The Effect of Autologous Platelet Concentrations on Orthodontic Treatment Time

April 14, 2022 updated by: Damascus University

Comparison Between The Effect of Platelet Rich Plasma (PRP) and Injectable Platelet Rich Fibrin (I-PRF) on Orthodontic Tooth Movement

60 patients needed therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines were divided to randomly three groups:

(1) PRP group: Received PRP injections, (2) I-PRF group: Received I-PRF injections, (3) Control group: conventional treatment with no injections. TPAs were used as an anchor unit. Coil springs were used to distalize the upper canines on 0.019 x 0.025-inch stainless archwires. Alginate impressions and dental casts of the maxillary arch were done at five-time points over a 4-month follow-up period. The amount of canine movement, canine rotation, and anchorage loss were measured on three-dimensional digital models superimposed on the rugae area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One of the most important goals of orthodontic treatment is to decrease the treatment time via achieving faster tooth movement chiefly in adults. Adults have more bone density and less bone turnover than adolescence, which may be linked to potential root resorption, periodontal problems, and white spot lesions.

Approaches to reduce orthodontic treatment time included surgical and non-surgical techniques. Non-surgical approaches such as systemic and local administration of chemical substances, low-level laser therapy, vibrations, and pulsed electrical stimulation therapy still need more studies to determine their safety and effectiveness.

Surgical procedures such as corticotomy, corticision, and micro-osteoperforations have

, in general high success rates, but they rely on incurring an injury to bone tissues. The latter has been linked to the regional acceleratory phenomenon (RAP). But the invasive nature of these procedures, associated risks of loss of alveolar bone and gingival recession, and the help needed from another specialist limit its routine application. Recently, the possibility of using platelet-based preparations from the patient's blood to accelerate orthodontic tooth movement like platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) has grown. PRF represents the second generation of biological materials derived from blood. It is obtained through a centrifuge of the patient's blood without adding any additives to the tube. The variety of growth factors in PRP and PRF may have the ability to stimulate the activation of osteoblasts and osteoclasts together, which supports the idea that PRP could affect orthodontic tooth movement The study sample consisted of 60 patients and was calculated using (G-power sample size calculator), depending on the rate of canine retraction with a study power of 90%.

After ensuring the patient's compliance with the terms and conditions of this study, the purpose and methods of the study were explained to the patients using Information Sheet. In case of approval to participate, the patients were asked to sign the informed consent. Extra & Intra-oral photographs, impressions and clinical examinations were made.

Canine retraction was initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time.

Study Type

Interventional

Enrollment (Actual)

60

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 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

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. both male and female subjects
  2. 18-25 years old
  3. Class II Division 1 malocclusion, treated with extraction of the maxillary first premolars
  4. Full permanent dentition
  5. Good general and oral health

Exclusion Criteria:

  1. extreme skeletal class II malocclusion, overjet > 10 mm ANB>7◦
  2. diseases and medications that were likely to affect bone biology
  3. poor oral hygiene
  4. previous orthodontic treatment
  5. smoking
  6. coagulation disorders, or being treated with anticoagulants

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: The platelet-rich plasma (PRP) group:
The patients in this group received PRP injections immediately before the canine retraction, and after 8 weeks of the onset of retraction
Other: The platelet-rich plasma (PRP)

Twenty ml of venous blood was drawn from each patient with the use of PRP tubes that contain anticoagulant citrate dextrose. The double-spin technique was used to prepare the PRP. The injection areas were anesthetized with lidocaine 2% with epinephrine 1/80000 and left for 10 minutes. 15 units (0. 15 mL) of PRP were injected interaligamentlly in the middle, distobuccal, and distopalatal areas of the distal surface of the upper canines (5 units in each area) together with submucosal injections buccally and palatally (100 units and 50 units

, respectively).
Experimental: The injectable platelet-rich fibrin (I-PRF) group
The patients in this group received I-PRF injections immediately before the canine retraction, and after 8 weeks of the onset of retraction
Other: The injectable platelet-rich fibrin (I-PRF) group

Twenty ml of venous blood was drawn from each patient in this experimental group.

I-PRF was prepared with the use of 20 ml of blood drawn from the patient in dry sterile tubes without anticoagulant (quickly before coagulation starts) by following the centrifugation protocol requires one cycle only (700 RPM for 3 minutes) Injection procedures, sites, and time were similar to the PRP group.
Active Comparator: The control group
The patients in this group did not receive any injections
Device: The control group
NiTi closed-coil springs (American Orthodontics, Sheboygan, WI) were used to impose 150 g force from the first molar band hook to the bracket of canine on each side on 0.019*0.025-in SS archwire Patients' follow-up appointments were two weeks intervals; at each visit, the force produced by the coil was checked and readjusted when needed in order to keep it at 150-g level and the appliances were examined for any deformation or change in the position because of chewing. Canine retraction continued until achieving Class I canine relationship.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in canine retraction rate
Time Frame: The estimation took place at five time points: the beginning of tooth movement (T0) and at 4, 8, 12, and 16 weeks following T0
The amount of canine retraction per month was calculated by measuring the distance from the canine cusp tip in the baseline model to the canine cusp tip in the next superimposed model. The amount of distance being retracted in millimeters was divided to the duration of retraction in months to give an estimation of the retraction rate.
The estimation took place at five time points: the beginning of tooth movement (T0) and at 4, 8, 12, and 16 weeks following T0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the maxillary first molar position (anchorage loss)
Time Frame: T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction
Anchorage loss was calculated in the superimposed digital models from the mesial central fossa of a maxillary first molar of the baseline model the mesial central fossa of maxillary first molar in the next superimposed model.
T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction
Change in canine rotation
Time Frame: T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction
The amount of canine rotation was measured in superimposed digital models. Mesial and distal contact points of the canines were used to make a horizontal line that would make an angle with the similar line in the next superimposed model, this angle referred to the amount of canine rotation between the two superimposed models.
T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction

Collaborators and Investigators

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

Sponsor

Damascus University

Collaborators

Hama University

Investigators

  • Principal Investigator: Ali Ammar, DDS, MSc, Department of orthodontics, Hama University, Syria
  • Study Director: Rabab al-Sabbagh, DDS,MSc,PhD, Department of orthodontics, Hama University, Syria

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)

February 8, 2019

Primary Completion (Actual)

May 12, 2019

Study Completion (Actual)

December 25, 2020

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHDS-Ortho-07-2022

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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