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Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Enhancing Bone Quality

Primary Purpose

Malocclusion, Angle Class II, Division 1

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
i-PRF
canine retraction
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II, Division 1 focused on measuring i-PRF (injectable platelet rich fibrin), alveolar bone height, canine root resorption, bone density, cone-beam computed tomography

Eligibility Criteria

15 Years - 27 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult healthy patients, Male and female, Age range: 15-27 years.
  2. Class II Division 1 malocclusion:

    • Mild / moderate skeletal Class II (ANB ≤7)
    • Overjet ≤10
    • Normal or excessive facial height (Clinically and then cephalometry assessed using these angles : SN-MP , MM , Y axis)
    • Mild to moderate crowding ≤ 4
  3. permanent occlusion.
  4. Exist all the upper teeth (except third molars).
  5. Good oral and periodontal health:

    • Probing depth < 4 mm
    • No radiographic evidence of bone loss.
    • Gingival index ≤ 1
    • Plaque index ≤ 1

Exclusion Criteria:

  1. Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
  2. patients have anti indication for oral surgery ( medical - social - psycho)
  3. Presence of primary teeth in the maxillary arch
  4. Missing permanent maxillary teeth (except third molars).
  5. Poor oral hygiene or Current periodontal disease:

    • Probing depth ≥ 4 mm
    • radiographic evidence of bone loss
    • Gingival index > 1
    • Plaque index > 1
  6. Patient had previous orthodontic treatment
  7. Craniofacial anomalies (cleft lip and palate patients)
  8. Smokers
  9. coagulation disorders and patients treated with anticoagulants.
  10. patients with immunodeficiency disorders

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

i-PRF assisted upper canine retraction

conventional upper canine retraction

Arm Description

I-PRF assisted upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars

Conventional upper canine retraction will be performed in the other side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars

Outcomes

Primary Outcome Measures

Canine root resorption
Root length measurement from a reference line between buccal and palatal cemento-enamel junction (CEJ) to apex. These lines are perpendicular to the long axis of the canine. The levels of CEJ and root apex were assessed using a combination of axial, sagittal, and coronal images.

Secondary Outcome Measures

Alveolar bone height in the first premolar region
By measuring the distance between two lines: The first line: the line passing through the distal and mesial cemento-enamel junction of the canine The second line: the line passing through the crest of the alveolus distal to the canine
Bone density
By using Hounsfield Unites (Gray Values)

