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

NCT03399760 | Completed DMC

• 1 other identifier: UDDS-Ortho-01-2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  After 6 months from the beginning of canine retraction

Secondary Outcomes (2)

• Alveolar bone height in the first premolar region

  After 6 months from the beginning of canine retraction

• Bone density

  After 6 months from the beginning of canine retraction

Study Arms (2)

i-PRF assisted upper canine retraction

EXPERIMENTAL

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; Procedure: canine retraction

conventional upper canine retraction

EXPERIMENTAL

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

Interventions

i-PRF BIOLOGICAL

i-PRF (injectable platelet rich fibrin) assisted upper canine retraction

i-PRF assisted upper canine retraction

canine retraction PROCEDURE

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; i-PRF assisted upper canine retraction

Eligibility Criteria

• Age: 15 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 00963, Syria

Location

Related Publications (6)

• 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.

  PMID: 6961819 BACKGROUND

• 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.

  PMID: 20050738 BACKGROUND

• 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.

  PMID: 19089687 BACKGROUND

• 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.

  PMID: 23956527 BACKGROUND

• 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.

  PMID: 19929956 BACKGROUND

• 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.

  PMID: 33653326 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rania Haddad, PhD.

  Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: August 20, 2017
• Primary Completion: January 20, 2019
• Study Completion: July 10, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)