured via micro-CT) at healed extraction sockets
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start5 Jan 2015
- Primary completion9 May 2016
- Study completion1 Mar 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.
- Other trials for Alveolar Ridge PreservationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ryder, University of California, San Francisco
- Investigators
- Mark Ryder, DDS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043885
- Sponsor's protocol ID
- 14-13360
- Status last verified
- Nov 2018
- First submitted
- 1 Feb 2017
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft: A Comparative Clinical, Histological, and Micro-computed Tomography Study
- ClinicalTrials.gov ID
- NCT03043885
- Acronym / sponsor ID
- 14-13360
- Conditions
- Alveolar Ridge Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 9 May 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 5 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improved predictability and quality of bone healing after a tooth is removed is clinically relevant, in that, it improves our ability to achieve successful implant placement at edentulous sites. Currently, a variety of grafting materials and biologic agents are utilized clinically to improve bone healing and provide sufficient dimensions of bone to support a dental implant. Platelet rich fibrin (PRF) is one such product that can be used for this application. PRF is a concentrated blood product attained from the patient's own blood consisting of a natural bioscaffold with integrated growth factors capable of sustained release. Once processed, PRF is implanted back into the patient at the wound or defect site to encourage healing. The literature regarding PRF is currently dominated by heterogeneous applications of PRF for reparative and regenerative therapies without a consensus of its clinical efficacy and appropriate application. In this clinical study, PRF will be evaluated to ascertain its clinical efficacy in improving bone formation and alveolar dimensional stability after tooth extraction. A classic bone grafting material used for this purpose, freeze dried bone allograft (FDBA), will be incorporated with the PRF or compared directly to PRF alone. It is hypothesized that the natural scaffold and incorporated growth factors of PRF augmented with the solubility resistance of FDBA will function as an ideal bioscaffold to promote bone healing to a greater extent compared to PRF, FDBA, or blood clot alone.
Detailed description
This is a randomized controlled clinical study evaluating the efficacy of four treatment modalities for ridge preservation after extraction of a tooth in preparation for dental implant placement. After tooth extraction the alveolar crest remodels during healing with reductions in vertical and horizontal dimensions. The resulting reduced dimensions after healing of the alveolar crest may be inadequate to successfully place a dental implant to replace the missing tooth. In an attempt to minimize the reductions in dimensions and provide mature healthy bone to support the dental implant, different ridge preservation techniques (treatment of the extraction socket) have been utilized.
Forty subject from the UCSF Dental School who will be having a tooth extracted and replaced with a dental implant will be randomly assigned into the four ridge preservation treatment groups. After three months of healing bone samples from the ridge preservation site will be collected during the implant placement when bone is removed during the osteotomy preparation for the implant. Samples will be evaluated for the extent and quality of bone healing via histomorphometric and micro-CT analysis. Clinical measures of alveolar ridge dimensions will be taken before and after tooth extraction to determine extent of dimensional stability under the different treatment groups.
The four treatments modalities for ridge preservation include autologous platelet rich fibrin (PRF), PRF+freeze dried bone allograft (FDBA), FDBA, collagen barrier membrane. Subjects will be enrolled in the study from the time the socket treated to the time of implant placement (3 months). The results of this study will help to elucidate the extent and quality of bone healing using four different methods for ridge preservation in preparation for implant placement. Further, this study will advance our knowledge of PRF, an autologous sourced blood product used in dentoalveolar surgeries with proven in-vitro qualities but still requiring more extensive clinical testing to demonstrate its full clinical utility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRF | Experimental | Device: PRF |
| PRF+FDBA | Experimental | Device: FDBA, Device: PRF |
| FDBA | Active comparator | Device: FDBA |
| Blood Clot | Active comparator | Procedure: Blood Clot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single rooted teeth requiring extraction
- Intact buccal and lingual plate within approximately 3-4 mm from gingival crest
- No clinical or radiographic signs of periapical pathology
- Acceptable oral hygiene
Key exclusion criteria (8 listed)
- Unable to comply with necessary scheduled visits
- Poor oral hygiene
- Failing/failed endodontic treatment with history/presence of sinus tracts
- Pregnant woman or patients who intend to become pregnant
- Tobacco use
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 |
|---|---|---|
| FDBAGraft material used to graft extraction socket | Device | FDBA, PRF+FDBA |
| PRFAutologous blood product used to graft extraction socket | Device | PRF, PRF+FDBA |
| Blood ClotSurgical treatment of extraction socket without addition of graft material | Procedure or surgery | Blood Clot |
Primary outcome
Percentage of Vital Bone
Time frame: 3 months
Percentage of vital bone at healed extraction socket
1 secondary outcome
Bone Mineral Density
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Mark Ryder, DDS principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing FDBA, PRF and Blood Clot in people with Alveolar Ridge Preservation, run by University of California, San Francisco.
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 4 inclusion and 8 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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 5 Dec 2018). 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?
Percentage of Vital Bone (time frame: 3 months). 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 5 Dec 2018.