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

Root Resorption Clinical Trial

Official title:

Assessment of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Root Resorption: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06198322
• Other study ID #: REC-FDBSU/P206042023-03/AR
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2023
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: Beni-Suef University
• Contact: Rehab Khalil
• Phone: 01005230669
• Email: rehababdelrazek[@]dent.bsu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Root Resorption

Intervention

Other:
• Platelet-rich Fibrin
Platelet-rich Fibrin will be injected distal to the canine on the experimental side
• Vitamin D3
Vitamin D3 will be injected distal to the canine on the experimental side

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Beni Suef University	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Assess the effect of using PRF and vitamin D? 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