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

January 23, 2024 updated by: Rehab Abd El Razek Abd El Aziz Khalil, Beni-Suef University

Evaluation of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on the Periodontal Health During Canine Distalization: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: Platelet-rich Fibrin
PRF will be injected distal to the canine on the experimental side.
Experimental: 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).
Other: Vitamin D3
Vitamin Dꝫ will be injected distal to the canine on the experimental side

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of using PRF and Vitamin Dꝫ injections on periodontal health and compare them.
Time Frame: 3 - 4 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the effect of PRF and Vitamin Dꝫ injections on the gingival thickness.
Time Frame: 3 - 4 months
The gingival thickness will be recorded using an endodontic file with a stopper, which is placed horizontally, perpendicular to the long axis of the tooth on the labial gingiva.
3 - 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of using PRF and Vitamin Dꝫ injections on the width of keratinized mucosa (KM)
Time Frame: 3 - 4 months
The width of keratinized mucosa (KM) on the facial aspect will be measured in millimeters at the mid-facial aspects from the mucogingival junction to the free gingival margin using a periodontal probe before and after canine retraction.
3 - 4 months
Evaluate the effect of using PRF and Vitamin Dꝫ injections on the gingival index.
Time Frame: 3 - 4 months

The gingival index will be evaluated by the following scores before and after canine retraction:

0: Normal gingival, no inflammation, no discoloration, no bleeding.

  1. Mild inflammation, slight color change, mild alteration of gingival surface, no bleeding.
  2. Moderate inflammation, erythema, swelling, bleeding on probing or when pressure is applied
  3. severe inflammation, severe erythema, swelling, tendency towards spontaneous bleeding some ulceration.
3 - 4 months
Evaluate the effect of using PRF and Vitamin Dꝫ injections on the plaque index.
Time Frame: 3 - 4 months

Plaque index will be evaluated by the following scores before and after canine retraction:

0: No dental plaque

  1. Thin film of plaque at the gingival margin not visible by naked eye and detect by probe
  2. Moderate film of plaque at the gingival margin, interdental space free of plaque visible by naked eye
  3. Heavy plaque accumulation at the gingival margin on interdental space filled with plaque (calculus)
3 - 4 months
Evaluate the effect of using PRF and Vitamin Dꝫ injections on the clinical attachment level (CAL)
Time Frame: 3 - 4 months
Clinical attachment level (CAL) will be measured from the cementoenamel junction to the base of the periodontal pocket in millimeters by using a periodontal probe.
3 - 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Rehab Khalil, Faculty of Dentistry Beni Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Estimated)

January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • # REC-FDBSU/P106042023-03/AR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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