NCT06198322

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 11, 2024

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

December 27, 2023

Last Update Submit

January 9, 2024

Conditions

Keywords

platelet-rich fibrinvitamin D3root resorption

Outcome Measures

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.

    3 - 4 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 will be injected distal to the canine on the experimental side

Platelet-rich Fibrin

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

Vitamin D3

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Beni Suef University

Banī Suwayf, Egypt

RECRUITING

Related Publications (16)

  • 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.

    PMID: 24754797BACKGROUND
  • 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.

    PMID: 33110782BACKGROUND
  • 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.

    PMID: 28339612BACKGROUND
  • 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.

    PMID: 20308200BACKGROUND
  • 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: 36008239BACKGROUND
  • 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: 33459765BACKGROUND
  • 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: 33481053BACKGROUND
  • 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: 32591274BACKGROUND
  • 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.

    PMID: 33653326BACKGROUND
  • 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: 32381845BACKGROUND
  • 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: 35198025BACKGROUND
  • 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: 35241902BACKGROUND
  • 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.

    PMID: 29238379BACKGROUND
  • 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.

    PMID: 36203821BACKGROUND
  • 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.

    PMID: 36250145BACKGROUND
  • 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.

    PMID: 21919826BACKGROUND

MeSH Terms

Conditions

Root Resorption

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Rehab Khalil

    Faculty of Dentistry Beni Suef University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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
Model Details: split-mouth, prospective, single-center, single-blinded, two-arm randomized clinical trial with a 1:1 allocation ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Orthodontics

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 10, 2024

Study Start

May 11, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

January 11, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations