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Completed

NCT Number: NCT07352241

Repeated Injections of i-PRF for Decreasing Root Resorption After the Orthodontic Treatment.

Mandibular incisor crowding is a frequent issue that prompts many adults to seek orthodontic treatment. The treatment may enhance patients' quality of life, facilitate dental plaque control, and improve the quality of periodontal tissue. However, this treatment is accompanied by several side effects, including resorption of the apical portion of the teeth. Platelet-rich concentrates, such as injectable platelet-rich fibrin, have been shown to have positive effects on both soft- and hard-tissue healing. They may serve as a beneficial self-derived material to prevent this complication.

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Key information

Conditions

Crowding of Anterior Maxillary Teeth

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

About this study

In recent years, increasing attention has been directed toward biologically driven approaches to modulate tissue responses during orthodontic treatment and minimize adverse effects, such as root resorption. Platelet-rich fibrin (PRF), a second-generation autologous platelet concentrate, has emerged as a promising biomaterial due to its high concentration of platelets, leukocytes, and a fibrin matrix that allows gradual release of multiple growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). However, in 2014, injectable platelet-rich fibrin (I-PRF), which is similar to PRF, was introduced in France by Choukroun, using non-glass tubes and adjusting the centrifugal force. Just like traditional PRF, i-PRF contains high levels of growth factors, stem cells, leukocytes, and cytokines.

These growth factors play a crucial role in angiogenesis, tissue regeneration, modulation of inflammation, and bone remodeling, all of which are central processes in orthodontic tooth movement and periodontal healing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged between 17 and 28 years
  • Class I malocclusion with moderate crowding (4-6 mm) according to Little's Irregularity Index (LII)
  • Normal or inclination for mandibular incisors
  • Complete permanent teeth.

Exclusion criteria

  • Previous orthodontic treatment,
  • Poor oral hygiene,
  • Severe skeletal discrepancy,
  • The presence of coagulation disorders or being under anticoagulant treatment.

Treatment and study plan

4-time i-PRF injection group

Procedure

I-PRF will be injected in 4 sessions at 28-day intervals. The injection will administered submucosally in the buccal region of the lower incisors, using 2 ml of i-PRF per session (0.5 ml per incisor). Orthodontic wires will be sequenced until they reach 0.019×0.025-inch stainless steel.

Saline injection

Procedure

Saline serum will be injected in 4 sessions at 28-day intervals. The injection will be administered submucosally in the buccal region of the lower incisors, using 2 ml of i-PRF per session (0.5 ml per incisor). Orthodontic wires will be sequenced until they reach 0.019×0.025-inch stainless steel.

Primary outcomes

  1. Change in root length

    Time frame: First assessment time: one day before the commencement of treatment. Second assessment time: within one week following the leveling and alignment stage (The stage is expected to finish within 4 to six months after the beginning of treatment)

    Root resorption (i.e., change in root length) will be measured by calculating the difference in the full linear length of each incisor (incisal edge to the apex) between two assessment times (in millimeters) using CBCT images.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Effect of the Injectable Platelet-rich Fibrin on the Orthodontically Induced Apical Root Resorption Following Non-extraction-based Orthodontic Treatment in Adults: A Randomized Controlled Clinical Trial.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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