Gingival RecessionNCT03992638
Mechanisms of LPRF Action in the Promotion of Wound Healing and Tissue Regeneration
A study testing leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF and CAF in people with Gingival Recession, run by The European Research Group on Periodontology (ERGOPerio) at 1 site in Hong Kong.
Trial summary
This study evaluates the clinical and biological effects of leucocyte and platelet-rich fibrin (L-PRF) on intraoral wound healing. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF and CAF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2019to 31 Dec 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70
- Non-smokers or former smokers
- Participants must agree to read the "Patient information leaflet and provide a signed a copy of the "Informed Consent", after the study design has been completely explained.
- Presence of bilateral isolated Miller Class I and II gingival recessions in anterior and premolar regions.
- Presence of minimum 2 mm of keratinized gingiva apical to the gingival margin at the selected sites.
Who cannot join
- The patient is medically compromised with history of diabetes mellitus or hepatic or renal disease, or other serious medical conditions or transmittable diseases e.g. Hepatitis B or C or AIDS.
- History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or conditions which would require antibiotic prophylaxis invasive dental procedures.
- Patients undergoing therapies involving the use of antibiotic, anti-inflammatory or anticoagulant drugs during the month prior to the baseline exam.
- History of alcohol use or drug abuse.
- Self-reported pregnancy or lactation.
- Subjects would be considered inappropriate for the trial if they have a history of pre-existing acute or chronic medical or psychiatric illness and laboratory abnormality which may pose to increase the risk of the subjects involved in the trial or administering the investigational product or may interfere with the interpretation of trial results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of LPRF Action in the Promotion of Wound Healing and Tissue Regeneration: A Randomised Controlled Trial
This study evaluates the clinical and biological effects of leucocyte and platelet-rich fibrin (L-PRF) on intraoral wound healing.
Read the detailed description
Gingival recession is characterized by the exposure of root surfaces of the tooth, is attributed to the apical migration of the gingival marginal tissue, and it is a frequently noted clinical feature in all populations. Other than cosmetic problems, a gingival recession can have a causative role in tooth sensitivity, and contribute to difficulties in oral hygiene maintenance or root caries. Moreover, it may worsen with time.
The ultimate goal of surgical root-coverage procedures (Periodontal plastic surgery) is the elimination of the recession defect with minimal probing depths after treatment, along with the ability to restore the natural color and texture of the gingiva (gum). By achieving root coverage, overall improved aesthetics, prevention of non-carious cervical lesions or root caries, and treatment of the resulting root sensitivity should be expected.
Surgical interventions in general, and in particular those aiming to reconstruct tissues lost due to trauma or disease in particular, are biologically dependent on a cascade of unimpaired wound healing mechanisms, including a non-disrupted inflammatory process, vascularization(blood supply) of the wound area, and consequent tissue regeneration. Wound healing has been defined as "the natural response to injury compiling a cascade of complex events orchestrated in a way that many cell types guided by the release of soluble mediators and signals. In a bid to enhance this phase, autologous platelet 'concentrates' were developed, derived from centrifuged blood of patients and applied as surgical adjuncts. Previous studies indicate that leucocyte plasma rich fibrin (LPRF/newest generation of platelet concentrates) preparations significantly modulate wound healing and promote tissue regeneration in a variety of oral surgical procedures. Clinical studies where LPRF is analyzed at the molecular level to quantify the temporal release of growth factors, cytokines, or other biomolecular components are still lacking. Despite the broad application of LPRF in modern dentistry information which integrates clinical and molecular data from in vivo models are essential to elucidate its relevant biological mechanisms. The mechanisms of action are unclear, and the relative role of their different components have not been fully explained. This study will aim to investigate if LPRF can offer superior clinical outcomes and will compare the concentrations and kinetics of wound healing regulators in root coverage procedures with and without local application of LPRF.
- Conditions
- Gingival Recession
- Being tested
- leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF, CAF
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leucocyte and platelet-rich fibrin (L-PRF) in combination with CAFProcedure or surgery
Completing root coverage by coronally advanced flap technique in combination with L-PRF.
CAFProcedure or surgery
Completing root coverage by coronally advanced flap technique alone
| Study group | Role | What they receive |
|---|---|---|
| L-PRF membrane | Experimental | Periodontal plastic surgical procedures (coronally advanced flap, CAF) in combination with a double layer autologous leucocyte and platelet-rich fibrin (L-PRF) membrane. Receives: Procedure: leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF |
| Control | Active comparator | CAF Receives: Procedure: CAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gingival recession depth (GR) from baseline to 6 months
Measured from the CEJ to the apical extension of the gingival margin in mm with the use of Florida probe.
