The Effect of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Canine Retraction

NCT06071455 | Unknown

• 1 other identifier: # REC-FDBSU/06042023-03/AR
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this study is to assess and compare the effect of PRF and vitamin Dꝫ injection on the rate of canine retraction and to determine the bone thickness changes correlated with the two techniques.

Conditions

Acceleration of Tooth Movement

Keywords

Platelet-rich Fibrin; Vitamin D3; Canine retraction

Outcome Measures

Primary Outcomes (1)

• evaluate the rate of upper canine retraction in the PRF (platelet-rich fibrin) and Vitamin Dꝫ groups and compare between them.

  alginate impressions will be taken just before canine retraction and at a monthly rate till the end of the canine retraction phase. Study casts will be obtained, and the rate of canine movement will be measured every month.

  3 - 4 months

Secondary Outcomes (1)

• investigate the bone thickness changes associated with the two injection techniques and compare between them after canine retraction.

  6 months

Study Arms (2)

Platelet-rich Fibrin

EXPERIMENTAL

A 20 ml blood sample will be drawn from the median cubital vein into a PRF tube. Centrifugation will be done at 700 rpm for 3 minutes and the liquid of PRF will be suctioned out using a separate syringe. PRF will be injected distal to the canine on the experimental side three times; at the beginning of canine retraction (T0), 1 month after the start of canine retraction (T1), and 2 months after the start of canine retraction (T2).

Other: Platelet-rich fibrin

Vitamin D3

EXPERIMENTAL

Subjects will receive vitamin Dꝫ injection distal to the canine on the experimental side three times; at the beginning of canine retraction (T0), 1 month after the start of canine retraction (T1), and 2 months after the start of canine retraction (T2).

Other: Vitamin D3

Interventions

Platelet-rich fibrin OTHER

injected distal to the canine on the experimental side.

Platelet-rich Fibrin

Vitamin D3 OTHER

injected distal to the canine on the experimental side.

Vitamin D3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18- 40 years old.
• Angle Class I or Class II dental malocclusion that required bilateral maxillary first premolar extraction and upper canine retraction as a part of the treatment plan.
• Good to fair oral hygiene.
• Normal probing depth.

You may not qualify if:

• Active periodontal disease.
• Poor oral hygiene.
• Systemic diseases or medications that alter bone metabolism or tooth movement.
• Craniofacial anomalies.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Faculty of Dentistry Beni Suef University

Banī Suwayf, Beni Suef Governorate, Egypt

RECRUITING

Related Publications (8)

• Gupta P, Bhagyalakshmi A, Avinash BS, Prashant A, Raghunath N. Evaluation of injectable platelet-rich fibrin effect on the rate of canine retraction and alkaline phosphatase levels: An in-vivo study. Am J Orthod Dentofacial Orthop. 2022 Nov;162(5):735-743. doi: 10.1016/j.ajodo.2021.07.019. Epub 2022 Aug 23.

  PMID: 36008239 BACKGROUND

• Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.

  PMID: 33459765 BACKGROUND

• Cagli Karci I, Baka ZM. Assessment of the effects of local platelet-rich fibrin injection and piezocision on orthodontic tooth movement during canine distalization. Am J Orthod Dentofacial Orthop. 2021 Jul;160(1):29-40. doi: 10.1016/j.ajodo.2020.03.029. Epub 2021 May 4.

  PMID: 33962809 BACKGROUND

• Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.

  PMID: 33481053 BACKGROUND

• Reyes Pacheco AA, Collins JR, Contreras N, Lantigua A, Pithon MM, Tanaka OM. Distalization rate of maxillary canines in an alveolus filled with leukocyte-platelet-rich fibrin in adults: A randomized controlled clinical split-mouth trial. Am J Orthod Dentofacial Orthop. 2020 Aug;158(2):182-191. doi: 10.1016/j.ajodo.2020.03.020. Epub 2020 Jun 24.

  PMID: 32591274 BACKGROUND

• Varughese ST, Shamanna PU, Goyal N, Thomas BS, Lakshmanan L, Pulikkottil VJ, Ahmed MG. Effect of Vitamin D on Canine Distalization and Alveolar Bone Density Using Multi-slice Spiral CT: A Randomized Controlled Trial. J Contemp Dent Pract. 2019 Dec 1;20(12):1430-1435.

  PMID: 32381845 BACKGROUND

• Al-Attar A, Abid M. The Effect of Vitamin D3 on the Alignment of Mandibular Anterior Teeth: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Feb 14;2022:6555883. doi: 10.1155/2022/6555883. eCollection 2022.

  PMID: 35198025 BACKGROUND

• Khalaf RM, Almudhi AA. Effects of vitamin D deficiency on the rate of orthodontic tooth movement: An animal study. Saudi Dent J. 2022 Feb;34(2):129-135. doi: 10.1016/j.sdentj.2021.12.008. Epub 2021 Dec 23.

  PMID: 35241902 BACKGROUND

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Rehab Khalil

  Faculty of Dentistry, Beni Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rehab Khalil

CONTACT

01005230669; rehababdelrazek@dent.bsu.edu.eg

Maha AbdelKawy

CONTACT

01005276754; maha_abdelkawy@dent.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single-blinded limited to the outcome assessment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Orthodontics

Model Details: split-mouth, prospective, single-center, single-blinded, two-arm randomized clinical trial with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 6, 2023
• Study Start: May 11, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)