Angle Class INCT06562452
Evaluating the Effect of Injectable Platelet Rich Fibrin on Tooth Movement
A study testing Injectable platelet rich fbirin in people with Angle Class I, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Introduction: Prolonged orthodontic treatment can lead to challenges and unfavourable outcomes, including increased risk of caries, root resorption, as well as gingival and periodontal diseases. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Angle Class I
- What is being tested?
- Injectable platelet rich fbirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Aug 2022to 2 Jul 2024
- 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants (age>12 years old) with Class I malocclusion requiring extraction of maxillary first premolar
- No previous orthodontic treatment
- Absence of systemic diseases and dentofacial anomalies
- Participant agreed to participate in the study
Who cannot join
- Participants with periodontal diseases, craniofacial syndromes such as cleft lip or palate, systemic diseases related to bone metabolism
- Taking anticoagulants or medication that interferes with orthodontic tooth movement for example, heparin, warfarin, NSAIDs, cyclosporine, glucocorticoids, medroxyprogesterone acetate, thyroid hormones,
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Prolonged orthodontic treatment can lead to challenges and unfavourable outcomes, including increased risk of caries, root resorption, as well as gingival and periodontal diseases. Acceleration of this step would reduce overall treatment time, improve patient cooperation, and decrease possible negative side effects. The injectable platelet - rich fibrin is second generation holds the advantages of easier preparations and longer effects that is obtained through low-speed centrifugation. The potential benefits of PRF have been widely investigated in regenerative dentistry and oral surgery such as tooth movement, implantology, oral pathology and periodontal therapy.
Objective: Our study aims to investigate the effectiveness of i PRF in accelerating maxillary canine retraction Subjects and method: This study was a split-mouth randomized clinical trial was conducted on 31 patients (9 male, 22 females age ranging 14-31 years) who were treated for Class I malocclusion with the extraction of the maxillary first premolar. After the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization.
Read the detailed description
One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement, acceleration of canine retraction and space closure would reduce overall treatment time. Tooth movement is essentially a biological response to a physical stimulus, speeding up this response should avoid the occurrence of common iatrogenic effects such as white spot lesions, caries, root resorption and periodontal problems 1. Therefore, attempts to accelerate tooth movement and reduce treatment duration are of great significance to both orthodontists and patients. Thus, various invasive and non-invasive modalities have been attempted to reduce the duration of orthodontic treatment by accelerating tooth movement such as: surgical, vibration, pharmacological agents, low-level laser therapy or other procedures 2,3,4,5. However, none of these procedures have yet become a gold standard method. Platelet-based preparations from the patient's blood provide a safe alternative to commercially available bioactive materials. Platelet-rich fibrin (PRF) is the second generation, holds the advantages of easier preparations and longer effects 6-11. The injectable platelet-rich fibrin (i-PRF) was developed as an advanced product of PRF by altering the centrifugation protocol by lowering the centrifugation speed and force to 700 rotations per minute within 3 minutes. has many advantages over the conventional form such as higher rates of leukocyte, regenerative cells and growth factors. The potential benefits of PRF have been widely investigated in regenerative dentistry and oral surgery such as tooth movement, implantology, oral pathology and periodontal therapy 12,13,14. Wang et al. reported that i-PRF affected osteoblastic behavior remarkably by influencing its migration, proliferation, and differentiation. This promotes cellular activity and accelerates bone turnover and healing 11.
The purpose of this study was to investigate the efficiency of i-PRF in accelerating tooth movement.
- Conditions
- Angle Class I
- Being tested
- Injectable platelet rich fbirin
- Keywords
- injectable platelet-rich fibrin, canine retraction, orthodontic tooth movement
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable platelet rich fbirinDiagnostic test
fter the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization.
| Study group | Role | What they receive |
|---|---|---|
| Right sides were randomly allocated to treatments with i-PRF | Experimental | The amount of i-PRF was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control. Receives: Diagnostic Test: Injectable platelet rich fbirin |
| Left sides were randomly allocated to control sides. | Experimental | The placebo was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control. Receives: Diagnostic Test: Injectable platelet rich fbirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this study was to investigate the efficiency of i-PRF in accelerating tooth movement.
Digital models were scanned using the iTero scanner (Align Technology, Inc, USA) assessed by Medit Link software at 5 time points (5 months)
Measured: Our study aims to investigate the effectiveness of i PRF in accelerating maxilary canine retraction at 5 time points (5 months): before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Aug 2022
- Primary completion2 Jun 2024
- Study completion2 Jul 2024
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 Angle Class IStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a split-mouth randomized clinical trial was conducted on 31 patients (9 male, 22 females age ranging 14-31 years) who were treated for Class I malocclusion with the extraction of the maxillary first premolar. After the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562452
- Sponsor's protocol ID
- LeNguyenLamCTUMP
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erdur 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 33459765
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Injectable Platelet Rich Fibrin on Tooth Movement
- ClinicalTrials.gov ID
- NCT06562452
- Acronym / sponsor ID
- LeNguyenLamCTUMP
- Conditions
- Angle Class I
- Keywords
- injectable platelet-rich fibrin, canine retraction, orthodontic tooth movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 20 Aug 2024 (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.
