Atrophic MaxillaNCT03268512
Effect of L-PRF and A-PRF in Ridge Preservation
A study testing L-PRF and A-PRF in people with Atrophic Maxilla and Ridge Preservation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A split-mouth design study will be performed regarding the use of platelet concentrates on ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in the upper jaw (single-rooted teeth) will be recruited. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Maxilla, Ridge Preservation
- What is being tested?
- L-PRF and A-PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Aug 2015to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 3 single-rooted teeth needed to be extracted in the upper jaw
- patient in good general health as documented by self-assessment
- patients must be committed to the study and must be willing to sing the informed consent.
Who cannot join
- any systemic medical condition that could interfere with the surgical procedure or planned treatment.
- current pregnancy or breast feeding
- radiotherapy or chemotherapy in head and neck area
- intravenous and oral bisphosphonate
- patients smoking >20 cig/day
- unwillingness to return for the follow-up examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of L-PRF and A-PRF in Ridge Preservation: a Randomized Controlled Clinical Trial
A split-mouth design study will be performed regarding the use of platelet concentrates on ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate or control will be randomized by means of a computer program. The results will be analysed clinical and radiographically (CBCT). When the subject will choose for implant rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will be localized with a customized stent, fabricated with the position of the extracted teeth. VAS scales will be provided to evaluate the post-operative discomfort.
- Conditions
- Atrophic Maxilla, Ridge Preservation
- Being tested
- L-PRF, A-PRF
- Keywords
- leucocyte- and platelet rich fibrin, ridge preservation, growth factors, platelet concentrates
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRFOther
Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.
A-PRFOther
Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.
| Study group | Role | What they receive |
|---|---|---|
| L-PRF | Experimental | One socket will be filled with L-PRF membranes and covered with at least 2 L-PRF membranes. A modified horizontal mattress will be place as suture to keep the L-PRF in place. Receives: Other: L-PRF |
| A-PRF | Experimental | One socket will be filled with A-PRF membranes and covered with at least 2 A-PRF membranes. A modified horizontal mattress will be place as suture to keep the A-PRF in place. Receives: Other: A-PRF |
| Control | No intervention | The socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes horizontal width at crest -1mm
Primary outcome variables were defined as the changes in horizontal width at crest-1 mm levels.
Measured: 3 months
Secondary outcomes (1)
Changes horizontal width at crest -3 mm and 5 mm; vertical resorption; socket fill
Changes in horizontal width at crest -3 mm and 5 mm; vertical resorption at the lingual and buccal side; socket fill.
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 posted31 Aug 2017
- Study start22 Aug 2015
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic MaxillaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana CASTRO SARDA, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Ana B Castro, PhD student, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268512
- Sponsor's protocol ID
- B322201525149
- Status last verified
- Oct 2018
- First submitted
- 28 Aug 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of L-PRF and A-PRF in Ridge Preservation: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03268512
- Acronym / sponsor ID
- B322201525149
- Conditions
- Atrophic Maxilla, Ridge Preservation
- Keywords
- leucocyte- and platelet rich fibrin, ridge preservation, growth factors, platelet concentrates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 22 Aug 2015 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A split-mouth design study will be performed regarding the use of platelet concentrates on ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate or control will be randomized by means of a computer program. The results will be analysed clinical and radiographically (CBCT). When the subject will choose for implant rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will be localized with a customized stent, fabricated with the position of the extracted teeth. VAS scales will be provided to evaluate the post-operative discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L-PRF | Experimental | Other: L-PRFOne socket will be filled with L-PRF membranes and covered with at least 2 L-PRF membranes. A modified horizontal mattress will be place as suture to keep the L-PRF in place. |
| A-PRF | Experimental | Other: A-PRFOne socket will be filled with A-PRF membranes and covered with at least 2 A-PRF membranes. A modified horizontal mattress will be place as suture to keep the A-PRF in place. |
| Control | No intervention | –The socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 3 single-rooted teeth needed to be extracted in the upper jaw
- patient in good general health as documented by self-assessment
- patients must be committed to the study and must be willing to sing the informed consent.
Key exclusion criteria (6 listed)
- any systemic medical condition that could interfere with the surgical procedure or planned treatment.
- current pregnancy or breast feeding
- radiotherapy or chemotherapy in head and neck area
- intravenous and oral bisphosphonate
- patients smoking >20 cig/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 |
|---|---|---|
| L-PRFPlatelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days. | Other | L-PRF |
| A-PRFPlatelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days. | Other | A-PRF |
Primary outcome
Changes horizontal width at crest -1mm
Time frame: 3 months
Primary outcome variables were defined as the changes in horizontal width at crest-1 mm levels.
1 secondary outcome
Changes horizontal width at crest -3 mm and 5 mm; vertical resorption; socket fill
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
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Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
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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.
Ana B Castro, PhD student principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-PRF and A-PRF in people with Atrophic Maxilla and Ridge Preservation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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 11 Oct 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 horizontal width at crest -1mm (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 11 Oct 2018.