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

January 11, 2026 updated by: Damascus University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syria
      • Damascus, Syria, DM20 HAJ72
        • Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4-time i-PRF injection group
I-PRF was injected in the buccal region of the mandibular incisors 4 sessions with 28-day interval.
Procedure: 4-time i-PRF injection group
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.
Placebo Comparator: Control group
Saline serum was injected in the buccal region of the mandibular incisors 4 sessions with 28-day interval
Procedure: Saline injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Mohammad I. Idris, DDS, Faculty of Dentistry, University of Damascus
  • Study Director: Ahmad S. Burhan, DDS MSc PhD, Faculty of Dentistry, University of Damascus
  • Study Chair: Mohammad Y Hajeer, DDS MSc PhD, Faculty of Dentistry, University of Damascus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2024

Primary Completion (Actual)

September 11, 2024

Study Completion (Actual)

August 4, 2025

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-1-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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