Bone Loss, AlveolarL-PRFNCT03408418
L-PRF in Alveolar Ridge Preservation
A study testing Platelet-rich fibrin in people with Bone Loss, Alveolar, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after dental extractions is still a matter of debate. The available literature suggests that L-PRF performs positive effect to improve alveolar preservation resulting in less bone resorption on extraction sockets. Read more about this study
- Who is it for?
- Ages 17 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Alveolar
- What is being tested?
- Platelet-rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2018to 1 Mar 2019
- 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 17 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- (1) Health patients, American Society of Anesthesiologists (ASA) I or II
- (2) Patients who need to submit tooth extraction (pre-molar, canine and incisor teeth - uniradicular teeth or teeth with fused roots) which present ideal conditions to receive dental implants after 3 months.
Who cannot join
- Smoking
- Systemic diseases related with healing disorders
- Poor oral hygiene
- Pregnant or lactating patient
- Use of flap elevation for dental extraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tomographic and Histological Evaluation of Postextraction Sockets Treated With Leucocyte- and Platelet-rich Fibrin: a Randomized Clinical Trial
The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after dental extractions is still a matter of debate. The available literature suggests that L-PRF performs positive effect to improve alveolar preservation resulting in less bone resorption on extraction sockets. L-PRF is a second generation of platelet concentrate produced without biochemical blood manipulation. L-PRF is composed by three key parameters: first, the presence of platelets; second, the presence of leucocytes; third, the density and complex organization of the fibrin matrix architecture produced by a natural polymerization process. The theory is that this key parameters acts to produce a faster bone healing.
- Conditions
- Bone Loss, Alveolar
- Being tested
- Platelet-rich fibrin
- Keywords
- Platelet-rich fibrin, Tooth Extraction, Alveolar Bone Grafting
- 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.
Platelet-rich fibrinProcedure or surgery
Also called platelet concentrate
The use of autologous platelet-rich fibrin after tooth extraction to promote bone healing and alveolar ridge preservation
| Study group | Role | What they receive |
|---|---|---|
| L-PRF group | Experimental | The use of autologous leucocyte- and platelet-rich fibrin in alveolar sockets after dental extraction. Receives: Procedure: Platelet-rich fibrin |
| Control | No intervention | Conventional tooth extraction without any bone substitute. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width resorption 1mm
The ridge width differences between baseline and after three months of healing 1 mm below the crest.
Measured: After 3 months
Secondary outcomes (6)
Width resorption 3mm
The ridge width differences between baseline and after three months of healing 3 mm below the crest.
Measured: After 3 months
Width resorption 5mm
The ridge width differences between baseline and after three months of healing 5 mm below the crest.
Measured: After 3 months
Histological Analysis - fibrous tissue
The percentage of soft (fibrous) tissue
Measured: After 3 months
Histological Analysis - bone cells
Quantity of bone cells (osteoblast, osteoclast and osteocyte)
Measured: After 3 months
Histological Analysis - capillary vessels
Quantity of capillary vessels
Measured: After 3 months
Histological Analysis - new bone formation
The percentage of the newly formed bone
Measured: After 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Loss, AlveolarStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Vitor dos Santos Canellas, DDS MS, Rio de Janeiro State University
- Investigators
- João Canellas, MSc, Principal investigator, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408418
- Sponsor's protocol ID
- 72596717.3.0000.5259
- Acronym
- L-PRF
- Status last verified
- Mar 2019
- First submitted
- 16 Jan 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Canellas JVDS, da Costa RC, Breves RC, de Oliveira GP, Figueredo CMDS, Fischer RG, Thole AA, Medeiros PJD, Ritto FG. Tomographic and histomorphometric evaluation of socket healing after tooth extraction using leukocyte- and platelet-rich fibrin: A randomized, single-blind, controlled clinical trial. J Craniomaxillofac Surg. 2020 Jan;48(1):24-32. doi: 10.1016/j.jcms.2019.11.006. Epub 2019 Nov 29.
PubMed 31810848
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomographic and Histological Evaluation of Postextraction Sockets Treated With Leucocyte- and Platelet-rich Fibrin: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03408418
- Acronym / sponsor ID
- L-PRF / 72596717.3.0000.5259
- Conditions
- Bone Loss, Alveolar
- Keywords
- Platelet-rich fibrin, Tooth Extraction, Alveolar Bone Grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 24 Jan 2018 (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.
The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after dental extractions is still a matter of debate. The available literature suggests that L-PRF performs positive effect to improve alveolar preservation resulting in less bone resorption on extraction sockets. L-PRF is a second generation of platelet concentrate produced without biochemical blood manipulation. L-PRF is composed by three key parameters: first, the presence of platelets; second, the presence of leucocytes; third, the density and complex organization of the fibrin matrix architecture produced by a natural polymerization process. The theory is that this key parameters acts to produce a faster bone healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-PRF group | Experimental | Procedure: Platelet-rich fibrinThe use of autologous leucocyte- and platelet-rich fibrin in alveolar sockets after dental extraction. |
| Control | No intervention | –Conventional tooth extraction without any bone substitute. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- (1) Health patients, American Society of Anesthesiologists (ASA) I or II
- (2) Patients who need to submit tooth extraction (pre-molar, canine and incisor teeth - uniradicular teeth or teeth with fused roots) which present ideal conditions to receive dental implants after 3 months.
Key exclusion criteria (5 listed)
- Smoking
- Systemic diseases related with healing disorders
- Poor oral hygiene
- Pregnant or lactating patient
- Use of flap elevation for dental extraction
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 |
|---|---|---|
| Platelet-rich fibrinAlso: platelet concentrateThe use of autologous platelet-rich fibrin after tooth extraction to promote bone healing and alveolar ridge preservation | Procedure or surgery | L-PRF group |
Primary outcome
Width resorption 1mm
Time frame: After 3 months
The ridge width differences between baseline and after three months of healing 1 mm below the crest.
6 secondary outcomes
Width resorption 3mm
Time frame: After 3 months
Width resorption 5mm
Time frame: After 3 months
Histological Analysis - fibrous tissue
Time frame: After 3 months
Histological Analysis - bone cells
Time frame: After 3 months
Histological Analysis - capillary vessels
Time frame: After 3 months
Histological Analysis - new bone formation
Time frame: After 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 26 Mar 2019.
- Derived from this study: PubMed 31810848Canellas JVDS, da Costa RC, Breves RC, de Oliveira GP, Figueredo CMDS, Fischer RG, Thole AA, Medeiros PJD, Ritto FG. Tomographic and histomorphometric evaluation of socket healing after tooth extraction using leukocyte- and platelet-rich fibrin: A randomized, single-blind, controlled clinical trial. J Craniomaxillofac Surg. 2020 Jan;48(1):24-32. doi: 10.1016/j.jcms.2019.11.006. Epub 2019 Nov 29.
- Individual participant dataSharing planned: No
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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.
João Canellas, MSc principal investigator
Rio de Janeiro State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich fibrin in people with Bone Loss, Alveolar, run by Rio de Janeiro State University at 1 site in Brazil.
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 2 inclusion and 5 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 26 Mar 2019. 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 Brazil. 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?
Width resorption 1mm (time frame: After 3 months). 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 NCT03408418, 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 26 Mar 2019.