NCT06302296

Brief Summary

One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

March 4, 2024

Last Update Submit

September 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Leveling and alignment maxillary incisors

    \- Alginate impressions were taken at insertion of the first archwire (0.014-in nickel-titanium) maxillary incisors Leveling and alignment. Leveling and alignment were achieved through the following sequence of archwires: 0.014-in nickel-titanium (NiTi), 0.016 × 0.022-in NiTi, 0.017 × 0.025-in NiTi, 0.019 × 0.025-in stainless steel (SS)(3).

    One month ,two month,six month

Study Arms (2)

injectable form of PRF

EXPERIMENTAL

A group of patients in which participants will be undergo to orthodontic treatment will be received a 0.9 ml injection of PRF after 1st premolar extraction.

Device: injectable form of PRF

traditional orthodontic treatment

EXPERIMENTAL

A group of patients in which participants will be undergo to traditional orthodontic treatment will be received a Placebo injection after 1st premolar extraction.

Behavioral: Placebo injection

Interventions

A group of patients in which participants will be undergo to orthodontic treatment will be received a 0.9 ml injection of PRF after 1st premolar extraction.

injectable form of PRF

A group of patients in which participants will be undergo to traditional orthodontic treatment will be received a Placebo injection after 1st premolar extraction.

traditional orthodontic treatment

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patient's age (18-26). Severe or very severe irregularity of the upper incisors greater than (7 mm) according to Little's index, so it is recommended to extract the upper first premolar.
  • Class I or Class II malocclusion, first model according to Angle, with skeletal class I or II and a normal or mild vertical growth pattern.
  • All permanent upper teeth, up to the first molar, are present, with the possibility of attaching brackets to all teeth in a correct position.
  • The patient has good oral health.

You may not qualify if:

  • The presence of any systemic disease that affects orthodontic dental movement.
  • Severe malalignment of one of the teeth (palatal quadrant, ectopic canine, ectopic premolar).
  • The patient has undergone previous orthodontic treatment.
  • The patient is subject to any drug treatment that may affect orthodontic dental movement (cortisone, non-steroidal anti-inflammatory drugs).
  • The patient has poor oral health.
  • Commitment to periodic follow-up appointments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fadi Jnaid

Hama, Syria

RECRUITING

MeSH Terms

Conditions

Tooth Mobility

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Eisa Salami, MSc student

    Hama University

    PRINCIPAL INVESTIGATOR
  • Rabab Alsabbagh, Professor

    Hama University

    STUDY CHAIR

Central Study Contacts

FADI JNAID, Associate Professor

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
Syria-Hama University

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 8, 2024

Study Start

December 20, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations