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CompletedNCT06634888Updated Oct 10, 2024

Root Resorption and Alveolar Bone in the Maxillary Canine Retraction Using Injectable Platelet-rich Fibrin: A Split-Mouth Trial

An interventional study of Injectable platelet rich fbirin and 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 15 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-10.

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

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Aug 2022, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
15 Years to 25 Years
Sex
All
01

Study summary

Prolonged orthodontic treatment is a risk factor for root resorption, so accelerating the speed of tooth movement using different methods can limit tooth root resorption. There are multiple factors causing root resorption, such as orthodontic force level, treatment duration, and methods of quantification of root resorption. PRF, a completely autologous fibrin matrix, was developed as a second-generation platelet concentrate without adding anticoagulants and additives. The injectable platelet-rich fibrin is the liquid form of the substance obtained through low-speed centrifugation. It has many advantages over the conventional form, such as higher rates of regenerative cells and growth factors. In the present study, Cone Beam Computed Tomography (CBCT) was used as a measurement tool for root resorption. CBCT is a helpful tool for evaluating changes in the root length of teeth and surrounding bone tissue.

Read the detailed description

Orthodontic treatment encompasses not only the correction of malocclusion and enhancement of dental arch aesthetics but also the preservation or restoration of optimal function and periodontal tissue health. Orthodontic tooth movement (OTM) is stimulated by remodeling the periodontal ligament (PDL) and alveolar bone. Bone remodeling is a process of both bone resorption on the pressure side and bone formation on the tension site.

Prolonged orthodontic treatment is a risk factor for root resorption, so accelerating the speed of tooth movement using different methods can limit tooth root resorption. Root resorption is an undesirable effect that occurs during orthodontic treatment. It is defined as a reduction of root length or cringe. Because root resorption is a multifactorial issue, it is essential to know and focus on the controlling factors that cause root resorption. Therefore, attempts to accelerate tooth movement and reduce treatment duration are significant to orthodontists and patients. Adequate alveolar bone volume and root length are prerequisite conditions for successful orthodontic tooth movement and post-treatment stability orthodontic tooth movement causes the inflammatory process in the periodontium to occur.

Platelet-based preparations from the patient's blood provide a safe alternative to commercially available bioactive materials. PRF, a completely autologous fibrin matrix, was developed as a second-generation platelet concentrate without adding anticoagulants and additives. The injectable platelet-rich fibrin (i-PRF) is the liquid form of the substance that is obtained through low-speed centrifugation (700rpm in 3 minutes) and has many advantages over the conventional form, such as higher rates of regenerative cells and growth factors such as prostaglandins, interleukins, the tumor necrosis factor-a superfamily, and receptor activator of nuclear factor (RANK)/RANK ligand (RANKL)/osteoprotegerin (OPG) are increased in the PDL during orthodontic tooth movement . The presence of these inflammatory mediators in the PDL during orthodontic tooth movement indicates their role in the occurrence of orthodontically induced tooth root resorption.

Cone beam computed tomography (CBCT) imaging allows for a three-dimensional evaluation of teeth and their adjacent anatomical structures, resulting in a detailed visualization of the tooth and its neighboring structures. Subsequently, the area of the tooth resorption can be detected easily. CBCT imaging allows radiation to be focused on the area of anatomical interest while encompassing all hard and soft tissues in three dimensions, providing more significant information with a potential decrease in cumulative radiation exposure for patients.

Little is known about the effects of the placement of these biomaterials on the root length of the moved tooth and on the surrounding supporting bone tissue during orthodontic movement. This study aimed to evaluate and compare these effects after distalization of maxillary canines in alveolar preserved with i-PRF and control alveolar in adult patients using Cone beam computed tomography (CBCT).

02

Conditions studied

  • Angle Class I

Keywords

  • injectable platelet-rich fibrin
  • canine retraction
  • root resorption
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
15 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Patients who have completed long-term tooth replacement have cervical vertebral maturity at stages CS5, CS6 according to the classification of Baccetti et al.
  • Patients with type I Angle malformation have bilateral maxillary first small canines
  • No missing teeth except third molars
  • No previous orthodontic treatment
  • Absence of systemic diseases and dentofacial anomalies, had good periodontal health, had typical values of blood tests, e.g., bleeding time 1 - 4 minutes, coagulation time 5 - 10 minutes
  • Patients agreed to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients suffering from bleeding disorders, diabetes, bone diseases, periodontal disease, and cancer are using drugs such as aspirin, heparin, warfarin, non-steroidal anti-inflammatory drugs, and ... affects the speed of tooth movement and the ability to clot and stop bleeding.
  • The patient has trauma and facial deformities
  • The patient smokes and is pregnant. The patient had other teeth extracted except the first premolar
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

  • Placebo comparator
    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

    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. All patients in this study were submitted for Cone beam computed tomography (CBCT) scanning before and after canine retraction. Cone beam computed tomography (CBCT) was used before and four months after retraction, with imaging conducted using the Orthophos SL 3D X-ray machine (Dentsply Sirona, Charlotte, CA, USA) while adhering to As Low As Reasonably Achievable (ALARA) guidelines to minimize radiation exposure

  • Diagnostic testInjectable platelet rich fbirin

    All patients in this study were submitted for Cone beam computed tomography (CBCT) scanning before and after canine retraction. Cone beam computed tomography (CBCT) was used before and four months after retraction, with imaging conducted using the Orthophos SL 3D X-ray machine (Dentsply Sirona, Charlotte, CA, USA) while adhering to As Low As Reasonably Achievable (ALARA) guidelines to minimize radiation exposure

06

What researchers measure

Primary outcomes

  1. Our study aims to investigate the effectiveness of i-PRF in root resorption

    CBCT was used before (T0) and four months (T4) after retraction, with imaging conducted using On Demand 3D software according to the As Low As Reasonably Achievable guidelines.

    Time frame: Our study aims to investigate the effectiveness of i-PRF in root resorption using On Demand 3D software at the time before and 4 months after canine distalization (T0) & (T4)

Secondary outcomes

  1. Our study aims to investigate the effectiveness of i-PRF in alveolar bone density.

    CBCT was used before (T0) and four months (T4) after retraction, with imaging conducted using On Demand 3D software according to the As Low As Reasonably Achievable guidelines.

    Time frame: Our study aims to investigate the effectiveness of i-PRF in alveolar bone density using On Demand 3D software at the time before and 4 months after canine distalization (T0) & (T4)

07

Study locations

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

References and documents

Publications

  • Zeitounlouian 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06634888
Lead sponsor
Can Tho University of Medicine and Pharmacy
Responsible party
Sponsor
First posted
Oct 10, 2024
Start date
Aug 27, 2022
Primary completion
May 27, 2024
Completion
May 27, 2024
Last update
Oct 10, 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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