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Gingival Crevicular Fluid Cytokine Levels in Response to Orthodontic Forces (GCF)

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ClinicalTrials.gov Identifier: NCT03555747
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
Ege University
Karolinska Institutet
Information provided by (Responsible Party):
Beral Afacan, Adnan Menderes University

Brief Summary:
The aim of this randomized split-mouth study was to quantify simultaneously 30 analytes including cytokines, chemokines and growth factors in gingival crevicular fluid (GCF) in response to different magnitudes of forces during maxillary canine distalization. The upper right and left canines were distalized using a continuous force of 75 g or 150 g in 15 individuals who had Class II division I malocclusion requiring bilateral extraction of maxillary first premolars. GCF samples were obtained from the tension and the pressure side of each canine at appliance placement and after force application at 24 hours and 28 days. A multiplexed bead immunoassay was used to quantify 30 analytes simultaneously. The effect of force, side and time on the analyte levels were analyzed with Brunner-Langer method.

Condition or disease Intervention/treatment Phase
Orthodontic Tooth Movement Other: Canine distalization Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Molecular Analysis of Gingival Crevicular Fluid in Response to the Magnitude of Orthodontic Force: a Longitudinal Randomized Split-mouth Study
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : May 29, 2015
Actual Study Completion Date : September 30, 2015

Arm Intervention/treatment
Canine distalization by 75 g force
Canine was distalized using a continuous force of 75 g with nickel-titanium closed coil springs.
Other: Canine distalization
GCF was sampled from the mesial (tension) and distal (pressure) sides of maxillary right and left canines immediately before appliance placement (baseline) and after force application (24 hours and 28 days)
Other Name: Gingival crevicular fluid collection

Canine distalization by 150 g force
Canine was distalized using a continuous force of 150 g with nickel-titanium closed coil springs.
Other: Canine distalization
GCF was sampled from the mesial (tension) and distal (pressure) sides of maxillary right and left canines immediately before appliance placement (baseline) and after force application (24 hours and 28 days)
Other Name: Gingival crevicular fluid collection




Primary Outcome Measures :
  1. Gingival crevicular fluid protein content change [ Time Frame: Change from baseline to 24 hours and to 28 days after force application ]
    pg/ml


Secondary Outcome Measures :
  1. Probing pocket depth change [ Time Frame: Change from baseline to 24 hours and to 28 days after force application ]
    mm

  2. Clinical attachment level change [ Time Frame: Change from baseline to 24 hours and to 28 days after force application ]
    mm

  3. The amount of tooth movement [ Time Frame: Change from baseline to 28 days after force application ]
    mm



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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Systemically healthy
  • Non-smoker
  • Orthodontic patients with class II division I malocclusion

Exclusion Criteria:

  • Orthodontic treatment history
  • Use of anti-inflammatory drugs within one month
  • Use of antibiotics within last three months

Responsible Party: Beral Afacan, Assistant Professor, Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03555747     History of Changes
Other Study ID Numbers: bafacan09
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Keywords provided by Beral Afacan, Adnan Menderes University:
Canine distalization
Gingival crevicular fluid
Cytokines
Orthodontic force
Periodontium
Gingivitis