Platelet-Rich FibrinPhase 3NCT05766618
The Effect of Multiple Injections of (PRF) on The Rate of Canine Retraction
A Phase 3 study testing Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement in people with Platelet-Rich Fibrin and Acceleration, run by Cairo University at 1 site in Egypt.
Trial summary
this clinical trial aims to prove that multiple injections will produce a steady rate of acceleration of orthodontic tooth movement. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet-Rich Fibrin, Acceleration, Orthodontics
- What is being tested?
- Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Oct 2024
- Phase
- Phase 3
- 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 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- adult patient
- Full set of permanent dentition (excluding third molars).
- Good oral hygiene
- protrusion cases that require extraction of premolars (Bimaxillary protrusion or class II div 1)
Who cannot join
- History of previous orthodontic treatment.
- Systemic disease or drugs affecting tooth movement.
- Smokers
- Poor oral health that precludes orthodontic treatment (presence of caries, active white spots, or periodontal diseases)
- Severe crowding cases with ectopic erupted canines
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Vice president of graduate studies of Cairo University
Cairo, Giza Governorate
faculity of dentistry Cairo university, +2023638755 ext. 530, ortho@dentistry.cu.edu.eg
About this study
Official title: The Effect of Multiple Injections of Platelets Rich Fibrin (i-PRF) on The Rate of Canine Retraction A Split-mouth: A Randomized Controlled Trial
this clinical trial aims to prove that multiple injections will produce a steady rate of acceleration of orthodontic tooth movement.
Read the detailed description
Platelet-rich fibrin injection is a second-generation platelet concentrate, prepared from centrifuged blood which is a rich source of platelets, stem cells, and growth factors seven times greater than that released by platelet-rich plasma. It is a simplified procedure with no biochemical manipulation of blood, free from anticoagulants which are known to inhibit wound healing or any gelling agent, and easily usable with a low rate of mistakes during the preparation procedure.
A variety of growth factors are released by PRF such as platelet-derived growth factor (PDGF), transforming growth factor β (TGF-β), and vascular endothelial growth factor (VEGF), which play a crucial role in angiogenesis, collagen synthesis, and bone regeneration.
Treatment with extraction especially in adult patients may take a longer time due to reported increase in bone density and lower bone regenerative rate. Also, the retraction process to close extraction spaces most of the time is accompanied by bone loss and root resorption as reported in the previous studies. i-PRF can accelerate tooth movement, in addition, prevent tooth retraction undesirable side effects.
- Conditions
- Platelet-Rich Fibrin, Acceleration, Orthodontics
- Being tested
- Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement
- Keywords
- injectable platelets rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movementProcedure or surgery
Also called The effect of autologous platelet concentrates on orthodontic tooth movement
Preparatory phase
- Space closure will be done on a 17x25 stainless steel wire
- Both molars will be indirectly anchored to the miniscrew
- Extend closing coil spring of suitable length from the canine hock to the first molar hock for retraction.
- Apply a force of 150gm for each side. The force is measured by a force gauge and activated each visit to keep it constant all over the retraction phase. PRF Injection protocol
- The First injection will be 3 weeks before extraction
- By the end of the fourth week the patients will be referred for pre-intervention records. Upper arch CBCT will be obtained to take preintervention measurements of the alveolar bone.
- At the time of canine retraction patient will receive another injection immediately and an alginate impression will be taken
- follow up every month and injection will be repeated month after month with an observational period of 5 months.
| Study group | Role | What they receive |
|---|---|---|
| injection site | Experimental | it is the arm where the patients will receive the PRF injection intraligamentally in distobuccal, and distopalatal areas of the distal surface of the canine also submucosal injection will be given buccally and palatially (0.25mm) for each side in either the right or left side of the arch. Receives: Procedure: Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement |
| control site | No intervention | it is the arm where the patients will not receive any injection with the same method of retraction as the intervention side. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction.
Rate of orthodontic tooth movement will be measured by calculating the difference in the canine position in mm throughout digital superimposition of consecutive digital models that will be made every four weeks.
Measured: 5 months
Secondary outcomes (1)
1. Assess bone level between intervention and control side.
- bone level between intervention and control side will be assessed through pre and post retraction CBCT for the upper arch.
Measured: bone level will be measured at the beginning of the study (T1) and by the fifth month of the study (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Platelet-Rich FibrinStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a split-mouth randomized, controlled single-center superiority trial, with two parallel groups with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mohamed Elmoghazy Alkhawaga, Cairo University
- Investigators
- Mohamed M Alkhawaga, BDS, Principal investigator, Cairo UniversityFady Fahim, phD, Study director, Cairo UniversitySally Magdy, phD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766618
- Sponsor's protocol ID
- I-PRF in orthodontics
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0.
PubMed 31155698Huang H, Williams RC, Kyrkanides S. Accelerated orthodontic tooth movement: molecular mechanisms. Am J Orthod Dentofacial Orthop. 2014 Nov;146(5):620-32. doi: 10.1016/j.ajodo.2014.07.007. Epub 2014 Oct 28.
