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The Effect of Autologous Platelet Concentrations on Orthodontic Treatment Time

Primary Purpose

Class II Division 1 Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
The platelet-rich plasma (PRP)
The injectable platelet-rich fibrin (I-PRF) group
The control group
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Division 1 Malocclusion focused on measuring Platelet-rich plasma, Platelet-rich fibrin, Acceleration

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

The platelet-rich plasma (PRP) group:

The injectable platelet-rich fibrin (I-PRF) group

The control group

Arm Description

The patients in this group received PRP injections immediately before the canine retraction, and after 8 weeks of the onset of retraction

The patients in this group received I-PRF injections immediately before the canine retraction, and after 8 weeks of the onset of retraction

The patients in this group did not receive any injections

Outcomes

Primary Outcome Measures

Change in canine retraction rate
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.

Secondary Outcome Measures

Change in the maxillary first molar position (anchorage loss)
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.
Change in canine rotation
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.

Full Information

First Posted
April 8, 2022
Last Updated
April 14, 2022
Sponsor
Damascus University
Collaborators
Hama University
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1. Study Identification

Unique Protocol Identification Number
NCT05335824
Brief Title
The Effect of Autologous Platelet Concentrations on Orthodontic Treatment Time
Official Title
Comparison Between The Effect of Platelet Rich Plasma (PRP) and Injectable Platelet Rich Fibrin (I-PRF) on Orthodontic Tooth Movement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
May 12, 2019 (Actual)
Study Completion Date
December 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
Collaborators
Hama University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
Keywords
Platelet-rich plasma, Platelet-rich fibrin, Acceleration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The platelet-rich plasma (PRP) group:
Arm Type
Experimental
Arm Description
The patients in this group received PRP injections immediately before the canine retraction, and after 8 weeks of the onset of retraction
Arm Title
The injectable platelet-rich fibrin (I-PRF) group
Arm Type
Experimental
Arm Description
The patients in this group received I-PRF injections immediately before the canine retraction, and after 8 weeks of the onset of retraction
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
The patients in this group did not receive any injections
Intervention Type
Other
Intervention Name(s)
The platelet-rich plasma (PRP)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
The injectable platelet-rich fibrin (I-PRF) group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
The control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in canine retraction rate
Description
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.
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
Secondary Outcome Measure Information:
Title
Change in the maxillary first molar position (anchorage loss)
Description
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.
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
Title
Change in canine rotation
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: both male and female subjects 18-25 years old Class II Division 1 malocclusion, treated with extraction of the maxillary first premolars Full permanent dentition Good general and oral health Exclusion Criteria: extreme skeletal class II malocclusion, overjet > 10 mm ANB>7◦ diseases and medications that were likely to affect bone biology poor oral hygiene previous orthodontic treatment smoking coagulation disorders, or being treated with anticoagulants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ammar, DDS, MSc
Organizational Affiliation
Department of orthodontics, Hama University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rabab al-Sabbagh, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Hama University, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28414871
Citation
Rashid A, ElSharaby FA, Nassef EM, Mehanni S, Mostafa YA. Effect of platelet-rich plasma on orthodontic tooth movement in dogs. Orthod Craniofac Res. 2017 May;20(2):102-110. doi: 10.1111/ocr.12146.
Results Reference
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PubMed Identifier
30147398
Citation
Tehranchi A, Behnia H, Pourdanesh F, Behnia P, Pinto N, Younessian F. The effect of autologous leukocyte platelet rich fibrin on the rate of orthodontic tooth movement: A prospective randomized clinical trial. Eur J Dent. 2018 Jul-Sep;12(3):350-357. doi: 10.4103/ejd.ejd_424_17.
Results Reference
background
PubMed Identifier
32591274
Citation
Reyes Pacheco AA, Collins JR, Contreras N, Lantigua A, Pithon MM, Tanaka OM. Distalization rate of maxillary canines in an alveolus filled with leukocyte-platelet-rich fibrin in adults: A randomized controlled clinical split-mouth trial. Am J Orthod Dentofacial Orthop. 2020 Aug;158(2):182-191. doi: 10.1016/j.ajodo.2020.03.020. Epub 2020 Jun 24.
Results Reference
background
PubMed Identifier
33481053
Citation
Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
Results Reference
background
PubMed Identifier
31662844
Citation
Ali Mahmood TM, Chawshli OF. The Effect of Submucosal Injection of Plasma-Rich Platelets on Blood Inflammatory Markers for Patients with Bimaxillary Protrusion Undergoing Orthodontic Treatment. Int J Inflam. 2019 Oct 1;2019:6715871. doi: 10.1155/2019/6715871. eCollection 2019.
Results Reference
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PubMed Identifier
11907307
Citation
Dixon V, Read MJ, O'Brien KD, Worthington HV, Mandall NA. A randomized clinical trial to compare three methods of orthodontic space closure. J Orthod. 2002 Mar;29(1):31-6. doi: 10.1093/ortho/29.1.31.
Results Reference
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The Effect of Autologous Platelet Concentrations on Orthodontic Treatment Time

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