Clinical trial NCT06223477: Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on the Periodontal Health
Official title: Evaluation of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on the Periodontal Health During Canine Distalization: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Health
Keywords: platelet-rich fibrin
vitamin D3
periodontal health
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split-mouth, prospective, single-center, single-blinded, two-arm randomized clinical trial with a 1:1 allocation ratio.
Primary purpose: TREATMENT

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.

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
* 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.

Eligibility criteria: Inclusion 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.

Primary outcomes:
measure: Evaluate the effect of using PRF and Vitamin Dꝫ injections on periodontal health and compare them.
timeFrame: 3 - 4 months
Secondary outcomes:
measure: Investigate the effect of PRF and Vitamin Dꝫ injections on the gingival thickness.
timeFrame: 3 - 4 months
Other outcomes:
measure: Evaluate the effect of using PRF and Vitamin Dꝫ injections on the width of keratinized mucosa (KM)
timeFrame: 3 - 4 months
measure: Evaluate the effect of using PRF and Vitamin Dꝫ injections on the gingival index.
timeFrame: 3 - 4 months
measure: Evaluate the effect of using PRF and Vitamin Dꝫ injections on the plaque index.
timeFrame: 3 - 4 months
measure: Evaluate the effect of using PRF and Vitamin Dꝫ injections on the clinical attachment level (CAL)
timeFrame: 3 - 4 months
Locations:
city: Banī Suwayf
country: Egypt
facility: Faculty of Dentistry Beni Suef University
Study officials:
affiliation: Faculty of Dentistry Beni Suef University
name: Rehab Khalil
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
citation: 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.
citation: 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.
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.
citation: 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.