Measured: Baseline, 3 months, and 6 months
Change of probing pocket depth (PPD) from baseline to 6 months
Measured from the gingival margin to base of the gingival sulcus in mm with the use of Florida probe.
Measured: Baseline, 3 months, and 6 months
Change of clinical attachment level (CAL) from baseline to 6 months
Measured from cementoenamel junction (CEJ) to the base of the gingival sulcus in mm with the use of Florida probe.
Measured: Baseline, 3 months, and 6 months
Change of keratinized mucosa width (KMW) from baseline to 6 months
Measured from the gingival margin to the mucogingival line in mm with the use of Florida probe.
Measured: Baseline, 3 months, and 6 months
Change of thickness of keratinised gingiva (GT) from baseline to 6 months
Measured 3 mm apical to the gingival margin in mm measured by superimposition of intraoral digital scanning images.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (1)
Concentration of gingival wound fluid molecules
Concentration changes of the molecules and inflammatory mediators in the wound fluid (WF).
Measured: Baseline, 6 hours, 3 days, and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Sep 2019
- Primary completion30 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies 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
- Model description
- Split-mouth design allowing to assess two types of treatment in the same patient.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)
- Sponsor type
- Research network
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Maurizio Tonetti, The European Research Group on Periodontology (ERGOPerio)
- Investigators
- Maurizio Tonetti, PhD MMSc, Principal investigator, The European Research Group on Periodontology (ERGOPerio)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992638
- Sponsor's protocol ID
- Perio20190614
- Status last verified
- Feb 2023
- First submitted
- 17 Jun 2019
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.
PubMed 19722789Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
PubMed 19186964Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
PubMed 18724847Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
PubMed 19335093Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.
PubMed 21721988Castro AB, Meschi N, Temmerman A, Pinto N, Lambrechts P, Teughels W, Quirynen M. Regenerative potential of leucocyte- and platelet-rich fibrin. Part A: intra-bony defects, furcation defects and periodontal plastic surgery. A systematic review and meta-analysis. J Clin Periodontol. 2017 Jan;44(1):67-82. doi: 10.1111/jcpe.12643. Epub 2016 Nov 24.
PubMed 27783851Chambrone L, Lima LA, Pustiglioni FE, Chambrone LA. Systematic review of periodontal plastic surgery in the treatment of multiple recession-type defects. J Can Dent Assoc. 2009 Apr;75(3):203a-203f.
PubMed 19356319Clauser C, Nieri M, Franceschi D, Pagliaro U, Pini-Prato G. Evidence-based mucogingival therapy. Part 2: Ordinary and individual patient data meta-analyses of surgical treatment of recession using complete root coverage as the outcome variable. J Periodontol. 2003 May;74(5):741-56. doi: 10.1902/jop.2003.74.5.741.
PubMed 12816306Clipet F, Tricot S, Alno N, Massot M, Solhi H, Cathelineau G, Perez F, De Mello G, Pellen-Mussi P. In vitro effects of Choukroun's platelet-rich fibrin conditioned medium on 3 different cell lines implicated in dental implantology. Implant Dent. 2012 Feb;21(1):51-6. doi: 10.1097/ID.0b013e31822b9cb4.
PubMed 21986450Cortellini P, Pini Prato G. Coronally advanced flap and combination therapy for root coverage. Clinical strategies based on scientific evidence and clinical experience. Periodontol 2000. 2012 Jun;59(1):158-84. doi: 10.1111/j.1600-0757.2011.00434.x.
PubMed 22507065Culhaoglu R, Taner L, Guler B. Evaluation of the effect of dose-dependent platelet-rich fibrin membrane on treatment of gingival recession: a randomized, controlled clinical trial. J Appl Oral Sci. 2018 May 14;26:e20170278. doi: 10.1590/1678-7757-2017-0278.
PubMed 29768524Dohan Ehrenfest DM, Andia I, Zumstein MA, Zhang CQ, Pinto NR, Bielecki T. Classification of platelet concentrates (Platelet-Rich Plasma-PRP, Platelet-Rich Fibrin-PRF) for topical and infiltrative use in orthopedic and sports medicine: current consensus, clinical implications and perspectives. Muscles Ligaments Tendons J. 2014 May 8;4(1):3-9. eCollection 2014 Jan.
PubMed 24932440Del Pizzo M, Zucchelli G, Modica F, Villa R, Debernardi C. Coronally advanced flap with or without enamel matrix derivative for root coverage: a 2-year study. J Clin Periodontol. 2005 Nov;32(11):1181-7. doi: 10.1111/j.1600-051X.2005.00831.x.
