Efficacy of Biological Technique in Upper Canine Retraction and Levels of Discomfort

NCT03399422 | Completed DMC

• 1 other identifier: UDDS-Ortho-02-2018
• 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. Pre- and post distalization dental casts will be evaluated to study rate of canine distalization, over a follow-up period until a Class I canine relationship will be achieved. The levels of Pain and discomfort will be monitored using a questionnaire with a VAS scale administered three times during the first day after prf injection.

Conditions

Malocclusion, Angle Class II, Division 1

Keywords

i-PRF (injectable platelet rich fibrin); canine retraction; pain and discomfort

Outcome Measures

Primary Outcomes (1)

• Change of the rate of canine retraction

  The rate of canine retraction defines as the distance traveled in millimeters (mm) divided by the time required (in week). Orthodontic models will be taken before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1). The distance of canine retraction will be calculated by measuring the difference between the initial cast and the final cast using the method described by Ziegler and Ingervall, which rely on Stable palatal reference Points (the medial ends of the third palatal rugae, Midpalatal Suture) and the tips of the canines and then this distance will be divided by the number of intervals (weeks) to give the rate of retraction in millimeters per week. Measurements will be made from the orthodontic models manually by direct technique using digital dental calipers.

  Before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1) which will be approximately after 6 months from the beginning of canine retraction

Secondary Outcomes (1)

• pain levels

  on the first day after an hour, 2 hours and 6 hours of PRF injection

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 (7)

• Rosvall MD, Fields HW, Ziuchkovski J, Rosenstiel SF, Johnston WM. Attractiveness, acceptability, and value of orthodontic appliances. Am J Orthod Dentofacial Orthop. 2009 Mar;135(3):276.e1-12; discussion 276-7. doi: 10.1016/j.ajodo.2008.09.020.

  PMID: 19268820 BACKGROUND

• Almpani K, Kantarci A. Nonsurgical Methods for the Acceleration of the Orthodontic Tooth Movement. Front Oral Biol. 2016;18:80-91. doi: 10.1159/000382048. Epub 2015 Nov 24.

  PMID: 26599121 BACKGROUND

• Gulec A, Bakkalbasi BC, Cumbul A, Uslu U, Alev B, Yarat A. Effects of local platelet-rich plasma injection on the rate of orthodontic tooth movement in a rat model: A histomorphometric study. Am J Orthod Dentofacial Orthop. 2017 Jan;151(1):92-104. doi: 10.1016/j.ajodo.2016.05.016.

  PMID: 28024792 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

• Ziegler P, Ingervall B. A clinical study of maxillary canine retraction with a retraction spring and with sliding mechanics. Am J Orthod Dentofacial Orthop. 1989 Feb;95(2):99-106. doi: 10.1016/0889-5406(89)90388-0.

  PMID: 2916474 BACKGROUND

• Zeitounlouian T, Haddad R, Brad B, Ballouk MA, Fudalej P. Does the application of autologous injectable Platelet-Rich Fibrin (i-PRF) affect the patient's daily performance during the retraction of upper canines? A single-centre randomized split-mouth controlled trial. BMC Oral Health. 2023 Nov 17;23(1):872. doi: 10.1186/s12903-023-03646-z.

  PMID: 37978474 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II; Pain

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: CROSSOVER
• 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: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)