CClinicalTrials.gg
CompletedNCT03555747GCFUpdated Jan 14, 2020

Gingival Crevicular Fluid Cytokine Levels in Response to Orthodontic Forces

An interventional study of Canine distalization in Orthodontic Tooth Movement, sponsored by Aydin Adnan Menderes University. Completed. Open to participants aged 11 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled May 2015, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
11 Years to 16 Years
Sex
All
01

Study 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.

Read the detailed description

Patient selection:

Fifteen orthodontic patients with class II division I malocclusion, who required the extractions of maxillary first premolars bilaterally, distal canine movement, and maximum anchorage control as a part of fixed orthodontic treatment plan were invited to participate in the study. All subjects were in good general health with clinically and radiological healthy periodontal tissues (the probing depths ≤3 mm, full-mouth plaque and bleeding score ≤15%, and no bone loss radiographically). Patients were excluded if they were smokers, had had previous orthodontic treatment, had taken a course of anti-inflammatory drugs within 1 month and antimicrobial agents in the previous 3 months prior to the start of the study.

Experimental Design:

The first premolars were extracted at least 20 days prior to the distalization of the canines. Ten days prior to the application of orthodontic force all subjects underwent full-mouth scaling and oral hygiene instructions to ensure optimal plaque control and oral hygiene instruction was reinforced throughout the whole study period. In each patient, two mini-screw implants (1.5 mm in diameter and 8.0 mm in length) were placed bilaterally into the inter-radicular bone between the maxillary second premolar and first molar in the attached gingiva.The upper right and left canines of the same patient were randomly distalized using a continuous force of 75 or 150 g with nickel-titanium closed coil springs. Simple randomization by flipping a coin was used to determine the assignment of each site for two different forces.

GCF sampling:

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 at 24 hours and 28 days without any reactivation of the coil spring. Baseline measurements of maxillary canines served as a control.

Clinical Periodontal Measurements:

Periodontal clinical parameters including probing depth, clinical attachment loss, gingival index and plaque index were recorded at mesial and distal sites of distally moved canines at baseline and 24 hours and 28 days after force application. All clinical periodontal examinations were performed by a single calibrated periodontist who blinded to the groups using a manual periodontal probe.

Multiplex assay\& Quantification of inflammatory mediators:

A commercially available multiplex panel including thirty proteins was used to evaluate GCF content on the Luminex®200 platform.

Determination of the amount of tooth movement:

The distance of maxillary canine movement was measured from the cusp tip of a distally moved canine to the buccal groove of the first permanent molar by using a digital caliper with a sensitivity of ±0.01 mm.

Statistical Analysis:

The data was analysed using a statistical software package. The effect of force, side and time on the analyte levels were analyzed with Brunner-Langer method.

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Conditions studied

  • Orthodontic Tooth Movement

Keywords

  • Canine distalization
  • Gingival crevicular fluid
  • Cytokines
  • Orthodontic force
  • Periodontium
  • Gingivitis
03

In context

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Orthodontic treatment history
  • Use of anti-inflammatory drugs within one month
  • Use of antibiotics within last three months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Investigator)
Enrollment
15 participants (actual)

Study arms

  • Other
    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

  • Other
    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

Interventions

  • OtherCanine 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)

    Also known as: Gingival crevicular fluid collection

06

What researchers measure

Primary outcomes

  1. Gingival crevicular fluid protein content change

    pg/ml

    Time frame: Change from baseline to 24 hours and to 28 days after force application

Secondary outcomes

  1. Probing pocket depth change

    mm

    Time frame: Change from baseline to 24 hours and to 28 days after force application

  2. Clinical attachment level change

    mm

    Time frame: Change from baseline to 24 hours and to 28 days after force application

  3. The amount of tooth movement

    mm

    Time frame: Change from baseline to 28 days after force application

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Afacan B, Ozturk VO, Gecgelen Cesur M, Kose T, Bostanci N. Effect of orthodontic force magnitude on cytokine networks in gingival crevicular fluid: a longitudinal randomized split-mouth study. Eur J Orthod. 2019 Mar 29;41(2):214-222. doi: 10.1093/ejo/cjy068. PubMed 30321318 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03555747
Lead sponsor
Aydin Adnan Menderes University
Collaborators
Ege University, Karolinska Institutet
Responsible party
Beral Afacan (Assistant Professor, Aydin Adnan Menderes University) — Principal investigator
First posted
Jun 13, 2018
Start date
May 1, 2015
Primary completion
May 29, 2015
Completion
Sep 30, 2015
Last update
Jan 14, 2020
View the source record on ClinicalTrials.gov ↗

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