PubMed 25439213Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
PubMed 33481053El-Timamy A, El Sharaby F, Eid F, El Dakroury A, Mostafa Y, Shaker O. Effect of platelet-rich plasma on the rate of orthodontic tooth movement. Angle Orthod. 2020 May 1;90(3):354-361. doi: 10.2319/072119-483.1.
PubMed 33378433Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.
PubMed 33459765KINGSLEY CS. Blood coagulation; evidence of an antagonist to factor VI in platelet-rich human plasma. Nature. 1954 Apr 17;173(4407):723-4. doi: 10.1038/173723a0. No abstract available.
PubMed 13165629Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
PubMed 15085519He L, Lin Y, Hu X, Zhang Y, Wu H. A comparative study of platelet-rich fibrin (PRF) and platelet-rich plasma (PRP) on the effect of proliferation and differentiation of rat osteoblasts in vitro. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):707-13. doi: 10.1016/j.tripleo.2009.06.044.
PubMed 19836723Dohan Ehrenfest DM, Del Corso M, Diss A, Mouhyi J, Charrier JB. Three-dimensional architecture and cell composition of a Choukroun's platelet-rich fibrin clot and membrane. J Periodontol. 2010 Apr;81(4):546-55. doi: 10.1902/jop.2009.090531.
PubMed 20373539Dohan 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 16504849Del Corso M, Vervelle A, Simonpieri A, Jimbo R, Inchingolo F, Sammartino G, Dohan Ehrenfest DM. Current knowledge and perspectives for the use of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in oral and maxillofacial surgery part 1: Periodontal and dentoalveolar surgery. Curr Pharm Biotechnol. 2012 Jun;13(7):1207-30. doi: 10.2174/138920112800624391.
PubMed 21740371Reichert C, Kutschera E, Plotz C, Scharf S, Golz L, Fimmers R, Fuhrmann C, Wahl G, Braumann B, Jager A. Incidence and severity of gingival invaginations associated with early versus late initiation of orthodontic space closure after tooth extraction : A multicenter pilot and randomized controlled trial. J Orofac Orthop. 2017 Sep;78(5):415-425. doi: 10.1007/s00056-017-0098-9. Epub 2017 Jun 28.
PubMed 28660421Farshidfar N, Amiri MA, Firoozi P, Hamedani S, Ajami S, Tayebi L. The adjunctive effect of autologous platelet concentrates on orthodontic tooth movement: A systematic review and meta-analysis of current randomized controlled trials. Int Orthod. 2022 Mar;20(1):100596. doi: 10.1016/j.ortho.2021.10.004. Epub 2021 Dec 2.
PubMed 34866025Sivarajan S, Ringgingon LP, Fayed MMS, Wey MC. The effect of micro-osteoperforations on the rate of orthodontic tooth movement: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2020 Mar;157(3):290-304. doi: 10.1016/j.ajodo.2019.10.009.
PubMed 32115107Mheissen S, Khan H, Alsafadi AS, Almuzian M. The effectiveness of surgical adjunctive procedures in the acceleration of orthodontic tooth movement: A systematic review of systematic reviews and meta-analysis. J Orthod. 2021 Jun;48(2):156-171. doi: 10.1177/1465312520988735. Epub 2021 Feb 5.
PubMed 33546565
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multiple Injections of Platelets Rich Fibrin (i-PRF) on The Rate of Canine Retraction A Split-mouth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05766618
- Acronym / sponsor ID
- I-PRF in orthodontics
- Conditions
- Platelet-Rich Fibrin, Acceleration, Orthodontics
- Keywords
- injectable platelets rich fibrin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 13 Mar 2023 (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 clinical trial aims to prove that multiple injections will produce a steady rate of acceleration of orthodontic tooth movement.
Detailed description
Platelet-rich fibrin injection is a second-generation platelet concentrate, prepared from centrifuged blood which is a rich source of platelets, stem cells, and growth factors seven times greater than that released by platelet-rich plasma. It is a simplified procedure with no biochemical manipulation of blood, free from anticoagulants which are known to inhibit wound healing or any gelling agent, and easily usable with a low rate of mistakes during the preparation procedure.
A variety of growth factors are released by PRF such as platelet-derived growth factor (PDGF), transforming growth factor β (TGF-β), and vascular endothelial growth factor (VEGF), which play a crucial role in angiogenesis, collagen synthesis, and bone regeneration.
Treatment with extraction especially in adult patients may take a longer time due to reported increase in bone density and lower bone regenerative rate. Also, the retraction process to close extraction spaces most of the time is accompanied by bone loss and root resorption as reported in the previous studies. i-PRF can accelerate tooth movement, in addition, prevent tooth retraction undesirable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a split-mouth randomized, controlled single-center superiority trial, with two parallel groups with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| injection site | Experimental | Procedure: Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movementit is the arm where the patients will receive the PRF injection intraligamentally in distobuccal, and distopalatal areas of the distal surface of the canine also submucosal injection will be given buccally and palatially (0.25mm) for each side in either the right or left side of the arch. |
| control site | No intervention | –it is the arm where the patients will not receive any injection with the same method of retraction as the intervention side. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- adult patient
- Full set of permanent dentition (excluding third molars).
- Good oral hygiene
- protrusion cases that require extraction of premolars (Bimaxillary protrusion or class II div 1)
Key exclusion criteria (5 listed)
- History of previous orthodontic treatment.
- Systemic disease or drugs affecting tooth movement.
- Smokers
- Poor oral health that precludes orthodontic treatment (presence of caries, active white spots, or periodontal diseases)
- Severe crowding cases with ectopic erupted canines
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 |
|---|---|---|
| Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movementAlso: The effect of autologous platelet concentrates on orthodontic tooth movementPreparatory phase * Space closure will be done on a 17x25 stainless steel wire * Both molars will be indirectly anchored to the miniscrew * Extend closing coil spring of suitable length from the canine hock to the first molar hock for retraction. * Apply a force of 150gm for each side. The force is measured by a force gauge and activated each visit to keep it constant all over the retraction phase. PRF Injection protocol * The First injection will be 3 weeks before extraction * By the end of the fourth week the patients will be referred for pre-intervention records. Upper arch CBCT will be obtained to take preintervention measurements of the alveolar bone. * At the time of canine retraction patient will receive another injection immediately and an alginate impression will be taken * follow up every month and injection will be repeated month after month with an observational period of 5 months. | Procedure or surgery | injection site |
Primary outcome
Rate of canine retraction.
Time frame: 5 months
Rate of orthodontic tooth movement will be measured by calculating the difference in the canine position in mm throughout digital superimposition of consecutive digital models that will be made every four weeks.
1 secondary outcome
1. Assess bone level between intervention and control side.
Time frame: bone level will be measured at the beginning of the study (T1) and by the fifth month of the study (T5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Results publication: PubMed 31155698Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0.
- Results publication: PubMed 25439213Huang H, Williams RC, Kyrkanides S. Accelerated orthodontic tooth movement: molecular mechanisms. Am J Orthod Dentofacial Orthop. 2014 Nov;146(5):620-32. doi: 10.1016/j.ajodo.2014.07.007. Epub 2014 Oct 28.
- Results publication: PubMed 33481053Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
- Results publication: PubMed 33378433El-Timamy A, El Sharaby F, Eid F, El Dakroury A, Mostafa Y, Shaker O. Effect of platelet-rich plasma on the rate of orthodontic tooth movement. Angle Orthod. 2020 May 1;90(3):354-361. doi: 10.2319/072119-483.1.
- Results publication: PubMed 33459765Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.
- Results publication: PubMed 13165629KINGSLEY CS. Blood coagulation; evidence of an antagonist to factor VI in platelet-rich human plasma. Nature. 1954 Apr 17;173(4407):723-4. doi: 10.1038/173723a0. No abstract available.
- Results publication: PubMed 15085519Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
- Results publication: PubMed 19836723He L, Lin Y, Hu X, Zhang Y, Wu H. A comparative study of platelet-rich fibrin (PRF) and platelet-rich plasma (PRP) on the effect of proliferation and differentiation of rat osteoblasts in vitro. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):707-13. doi: 10.1016/j.tripleo.2009.06.044.
- Results publication: PubMed 20373539Dohan Ehrenfest DM, Del Corso M, Diss A, Mouhyi J, Charrier JB. Three-dimensional architecture and cell composition of a Choukroun's platelet-rich fibrin clot and membrane. J Periodontol. 2010 Apr;81(4):546-55. doi: 10.1902/jop.2009.090531.
- Results publication: PubMed 16504849Dohan 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.
- Results publication: PubMed 21740371Del Corso M, Vervelle A, Simonpieri A, Jimbo R, Inchingolo F, Sammartino G, Dohan Ehrenfest DM. Current knowledge and perspectives for the use of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in oral and maxillofacial surgery part 1: Periodontal and dentoalveolar surgery. Curr Pharm Biotechnol. 2012 Jun;13(7):1207-30. doi: 10.2174/138920112800624391.
- Results publication: PubMed 28660421Reichert C, Kutschera E, Plotz C, Scharf S, Golz L, Fimmers R, Fuhrmann C, Wahl G, Braumann B, Jager A. Incidence and severity of gingival invaginations associated with early versus late initiation of orthodontic space closure after tooth extraction : A multicenter pilot and randomized controlled trial. J Orofac Orthop. 2017 Sep;78(5):415-425. doi: 10.1007/s00056-017-0098-9. Epub 2017 Jun 28.
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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.
Mohamed M Alkhawaga, BDS principal investigator
Cairo University
Fady Fahim, phD study director
Cairo University
Sally Magdy, phD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Injectable platelet rich fibrin (i-PRF): in acceleration of orthodontic tooth movement in people with Platelet-Rich Fibrin and Acceleration, run by Cairo University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 13 Mar 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M Alkhawaga, BDS (+201099345694, mohamed.mamdouh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of canine retraction. (time frame: 5 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 NCT05766618, which also lists 31 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 13 Mar 2023.