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

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ClinicalTrials.gov Identifier: NCT03399760
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

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.

Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class II, Division 1 Biological: i-PRF Procedure: canine retraction Not Applicable

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:

  1. its preparation is completely natural and there is no need for thrombin addition so there isn't immune reaction
  2. it contains stem cells
  3. it requires one stage centrifugation
  4. 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: One blinded
Primary Purpose: Treatment
Official Title: Evaluation the Dento-alveolar Changes After Platelet Rich Fibrin (i-PRF) Injection During Upper Canine Retraction Using Cone-beam Computed Tomography (CBCT)
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : February 1, 2019

Arm Intervention/treatment
Experimental: i-PRF assisted upper canine retraction
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
Biological: i-PRF
i-PRF (injectable platelet rich fibrin) assisted upper canine retraction

Procedure: canine retraction
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

Experimental: conventional upper canine retraction
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
Procedure: canine retraction
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 Measures :
  1. Canine root resorption [ Time Frame: After 6 months from the beginning of canine retraction ]
    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 :
  1. Alveolar bone height in the first premolar region [ Time Frame: After 6 months from the beginning of canine retraction ]

    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


  2. Bone density [ Time Frame: After 6 months from the beginning of canine retraction ]
    By using Hounsfield Unites (Gray Values)



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 27 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399760


Contacts
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Contact: Talar Zeitounlouian, MSc. Student +963 990253494 talarzeitounian@gmail.com
Contact: Rania Haddad, PhD. +963 988403404 rania_haddad234@gmail.com

Locations
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Syrian Arab Republic
Damascus University Recruiting
Damascus, Syrian Arab Republic, 00963
Contact: Ahmad S Burhan, PhD    00963944302075    dr.burhan-a@hotmail.com   
Sponsors and Collaborators
Damascus University
Investigators
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Study Director: Rania Haddad, PhD. Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Publications:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03399760     History of Changes
Other Study ID Numbers: UDDS-Ortho-01-2018
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Damascus University:
i-PRF (injectable platelet rich fibrin)
alveolar bone height
canine root resorption
bone density
cone-beam computed tomography

Additional relevant MeSH terms:
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Malocclusion
Malocclusion, Angle Class II
Overbite
Tooth Diseases
Stomatognathic Diseases