Malocclusion, Angle Class II, Division 1NCT03399760
Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Enhancing Bone Quality
A study testing i-PRF and canine retraction in people with Malocclusion, Angle Class II, Division 1, run by Damascus University at 1 site in Syria.
Trial summary
Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Read more about this study
- Who is it for?
- Ages 15 to 27 years
- Conditions the study is for
- Malocclusion, Angle Class II, Division 1
- What is being tested?
- i-PRF and canine retraction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 20 Aug 2017to 10 Jul 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 15 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult healthy patients, Male and female, Age range: 15-27 years.
- Class II Division 1 malocclusion:
- Mild / moderate skeletal Class II (ANB ≤7)
- Overjet ≤10
- Normal or excessive facial height (Clinically and then cephalometry assessed using these angles : SN-MP , MM , Y axis)
- Mild to moderate crowding ≤ 4
Show all 13Show fewer
- permanent occlusion.
- Exist all the upper teeth (except third molars).
- Good oral and periodontal health:
- Probing depth < 4 mm
- No radiographic evidence of bone loss.
- Gingival index ≤ 1
- Plaque index ≤ 1
Who cannot join
- Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
- patients have anti indication for oral surgery ( medical - social - psycho)
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
- Poor oral hygiene or Current periodontal disease:
- Probing depth ≥ 4 mm
Show all 14Show fewer
- radiographic evidence of bone loss
- Gingival index > 1
- Plaque index > 1
- Patient had previous orthodontic treatment
- Craniofacial anomalies (cleft lip and palate patients)
- Smokers
- coagulation disorders and patients treated with anticoagulants.
- patients with immunodeficiency disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Dento-alveolar Changes After Platelet Rich Fibrin (i-PRF) Injection During Upper Canine Retraction Using Cone-beam Computed Tomography (CBCT)
Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side. Soldered transpalatal arch will be used as an anchor unit. The dento-alveolar changes will be assessed immediately before retraction and after 6 months using CBCT.
Read the detailed description
Extraction is a procedure that is currently performed in orthodontics, either in the context of early treatment or for adolescents with severe crowding or protrusion/overjet. The consequences of this ''simple'' procedure may show up many mucosal and osseous complications such as: bone resorption with collapse of the alveolar process, a gingival cleft or gingival recession in the area surrounding the extraction site. Besides the potential esthetic repercussions, these periodontal defects also give rise to a clinical problem with achieving some orthodontic movements, such as complete closure of the space or uprighting a root.
A systematic review evaluating alveolar bone dimension changes of extraction sockets showed a range of width reduction of 2.6-4.6mm, Two-thirds of the loss occurred in the first 3 months, the remodeling of alveolar bone in the extraction site always decreases ridge volume and deforms the ridge configuration which impairs orthodontic movement of the tooth posteriorly.
Endogenously produced biologicals have been tested based on their roles in the turnover of alveolar bone in response to orthodontic tooth movement as well as during wound healing.
From here it has been thought about using a method to enhance bone quality after extraction. The platelet rich fibrin (PRF) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).
PRF characteristics in comparison to platelet rich plasma PRP are:
- its preparation is completely natural and there is no need for thrombin addition so there isn't immune reaction
- it contains stem cells
- it requires one stage centrifugation
- PRF has been reported to gradually release autologous growth factors and expressed stronger and more durable effect on the cellular proliferation and differentiation than PRP in vitro This is the first study in the world that will use i-PRF with Orthodontic treatment, because of its benefits and easiness of using in dental clinic Study sample that consists of 20 patients, Allocation of the sides of intervention (PRF injection) and control sides is made by computer program (Excel).
After ensuring of the patients compliance with the terms and conditions of this study, the purpose and methods of the study will be explained to the patients using Information Sheet. In case of approval to participate, the patients asked to sign the Informed Consent.
Extra \& Intra-oral photographs, impressions and clinical examination will be made.
Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time 20ml of patients' blood will be withdrawn and centrifuged (700 rpm within 3 minutes) to get 4ml i-PRF. PRF will be injected at the area of the extracted first premolar, The first point place is in the buccal interventional side (supra periosteal injection) and the second point place is in the palatal interventional side(sub periosteal injection). PRF will be injected twice at the beginning and at the middle of the canine retraction.
High resolution CBCT will be taken before the beginning of canine retraction (T0) and after 6 months (T1).
- Conditions
- Malocclusion, Angle Class II, Division 1
- Being tested
- i-PRF, canine retraction
- Keywords
- i-PRF (injectable platelet rich fibrin), alveolar bone height, canine root resorption, bone density, cone-beam computed tomography
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-PRFBiological
i-PRF (injectable platelet rich fibrin) assisted upper canine retraction
canine retractionProcedure or surgery
upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars
| Study group | Role | What they receive |
|---|---|---|
| i-PRF assisted upper canine retraction | Experimental | I-PRF assisted upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars Receives: Biological: i-PRF; Procedure: canine retraction |
| conventional upper canine retraction | Experimental | Conventional upper canine retraction will be performed in the other side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars Receives: Procedure: canine retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canine root resorption
Root length measurement from a reference line between buccal and palatal cemento-enamel junction (CEJ) to apex. These lines are perpendicular to the long axis of the canine. The levels of CEJ and root apex were assessed using a combination of axial, sagittal, and coronal images.
Measured: After 6 months from the beginning of canine retraction
Secondary outcomes (2)
Alveolar bone height in the first premolar region
By measuring the distance between two lines:
The first line: the line passing through the distal and mesial cemento-enamel junction of the canine The second line: the line passing through the crest of the alveolus distal to the canine
Measured: After 6 months from the beginning of canine retraction
Bone density
By using Hounsfield Unites (Gray Values)
Measured: After 6 months from the beginning of canine retraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start20 Aug 2017
- Primary completion20 Jan 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class II, Division 1Studies 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
- Two Arms injectable platelet rich fibrin group: consisted of two subgroups * Experimental group : injectable platelet rich fibrin assisted upper canine retraction * Control group: conventional upper canine retraction
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rania Haddad, PhD., Study director, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399760
- Sponsor's protocol ID
- UDDS-Ortho-01-2018
- Status last verified
- Jul 2019
- First submitted
- 8 Jan 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
Publications
Malmgren O, Goldson L, Hill C, Orwin A, Petrini L, Lundberg M. Root resorption after orthodontic treatment of traumatized teeth. Am J Orthod. 1982 Dec;82(6):487-91. doi: 10.1016/0002-9416(82)90317-7.
PubMed 6961819Lund H, Grondahl K, Grondahl HG. Cone beam computed tomography for assessment of root length and marginal bone level during orthodontic treatment. Angle Orthod. 2010 May;80(3):466-73. doi: 10.2319/072909-427.1.
PubMed 20050738Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
PubMed 19089687Naik B, Karunakar P, Jayadev M, Marshal VR. Role of Platelet rich fibrin in wound healing: A critical review. J Conserv Dent. 2013 Jul;16(4):284-93. doi: 10.4103/0972-0707.114344.
PubMed 23956527Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
PubMed 19929956Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.
PubMed 33653326
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Dento-alveolar Changes After Platelet Rich Fibrin (i-PRF) Injection During Upper Canine Retraction Using Cone-beam Computed Tomography (CBCT)
- ClinicalTrials.gov ID
- NCT03399760
- Acronym / sponsor ID
- UDDS-Ortho-01-2018
- Conditions
- Malocclusion, Angle Class II, Division 1
- Keywords
- i-PRF (injectable platelet rich fibrin), alveolar bone height, canine root resorption, bone density, cone-beam computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 16 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.
Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side. Soldered transpalatal arch will be used as an anchor unit. The dento-alveolar changes will be assessed immediately before retraction and after 6 months using CBCT.
Detailed description
Extraction is a procedure that is currently performed in orthodontics, either in the context of early treatment or for adolescents with severe crowding or protrusion/overjet. The consequences of this ''simple'' procedure may show up many mucosal and osseous complications such as: bone resorption with collapse of the alveolar process, a gingival cleft or gingival recession in the area surrounding the extraction site. Besides the potential esthetic repercussions, these periodontal defects also give rise to a clinical problem with achieving some orthodontic movements, such as complete closure of the space or uprighting a root.
A systematic review evaluating alveolar bone dimension changes of extraction sockets showed a range of width reduction of 2.6-4.6mm, Two-thirds of the loss occurred in the first 3 months, the remodeling of alveolar bone in the extraction site always decreases ridge volume and deforms the ridge configuration which impairs orthodontic movement of the tooth posteriorly.
Endogenously produced biologicals have been tested based on their roles in the turnover of alveolar bone in response to orthodontic tooth movement as well as during wound healing.
From here it has been thought about using a method to enhance bone quality after extraction. The platelet rich fibrin (PRF) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).
PRF characteristics in comparison to platelet rich plasma PRP are:
- its preparation is completely natural and there is no need for thrombin addition so there isn't immune reaction
- it contains stem cells
- it requires one stage centrifugation
- PRF has been reported to gradually release autologous growth factors and expressed stronger and more durable effect on the cellular proliferation and differentiation than PRP in vitro This is the first study in the world that will use i-PRF with Orthodontic treatment, because of its benefits and easiness of using in dental clinic Study sample that consists of 20 patients, Allocation of the sides of intervention (PRF injection) and control sides is made by computer program (Excel).
After ensuring of the patients compliance with the terms and conditions of this study, the purpose and methods of the study will be explained to the patients using Information Sheet. In case of approval to participate, the patients asked to sign the Informed Consent.
Extra \& Intra-oral photographs, impressions and clinical examination will be made.
Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time 20ml of patients' blood will be withdrawn and centrifuged (700 rpm within 3 minutes) to get 4ml i-PRF. PRF will be injected at the area of the extracted first premolar, The first point place is in the buccal interventional side (supra periosteal injection) and the second point place is in the palatal interventional side(sub periosteal injection). PRF will be injected twice at the beginning and at the middle of the canine retraction.
High resolution CBCT will be taken before the beginning of canine retraction (T0) and after 6 months (T1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two Arms injectable platelet rich fibrin group: consisted of two subgroups * Experimental group : injectable platelet rich fibrin assisted upper canine retraction * Control group: conventional upper canine retraction
| Arm | Type | Receives |
|---|---|---|
| i-PRF assisted upper canine retraction | Experimental | Biological: i-PRF, Procedure: canine retractionI-PRF assisted upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars |
| conventional upper canine retraction | Experimental | Procedure: canine retractionConventional upper canine retraction will be performed in the other side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars |
Who may qualify
- Ages
- 15 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Adult healthy patients, Male and female, Age range: 15-27 years.
- Class II Division 1 malocclusion:
- permanent occlusion.
- Exist all the upper teeth (except third molars).
- Good oral and periodontal health:
Key exclusion criteria (14 listed)
- Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
- patients have anti indication for oral surgery ( medical - social - psycho)
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
- Poor oral hygiene or Current periodontal disease:
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 |
|---|---|---|
| i-PRFi-PRF (injectable platelet rich fibrin) assisted upper canine retraction | Biological | i-PRF assisted upper canine retraction |
| canine retractionupper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars | Procedure or surgery | conventional upper canine retraction, i-PRF assisted upper canine retraction |
Primary outcome
Canine root resorption
Time frame: After 6 months from the beginning of canine retraction
Root length measurement from a reference line between buccal and palatal cemento-enamel junction (CEJ) to apex. These lines are perpendicular to the long axis of the canine. The levels of CEJ and root apex were assessed using a combination of axial, sagittal, and coronal images.
2 secondary outcomes
Alveolar bone height in the first premolar region
Time frame: After 6 months from the beginning of canine retraction
Bone density
Time frame: After 6 months from the beginning of canine retraction
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 18 Jul 2019.
- Background: PubMed 6961819Malmgren O, Goldson L, Hill C, Orwin A, Petrini L, Lundberg M. Root resorption after orthodontic treatment of traumatized teeth. Am J Orthod. 1982 Dec;82(6):487-91. doi: 10.1016/0002-9416(82)90317-7.
- Background: PubMed 20050738Lund H, Grondahl K, Grondahl HG. Cone beam computed tomography for assessment of root length and marginal bone level during orthodontic treatment. Angle Orthod. 2010 May;80(3):466-73. doi: 10.2319/072909-427.1.
- Background: PubMed 19089687Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
- Background: PubMed 23956527Naik B, Karunakar P, Jayadev M, Marshal VR. Role of Platelet rich fibrin in wound healing: A critical review. J Conserv Dent. 2013 Jul;16(4):284-93. doi: 10.4103/0972-0707.114344.
- Background: PubMed 19929956Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
- Derived from this study: PubMed 33653326Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.
- Individual participant dataSharing planned: No. The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
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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.
Rania Haddad, PhD. study director
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-PRF and canine retraction in people with Malocclusion, Angle Class II, Division 1, run by Damascus University at 1 site in Syria.
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 13 inclusion and 14 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 18 Jul 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 Syria. 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?
Canine root resorption (time frame: After 6 months from the beginning of canine retraction). 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 NCT03399760, which also lists 6 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 18 Jul 2019.