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Clinical Trials/NCT06302296
NCT06302296RecruitingNot Applicable

Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement During Leveling and Alignment Stage Study Description

Hama University1 site in 1 country14 target enrollmentStarted: December 20, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
14
Locations
1
Primary Endpoint
Leveling and alignment maxillary incisors

Study Overview

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.

Detailed Description

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. To this end, we set up this Randomized experiment to evaluate the effect of the injectable form of PRF (i-PRF) on OTM, using nonadditive containing i-PRF, which has higher levels of regenerative cells and growth factors compared with other PRF types because of the use of low centrifugation spee. Accordingly, we aimed to evaluate the effect of i-PRF on the rate of maxillary incisors leveling during comprehensive orthodontic treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 26 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • • 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.

Arms & Interventions

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.

Intervention: injectable form of PRF (Device)

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.

Intervention: Placebo injection (Behavioral)

Outcomes

Primary Outcomes

Leveling and alignment maxillary incisors

Time Frame: One month ,two month,six month

\- 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hama University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

FADI JNAID

Syria-Hama University

Hama University

Study Sites (1)

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