Assessment of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Root Resorption: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Beni-Suef University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- - Assess the effect of using PRF and vitamin Dꝫ injections on root resorption and length and compare them by using CBCT.
Study Overview
Brief Summary
This study aims to investigate and compare the effect of PRF and vitamin Dꝫ injections on root resorption by using CBCT
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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Single-blinded limited to the outcome assessment
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •IInclusion criteria:
- •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.
Exclusion Criteria
- •Active periodontal disease.
- •Poor oral hygiene.
- •Systemic diseases or medications that alter bone metabolism or tooth movement.
- •Craniofacial anomalies
Arms & Interventions
Vitamin D3
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).
Intervention: Vitamin D3 (Other)
Platelet-rich Fibrin
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).
Intervention: Platelet-rich Fibrin (Other)
Outcomes
Primary Outcomes
- Assess the effect of using PRF and vitamin Dꝫ injections on root resorption and length and compare them by using CBCT.
Time Frame: 3 - 4 months
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Rehab Abd El Razek Abd El Aziz Khalil
Lecturer of Orthodontics
Beni-Suef University