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CompletedNCT06562452Updated Aug 20, 2024

Evaluating the Effect of Injectable Platelet Rich Fibrin on Tooth Movement

An interventional study of Injectable platelet rich fbirin in Angle Class I, sponsored by Can Tho University of Medicine and Pharmacy. Completed at 1 site in Vietnam. Open to participants aged 12 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Can Tho University of Medicine and Pharmacy · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Aug 2022, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
12 Years to 35 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Angle Class I

Keywords

  • injectable platelet-rich fibrin
  • canine retraction
  • orthodontic tooth movement
03

In context

Malocclusion, Angle Class I

35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.

This study's enrollment of 31 is close to the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.

Browse Malocclusion, Angle Class I studies →

Lead sponsor

Can Tho University of Medicine and Pharmacy is the lead sponsor of 35 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria:

  • 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, , medroxyprogesterone acetate, thyroid hormones,
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Right sides were randomly allocated to treatments with i-PRF

    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.

    Diagnostic Test: Injectable platelet rich fbirin

  • Experimental
    Left sides were randomly allocated to control sides.

    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.

    Diagnostic Test: Injectable platelet rich fbirin

Interventions

  • Diagnostic testInjectable platelet rich fbirin

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    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)

07

Study locations

1 site
  • Can Tho University of Medicine and Pharmacy
    Cần Thơ, 900000, Vietnam
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2022 to primary completion in Jun 2024, 21 months.

Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's 21 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2024
First posted
Aug 20, 2024
StartActual
Aug 15, 2022
Primary completionActual
Jun 2, 2024
CompletionActual
Jul 2, 2024
Last update
Aug 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06562452
Lead sponsor
Can Tho University of Medicine and Pharmacy
Responsible party
Sponsor
First posted
Aug 20, 2024
Start date
Aug 15, 2022
Primary completion
Jun 2, 2024
Completion
Jul 2, 2024
Last update
Aug 20, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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