PubMed 16212581Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.
PubMed 16504849Dos Santos Canellas JV, Ritto FG, Medeiros PJD. Efficacy of Platelet-Rich Fibrin After Mandibular Third Molar Extraction: A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2017 Aug;75(8):1576-1577. doi: 10.1016/j.joms.2017.03.060. Epub 2017 May 15. No abstract available.
PubMed 28521145
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of LPRF Action in the Promotion of Wound Healing and Tissue Regeneration: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03992638
- Acronym / sponsor ID
- Perio20190614
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)Research network
- Collaborators
- The University of Hong Kong
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Jun 2019 (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.
This study evaluates the clinical and biological effects of leucocyte and platelet-rich fibrin (L-PRF) on intraoral wound healing.
Detailed description
Gingival recession is characterized by the exposure of root surfaces of the tooth, is attributed to the apical migration of the gingival marginal tissue, and it is a frequently noted clinical feature in all populations. Other than cosmetic problems, a gingival recession can have a causative role in tooth sensitivity, and contribute to difficulties in oral hygiene maintenance or root caries. Moreover, it may worsen with time.
The ultimate goal of surgical root-coverage procedures (Periodontal plastic surgery) is the elimination of the recession defect with minimal probing depths after treatment, along with the ability to restore the natural color and texture of the gingiva (gum). By achieving root coverage, overall improved aesthetics, prevention of non-carious cervical lesions or root caries, and treatment of the resulting root sensitivity should be expected.
Surgical interventions in general, and in particular those aiming to reconstruct tissues lost due to trauma or disease in particular, are biologically dependent on a cascade of unimpaired wound healing mechanisms, including a non-disrupted inflammatory process, vascularization(blood supply) of the wound area, and consequent tissue regeneration. Wound healing has been defined as "the natural response to injury compiling a cascade of complex events orchestrated in a way that many cell types guided by the release of soluble mediators and signals. In a bid to enhance this phase, autologous platelet 'concentrates' were developed, derived from centrifuged blood of patients and applied as surgical adjuncts. Previous studies indicate that leucocyte plasma rich fibrin (LPRF/newest generation of platelet concentrates) preparations significantly modulate wound healing and promote tissue regeneration in a variety of oral surgical procedures. Clinical studies where LPRF is analyzed at the molecular level to quantify the temporal release of growth factors, cytokines, or other biomolecular components are still lacking. Despite the broad application of LPRF in modern dentistry information which integrates clinical and molecular data from in vivo models are essential to elucidate its relevant biological mechanisms. The mechanisms of action are unclear, and the relative role of their different components have not been fully explained. This study will aim to investigate if LPRF can offer superior clinical outcomes and will compare the concentrations and kinetics of wound healing regulators in root coverage procedures with and without local application of LPRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design allowing to assess two types of treatment in the same patient.
| Arm | Type | Receives |
|---|---|---|
| L-PRF membrane | Experimental | Procedure: leucocyte and platelet-rich fibrin (L-PRF) in combination with CAFPeriodontal plastic surgical procedures (coronally advanced flap, CAF) in combination with a double layer autologous leucocyte and platelet-rich fibrin (L-PRF) membrane. |
| Control | Active comparator | Procedure: CAFCAF |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70
- Non-smokers or former smokers
- Participants must agree to read the "Patient information leaflet and provide a signed a copy of the "Informed Consent", after the study design has been completely explained.
- Presence of bilateral isolated Miller Class I and II gingival recessions in anterior and premolar regions.
- Presence of minimum 2 mm of keratinized gingiva apical to the gingival margin at the selected sites.
Key exclusion criteria (6 listed)
- The patient is medically compromised with history of diabetes mellitus or hepatic or renal disease, or other serious medical conditions or transmittable diseases e.g. Hepatitis B or C or AIDS.
- History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or conditions which would require antibiotic prophylaxis invasive dental procedures.
- Patients undergoing therapies involving the use of antibiotic, anti-inflammatory or anticoagulant drugs during the month prior to the baseline exam.
- History of alcohol use or drug abuse.
- Self-reported pregnancy or lactation.
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 |
|---|---|---|
| leucocyte and platelet-rich fibrin (L-PRF) in combination with CAFCompleting root coverage by coronally advanced flap technique in combination with L-PRF. | Procedure or surgery | L-PRF membrane |
| CAFCompleting root coverage by coronally advanced flap technique alone | Procedure or surgery | Control |
Primary outcome
Change of gingival recession depth (GR) from baseline to 6 months
Time frame: Baseline, 3 months, and 6 months
Measured from the CEJ to the apical extension of the gingival margin in mm with the use of Florida probe.
