Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement

Tooth Mobility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302296
• Other study ID #: Hama University/
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: July 15, 2025

Study information

• Verified date: March 2024
• Source: Hama University
• Contact: FADI JNAID, Associate Professor
• Phone: 988499015
• Email: Drfadijnaid[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: July 15, 2025
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Mobility

Intervention

Device:
• injectable form of PRF
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.

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

Locations

Country	Name	City	State
Syrian Arab Republic	Fadi Jnaid	Hama

Sponsors (1)

Lead Sponsor	Collaborator
Hama University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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