Full Information

First Posted
January 8, 2018
Last Updated
July 16, 2019
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03399760
Brief Title
Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Enhancing Bone Quality
Official Title
Evaluation the Dento-alveolar Changes After Platelet Rich Fibrin (i-PRF) Injection During Upper Canine Retraction Using Cone-beam Computed Tomography (CBCT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus 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
Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side. Soldered transpalatal arch will be used as an anchor unit. The dento-alveolar changes will be assessed immediately before retraction and after 6 months using CBCT.
Detailed Description
Extraction is a procedure that is currently performed in orthodontics, either in the context of early treatment or for adolescents with severe crowding or protrusion/overjet. The consequences of this ''simple'' procedure may show up many mucosal and osseous complications such as: bone resorption with collapse of the alveolar process, a gingival cleft or gingival recession in the area surrounding the extraction site. Besides the potential esthetic repercussions, these periodontal defects also give rise to a clinical problem with achieving some orthodontic movements, such as complete closure of the space or uprighting a root. A systematic review evaluating alveolar bone dimension changes of extraction sockets showed a range of width reduction of 2.6-4.6mm, Two-thirds of the loss occurred in the first 3 months, the remodeling of alveolar bone in the extraction site always decreases ridge volume and deforms the ridge configuration which impairs orthodontic movement of the tooth posteriorly. Endogenously produced biologicals have been tested based on their roles in the turnover of alveolar bone in response to orthodontic tooth movement as well as during wound healing. From here it has been thought about using a method to enhance bone quality after extraction. The platelet rich fibrin (PRF) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs). PRF characteristics in comparison to platelet rich plasma PRP are: its preparation is completely natural and there is no need for thrombin addition so there isn't immune reaction it contains stem cells it requires one stage centrifugation PRF has been reported to gradually release autologous growth factors and expressed stronger and more durable effect on the cellular proliferation and differentiation than PRP in vitro This is the first study in the world that will use i-PRF with Orthodontic treatment, because of its benefits and easiness of using in dental clinic Study sample that consists of 20 patients, Allocation of the sides of intervention (PRF injection) and control sides is made by computer program (Excel). After ensuring of the patients compliance with the terms and conditions of this study, the purpose and methods of the study will be explained to the patients using Information Sheet. In case of approval to participate, the patients asked to sign the Informed Consent. Extra & Intra-oral photographs, impressions and clinical examination will be made. Canine retraction will be 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 20ml of patients' blood will be withdrawn and centrifuged (700 rpm within 3 minutes) to get 4ml i-PRF. PRF will be injected at the area of the extracted first premolar, The first point place is in the buccal interventional side (supra periosteal injection) and the second point place is in the palatal interventional side(sub periosteal injection). PRF will be injected twice at the beginning and at the middle of the canine retraction. High resolution CBCT will be taken before the beginning of canine retraction (T0) and after 6 months (T1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II, Division 1
Keywords
i-PRF (injectable platelet rich fibrin), alveolar bone height, canine root resorption, bone density, cone-beam computed tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two Arms injectable platelet rich fibrin group: consisted of two subgroups Experimental group : injectable platelet rich fibrin assisted upper canine retraction Control group: conventional upper canine retraction
Masking
Outcomes Assessor
Masking Description
One blinded
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
i-PRF assisted upper canine retraction
Arm Type
Experimental
Arm Description
I-PRF assisted upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars
Arm Title
conventional upper canine retraction
Arm Type
Experimental
Arm Description
Conventional upper canine retraction will be performed in the other side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars
Intervention Type
Biological
Intervention Name(s)
i-PRF
Intervention Description
i-PRF (injectable platelet rich fibrin) assisted upper canine retraction
Intervention Type
Procedure
Intervention Name(s)
canine retraction
Intervention Description
upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars
Primary Outcome Measure Information:
Title
Canine root resorption
Description
Root length measurement from a reference line between buccal and palatal cemento-enamel junction (CEJ) to apex. These lines are perpendicular to the long axis of the canine. The levels of CEJ and root apex were assessed using a combination of axial, sagittal, and coronal images.
Time Frame
After 6 months from the beginning of canine retraction
Secondary Outcome Measure Information:
Title
Alveolar bone height in the first premolar region
Description
By measuring the distance between two lines: The first line: the line passing through the distal and mesial cemento-enamel junction of the canine The second line: the line passing through the crest of the alveolus distal to the canine
Time Frame
After 6 months from the beginning of canine retraction
Title
Bone density
Description
By using Hounsfield Unites (Gray Values)
Time Frame
After 6 months from the beginning of canine retraction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult healthy patients, Male and female, Age range: 15-27 years. Class II Division 1 malocclusion: Mild / moderate skeletal Class II (ANB ≤7) Overjet ≤10 Normal or excessive facial height (Clinically and then cephalometry assessed using these angles : SN-MP , MM , Y axis) Mild to moderate crowding ≤ 4 permanent occlusion. Exist all the upper teeth (except third molars). Good oral and periodontal health: Probing depth < 4 mm No radiographic evidence of bone loss. Gingival index ≤ 1 Plaque index ≤ 1 Exclusion Criteria: Medical problems that affect tooth movement (corticosteroid, NSAIDs, …) patients have anti indication for oral surgery ( medical - social - psycho) Presence of primary teeth in the maxillary arch Missing permanent maxillary teeth (except third molars). Poor oral hygiene or Current periodontal disease: Probing depth ≥ 4 mm radiographic evidence of bone loss Gingival index > 1 Plaque index > 1 Patient had previous orthodontic treatment Craniofacial anomalies (cleft lip and palate patients) Smokers coagulation disorders and patients treated with anticoagulants. patients with immunodeficiency disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Haddad, PhD.
Organizational Affiliation
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
00963
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
Citations:
PubMed Identifier
6961819
Citation
Malmgren O, Goldson L, Hill C, Orwin A, Petrini L, Lundberg M. Root resorption after orthodontic treatment of traumatized teeth. Am J Orthod. 1982 Dec;82(6):487-91. doi: 10.1016/0002-9416(82)90317-7.
Results Reference
background
PubMed Identifier
20050738
Citation
Lund H, Grondahl K, Grondahl HG. Cone beam computed tomography for assessment of root length and marginal bone level during orthodontic treatment. Angle Orthod. 2010 May;80(3):466-73. doi: 10.2319/072909-427.1.
Results Reference
background
PubMed Identifier
19089687
Citation
Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
Results Reference
background
PubMed Identifier
23956527
Citation
Naik B, Karunakar P, Jayadev M, Marshal VR. Role of Platelet rich fibrin in wound healing: A critical review. J Conserv Dent. 2013 Jul;16(4):284-93. doi: 10.4103/0972-0707.114344.
Results Reference
background
PubMed Identifier
19929956
Citation
Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
Results Reference
background
PubMed Identifier
33653326
Citation
Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.
Results Reference
derived

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Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Enhancing Bone Quality

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