Change of probing pocket depth (PPD) from baseline to 6 months
Time frame: Baseline, 3 months, and 6 months
Measured from the gingival margin to base of the gingival sulcus in mm with the use of Florida probe.
Change of clinical attachment level (CAL) from baseline to 6 months
Time frame: Baseline, 3 months, and 6 months
Measured from cementoenamel junction (CEJ) to the base of the gingival sulcus in mm with the use of Florida probe.
Change of keratinized mucosa width (KMW) from baseline to 6 months
Time frame: Baseline, 3 months, and 6 months
Measured from the gingival margin to the mucogingival line in mm with the use of Florida probe.
Change of thickness of keratinised gingiva (GT) from baseline to 6 months
Time frame: Baseline, 3 months, and 6 months
Measured 3 mm apical to the gingival margin in mm measured by superimposition of intraoral digital scanning images.
1 secondary outcome
Concentration of gingival wound fluid molecules
Time frame: Baseline, 6 hours, 3 days, and 7 days
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 15 Feb 2023.
- Background: PubMed 19722789Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.
- Background: PubMed 19186964Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
- Background: PubMed 18724847Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
- Background: PubMed 19335093Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
- Background: PubMed 21721988Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.
- Background: PubMed 27783851Castro AB, Meschi N, Temmerman A, Pinto N, Lambrechts P, Teughels W, Quirynen M. Regenerative potential of leucocyte- and platelet-rich fibrin. Part A: intra-bony defects, furcation defects and periodontal plastic surgery. A systematic review and meta-analysis. J Clin Periodontol. 2017 Jan;44(1):67-82. doi: 10.1111/jcpe.12643. Epub 2016 Nov 24.
- Background: PubMed 19356319Chambrone L, Lima LA, Pustiglioni FE, Chambrone LA. Systematic review of periodontal plastic surgery in the treatment of multiple recession-type defects. J Can Dent Assoc. 2009 Apr;75(3):203a-203f.
- Background: PubMed 12816306Clauser C, Nieri M, Franceschi D, Pagliaro U, Pini-Prato G. Evidence-based mucogingival therapy. Part 2: Ordinary and individual patient data meta-analyses of surgical treatment of recession using complete root coverage as the outcome variable. J Periodontol. 2003 May;74(5):741-56. doi: 10.1902/jop.2003.74.5.741.
- Background: PubMed 21986450Clipet F, Tricot S, Alno N, Massot M, Solhi H, Cathelineau G, Perez F, De Mello G, Pellen-Mussi P. In vitro effects of Choukroun's platelet-rich fibrin conditioned medium on 3 different cell lines implicated in dental implantology. Implant Dent. 2012 Feb;21(1):51-6. doi: 10.1097/ID.0b013e31822b9cb4.
- Background: PubMed 22507065Cortellini P, Pini Prato G. Coronally advanced flap and combination therapy for root coverage. Clinical strategies based on scientific evidence and clinical experience. Periodontol 2000. 2012 Jun;59(1):158-84. doi: 10.1111/j.1600-0757.2011.00434.x.
- Background: PubMed 29768524Culhaoglu R, Taner L, Guler B. Evaluation of the effect of dose-dependent platelet-rich fibrin membrane on treatment of gingival recession: a randomized, controlled clinical trial. J Appl Oral Sci. 2018 May 14;26:e20170278. doi: 10.1590/1678-7757-2017-0278.
- Background: PubMed 24932440Dohan Ehrenfest DM, Andia I, Zumstein MA, Zhang CQ, Pinto NR, Bielecki T. Classification of platelet concentrates (Platelet-Rich Plasma-PRP, Platelet-Rich Fibrin-PRF) for topical and infiltrative use in orthopedic and sports medicine: current consensus, clinical implications and perspectives. Muscles Ligaments Tendons J. 2014 May 8;4(1):3-9. eCollection 2014 Jan.
- 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.
Maurizio Tonetti, PhD MMSc principal investigator
The European Research Group on Periodontology (ERGOPerio)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF and CAF in people with Gingival Recession, run by The European Research Group on Periodontology (ERGOPerio) at 1 site in Hong Kong.
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 5 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 15 Feb 2023. 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 Hong Kong. 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?
Change of gingival recession depth (GR) from baseline to 6 months (time frame: Baseline, 3 months, and 6 months). The study lists 5 primary outcomes in all. 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 NCT03992638, which also lists 33 linked publications.
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 15 Feb 2023.