NCT03555747

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

28 days

First QC Date

May 19, 2018

Last Update Submit

January 12, 2020

Conditions

Keywords

Canine distalizationGingival crevicular fluidCytokinesOrthodontic forcePeriodontiumGingivitis

Outcome Measures

Primary Outcomes (1)

  • