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Orthodontic Tooth MovementGCFNCT03555747

Gingival Crevicular Fluid Cytokine Levels in Response to Orthodontic Forces

A study testing Canine distalization in people with Orthodontic Tooth Movement, run by Aydin Adnan Menderes University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Orthodontic Tooth Movement
What is being tested?
Canine distalization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
1 May 2015to 30 Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

About this study

Official title: Molecular Analysis of Gingival Crevicular Fluid in Response to the Magnitude of Orthodontic Force: a Longitudinal Randomized Split-mouth Study

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.

Being tested
Canine distalization
Keywords
Canine distalization, Gingival crevicular fluid, Cytokines, Orthodontic force, Periodontium, Gingivitis
Medical subject headings
Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Canine distalizationOther

    Also called Gingival crevicular fluid collection

    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)

Study groups in NCT03555747
Study groupRoleWhat they receive
Canine distalization by 75 g forceOtherCanine was distalized using a continuous force of 75 g with nickel-titanium closed coil springs.
Receives: Other: Canine distalization
Canine distalization by 150 g forceOtherCanine was distalized using a continuous force of 150 g with nickel-titanium closed coil springs.
Receives: Other: Canine distalization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gingival crevicular fluid protein content change

    pg/ml

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

Secondary outcomes (3)
  1. Probing pocket depth change

    mm

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

  2. Clinical attachment level change

    mm

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

  3. The amount of tooth movement

    mm

    Measured: Change from baseline to 28 days after force application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study start1 May 2015
  3. Primary completion29 May 2015
  4. Study completion30 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03555747
Sponsor's protocol ID
bafacan09
Acronym
GCF
Status last verified
Jan 2020
First submitted
19 May 2018
Last updated
14 Jan 2020
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Canine distalization in people with Orthodontic Tooth Movement, run by Aydin Adnan Menderes University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival crevicular fluid protein content change (time frame: Change from baseline to 24 hours and to 28 days after force application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03555747, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.

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