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

NCT07352241 | Completed DMC

• 1 other identifier: UDDS-Ortho-1-2026
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crowding of Anterior Maxillary Teeth

Outcome Measures

Primary Outcomes (1)

• Change in root length

  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)

Study Arms (2)

4-time i-PRF injection group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

Saline serum was injected in the buccal region of the mandibular incisors 4 sessions with 28-day interval

Procedure: Saline injection

Interventions

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.

4-time i-PRF injection group

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.

Control group

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

Location

Related Publications (5)

• Zhang M, McGrath C, Hagg U. The impact of malocclusion and its treatment on quality of life: a literature review. Int J Paediatr Dent. 2006 Nov;16(6):381-7. doi: 10.1111/j.1365-263X.2006.00768.x.

  PMID: 17014535 BACKGROUND

• Valerio CS, Cardoso CAEA, Araujo EA, Zenobio EG, Manzi FR. Bone changes in the mandibular incisors after orthodontic correction of dental crowding without extraction: A cone-beam computed tomographic evaluation. Imaging Sci Dent. 2021 Jun;51(2):155-165. doi: 10.5624/isd.20200260. Epub 2021 Feb 9.

  PMID: 34235061 BACKGROUND

• 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.

  PMID: 33653326 BACKGROUND

• Samandara A, Papageorgiou SN, Ioannidou-Marathiotou I, Kavvadia-Tsatala S, Papadopoulos MA. Evaluation of orthodontically induced external root resorption following orthodontic treatment using cone beam computed tomography (CBCT): a systematic review and meta-analysis. Eur J Orthod. 2019 Jan 23;41(1):67-79. doi: 10.1093/ejo/cjy027.

  PMID: 29771300 BACKGROUND

• Idris MI, Burhan AS, Hajeer MY, Sultan K, Nawaya FR. Efficacy of the injectable platelet-rich fibrin (i-PRF) in gingival phenotype modification: a systematic review and meta-analysis of randomized controlled trials. BMC Oral Health. 2024 Nov 1;24(1):1331. doi: 10.1186/s12903-024-05109-5.

  PMID: 39487452 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mohammad I. Idris, DDS

  Faculty of Dentistry, University of Damascus

  PRINCIPAL INVESTIGATOR

• Ahmad S. Burhan, DDS MSc PhD

  Faculty of Dentistry, University of Damascus

  STUDY DIRECTOR

• Mohammad Y Hajeer, DDS MSc PhD

  Faculty of Dentistry, University of Damascus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: January 13, 2024
• Primary Completion: September 11, 2024
• Study Completion: August 4, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)