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RecruitingNCT06198322Updated Jan 11, 2024

Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Root Resorption

An interventional study of Platelet-rich Fibrin and Vitamin D3 in Root Resorption, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-01-11.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

This study aims to investigate and compare the effect of PRF and vitamin Dꝫ injections on root resorption by using CBCT

Read the detailed description
  • Participants will be recruited from the Faculty of Dentistry, Beni-Suef University. All subjects will be informed of the treatment procedures and will sign a consent form.
  • Subjects will be randomly divided into two groups:

Group 1 (PRF group): upper canine retraction will be facilitated by PRF injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.

Group II (Vitamin Dꝫ group): canine retraction will be facilitated by Vitamin Dꝫ injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.

  • The predicted sample size (n) was a total of (28) cases (i.e. 14 cases per group). Sample size calculation was performed using G*Power version 3.1.9.7
  • Randomization:

Simple randomization will be designed with the aid of a computer-generated schedule with 1:1 allocation ratio. Allocation concealment will be achieved using identical opaque, sealed envelopes. Randomization and allocation concealment will be performed by one of the academic staff who will not be involved in the study and will keep the allocation table away from the operators. The operator will shuffle the sealed envelopes and will ask the patient to pick one envelope at the time of recruitment. In each group, a randomly selected side will act as the experimental side while the contralateral side will serve as the control. Blinding of the operators will not be applicable and so blinding will be limited to the outcome assessment.

  • Methodology: All patients will be treated with a 0.022-inch MBT bracket system. Leveling and alignment phase will be completed until a 0.017 X 0.025'' stainless steel wire will be inserted passively into the bracket slot. Before canine retraction, the subject will be randomly assigned to one of the groups (PRF or Vitamin Dꝫ group). In both groups, canine retraction will be performed with closed Ni-Ti coil springs with a force of 150 g per side that will be adjusted by the use of a force gauge.
02

Conditions studied

  • Root Resorption

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Keywords

  • platelet-rich fibrin
  • vitamin D3
  • root resorption
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

IInclusion criteria:

  1. Age: 18- 40 years old.
  2. 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.
  3. Good to fair oral hygiene.
  4. Normal probing depth.

Exclusion criteria:

  1. Active periodontal disease.
  2. Poor oral hygiene.
  3. Systemic diseases or medications that alter bone metabolism or tooth movement.
  4. Craniofacial anomalies
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Platelet-rich Fibrin

    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

  • Experimental
    Vitamin D3

    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

  • OtherPlatelet-rich Fibrin

    Platelet-rich Fibrin will be injected distal to the canine on the experimental side

  • OtherVitamin D3

    Vitamin D3 will be injected distal to the canine on the experimental side

05

What researchers measure

Primary outcomes

  1. - Assess the effect of using PRF and vitamin Dꝫ injections on root resorption and length and compare them by using CBCT.

    Cone beam computed tomography (CBCT) will be obtained before treatment and after canine retraction to evaluate the severity of root resorption associated with the two techniques.

    Time frame: 3 - 4 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • Nakano T, Hotokezaka H, Hashimoto M, Sirisoontorn I, Arita K, Kurohama T, Darendeliler MA, Yoshida N. Effects of different types of tooth movement and force magnitudes on the amount of tooth movement and root resorption in rats. Angle Orthod. 2014 Nov;84(6):1079-85. doi: 10.2319/121913-929.1. Epub 2014 Apr 22. PubMed 24754797 ↗
  • Kalra S, Gupta P, Tripathi T, Rai P. External apical root resorption in orthodontic patients: molecular and genetic basis. J Family Med Prim Care. 2020 Aug 25;9(8):3872-3882. doi: 10.4103/jfmpc.jfmpc_802_20. eCollection 2020 Aug. PubMed 33110782 ↗
  • Dudic A, Giannopoulou C, Meda P, Montet X, Kiliaridis S. Orthodontically induced cervical root resorption in humans is associated with the amount of tooth movement. Eur J Orthod. 2017 Oct 1;39(5):534-540. doi: 10.1093/ejo/cjw087. PubMed 28339612 ↗
  • Jiang RP, McDonald JP, Fu MK. Root resorption before and after orthodontic treatment: a clinical study of contributory factors. Eur J Orthod. 2010 Dec;32(6):693-7. doi: 10.1093/ejo/cjp165. Epub 2010 Mar 22. PubMed 20308200 ↗
  • 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. PubMed 36008239 ↗
  • 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. PubMed 33459765 ↗
  • 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. PubMed 33481053 ↗
  • 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. PubMed 32591274 ↗
  • 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. PubMed 33653326 ↗
  • 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. PubMed 32381845 ↗
  • 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. PubMed 35198025 ↗
  • 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. PubMed 35241902 ↗
  • Tehranchi A, Sadighnia A, Younessian F, Abdi AH, Shirvani A. Correlation of Vitamin D status and orthodontic-induced external apical root resorption. Dent Res J (Isfahan). 2017 Nov-Dec;14(6):403-411. doi: 10.4103/1735-3327.218565. PubMed 29238379 ↗
  • Azizi F, Karami N, Golshah A, Imani MM, Safari-Faramani R. Effect of Serum Level of Vitamin D on External Apical Root Resorption in Maxillary Anterior Teeth in Patients under Fixed Orthodontic Treatment. Int J Dent. 2022 Sep 27;2022:7942998. doi: 10.1155/2022/7942998. eCollection 2022. PubMed 36203821 ↗
  • Navya S, Prashantha GS, Sabrish S, Roshan MS, Mathew S. Evaluation of the effect of local administration of PRP vs vitamin D3 on the rate of orthodontic tooth movement and the associated external apical root resorption. J Oral Biol Craniofac Res. 2022 Nov-Dec;12(6):879-884. doi: 10.1016/j.jobcr.2022.09.011. Epub 2022 Oct 4. Erratum In: J Oral Biol Craniofac Res. 2024 Jul-Aug;14(4):351-352. doi: 10.1016/j.jobcr.2024.05.008. PubMed 36250145 ↗
  • Lund H, Grondahl K, Hansen K, Grondahl HG. Apical root resorption during orthodontic treatment. A prospective study using cone beam CT. Angle Orthod. 2012 May;82(3):480-7. doi: 10.2319/061311-390.1. Epub 2011 Sep 16. PubMed 21919826 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06198322
Lead sponsor
Beni-Suef University
Responsible party
Rehab Abd El Razek Abd El Aziz Khalil (Lecturer of Orthodontics, Beni-Suef University) — Principal investigator
First posted
Jan 10, 2024
Start date
May 11, 2023
Primary completion
Mar 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Jan 11, 2024

Study contacts

Rehab Khalil
Contact
rehababdelrazek@dent.bsu.edu.eg
01005230669
Walid Salem
Contact
dr.waledsalem@dent.bsu.edu.eg
01032206673
Rehab Khalil
principal investigator · Faculty of Dentistry Beni Suef University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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