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

B

Beni-Suef University

Status

Enrolling

Conditions

Periodontal Health

Treatments

Other: Vitamin D3
Other: Platelet-rich Fibrin

Study type

Interventional

Funder types

Other

Identifiers

NCT06223477
# REC-FDBSU/P106042023-03/AR

Details and patient eligibility

About

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.

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 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 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

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

Trial contacts and locations

1

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Central trial contact

Rehab Khalil; Maha Abdelkawy

Data sourced from clinicaltrials.gov

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