Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on the Periodontal Health

NCT06223477 | Unknown

• 1 other identifier: # REC-FDBSU/P106042023-03/AR
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effect of using PRF and vitamin Dꝫ injections on periodontal health and parameters and compare them when used to facilitate orthodontic treatment.

Conditions

Periodontal Health

Keywords

platelet-rich fibrin; vitamin D3; periodontal health

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of using PRF and Vitamin Dꝫ injections on periodontal health and compare them.

  Clinical periodontal examination of the upper canines will be done before and after retraction on the experimental and control sides by recording the probing depth (PD). • The probing depth will be measured from the gingival margin to the base of the gingival sulcus in millimeters by using a manual periodontal probe (William's probe). The measurements will be recorded at 6 sites around the tooth.

  3 - 4 months

Secondary Outcomes (1)

• Investigate the effect of PRF and Vitamin Dꝫ injections on the gingival thickness.

  3 - 4 months

Other Outcomes (4)

• Evaluate the effect of using PRF and Vitamin Dꝫ injections on the width of keratinized mucosa (KM)

  3 - 4 months

• Evaluate the effect of using PRF and Vitamin Dꝫ injections on the gingival index.

  3 - 4 months

• Evaluate the effect of using PRF and Vitamin Dꝫ injections on the plaque index.

  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 OTHER

PRF will be injected distal to the canine on the experimental side.

Platelet-rich Fibrin

Vitamin D3 OTHER

Vitamin Dꝫ will be 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, 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

• 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

• 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

• Bollen AM, Cunha-Cruz J, Bakko DW, Huang GJ, Hujoel PP. The effects of orthodontic therapy on periodontal health: a systematic review of controlled evidence. J Am Dent Assoc. 2008 Apr;139(4):413-22. doi: 10.14219/jada.archive.2008.0184.

  PMID: 18385025 BACKGROUND

• Faour NH, Dayoub S, Hajeer MY. Evaluation of the Hyaluronic Acid Versus the Injectable Platelet-Rich Fibrin in the Management of the Thin Gingival Phenotype: A Split-Mouth Randomized Controlled Clinical Trial. Cureus. 2022 May 18;14(5):e25104. doi: 10.7759/cureus.25104. eCollection 2022 May.

  PMID: 35607316 BACKGROUND

• 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: 33653326 BACKGROUND

• Lu EM. The role of vitamin D in periodontal health and disease. J Periodontal Res. 2023 Apr;58(2):213-224. doi: 10.1111/jre.13083. Epub 2022 Dec 20.

  PMID: 36537578 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: December 27, 2023
• First Posted: January 25, 2024
• Study Start: May 11, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)