Introduction: Prolonged orthodontic treatment can lead to challenges and unfavourable outcomes, including increased risk of caries, root resorption, as well as gingival and periodontal diseases. Acceleration of this step would reduce overall treatment time, improve patient cooperation, and decrease possible negative side effects. The injectable platelet - rich fibrin is second generation holds the advantages of easier preparations and longer effects that is obtained through low-speed centrifugation. The potential benefits of PRF have been widely investigated in regenerative dentistry and oral surgery such as tooth movement, implantology, oral pathology and periodontal therapy.
Objective: Our study aims to investigate the effectiveness of i PRF in accelerating maxillary canine retraction Subjects and method: This study was a split-mouth randomized clinical trial was conducted on 31 patients (9 male, 22 females age ranging 14-31 years) who were treated for Class I malocclusion with the extraction of the maxillary first premolar. After the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization.
Detailed description
One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement, acceleration of canine retraction and space closure would reduce overall treatment time. Tooth movement is essentially a biological response to a physical stimulus, speeding up this response should avoid the occurrence of common iatrogenic effects such as white spot lesions, caries, root resorption and periodontal problems 1. Therefore, attempts to accelerate tooth movement and reduce treatment duration are of great significance to both orthodontists and patients. Thus, various invasive and non-invasive modalities have been attempted to reduce the duration of orthodontic treatment by accelerating tooth movement such as: surgical, vibration, pharmacological agents, low-level laser therapy or other procedures 2,3,4,5. However, none of these procedures have yet become a gold standard method. Platelet-based preparations from the patient's blood provide a safe alternative to commercially available bioactive materials. Platelet-rich fibrin (PRF) is the second generation, holds the advantages of easier preparations and longer effects 6-11. The injectable platelet-rich fibrin (i-PRF) was developed as an advanced product of PRF by altering the centrifugation protocol by lowering the centrifugation speed and force to 700 rotations per minute within 3 minutes. has many advantages over the conventional form such as higher rates of leukocyte, regenerative cells and growth factors. The potential benefits of PRF have been widely investigated in regenerative dentistry and oral surgery such as tooth movement, implantology, oral pathology and periodontal therapy 12,13,14. Wang et al. reported that i-PRF affected osteoblastic behavior remarkably by influencing its migration, proliferation, and differentiation. This promotes cellular activity and accelerates bone turnover and healing 11.
The purpose of this study was to investigate the efficiency of i-PRF in accelerating tooth movement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was a split-mouth randomized clinical trial was conducted on 31 patients (9 male, 22 females age ranging 14-31 years) who were treated for Class I malocclusion with the extraction of the maxillary first premolar. After the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization.
| Arm | Type | Receives |
|---|---|---|
| Right sides were randomly allocated to treatments with i-PRF | Experimental | Diagnostic Test: Injectable platelet rich fbirinThe amount of i-PRF was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control. |
| Left sides were randomly allocated to control sides. | Experimental | Diagnostic Test: Injectable platelet rich fbirinThe placebo was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participants (age>12 years old) with Class I malocclusion requiring extraction of maxillary first premolar
- No previous orthodontic treatment
- Absence of systemic diseases and dentofacial anomalies
- Participant agreed to participate in the study
Key exclusion criteria (2 listed)
- Participants with periodontal diseases, craniofacial syndromes such as cleft lip or palate, systemic diseases related to bone metabolism
- Taking anticoagulants or medication that interferes with orthodontic tooth movement for example, heparin, warfarin, NSAIDs, cyclosporine, glucocorticoids, medroxyprogesterone acetate, thyroid hormones,
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 fbirinfter the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization. | Diagnostic test | Left sides were randomly allocated to control sides., Right sides were randomly allocated to treatments with i-PRF |
Primary outcome
The purpose of this study was to investigate the efficiency of i-PRF in accelerating tooth movement.
Time frame: Our study aims to investigate the effectiveness of i PRF in accelerating maxilary canine retraction at 5 time points (5 months): before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4)
Digital models were scanned using the iTero scanner (Align Technology, Inc, USA) assessed by Medit Link software at 5 time points (5 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 20 Aug 2024.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable platelet rich fbirin in people with Angle Class I, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 2 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 20 Aug 2024. 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 Vietnam. 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?
The purpose of this study was to investigate the efficiency of i-PRF in accelerating tooth movement. (time frame: Our study aims to investigate the effectiveness of i PRF in accelerating maxilary canine retraction at 5 time points (5 months): before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4)). 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 NCT06562452, 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 20 Aug 2024.