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

Beni-Suef University

Status: Enrolling

Conditions: Root Resorption

Treatments: Other: Vitamin D3; Other: Platelet-rich Fibrin

Study type: Interventional

Funder types: Other

Identifiers

NCT06198322

REC-FDBSU/P206042023-03/AR

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Platelet-rich Fibrin

Experimental group

Description:

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).

Treatment:

Other: Platelet-rich Fibrin

Vitamin D3

Experimental group

Description:

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).

Treatment:

Other: Vitamin D3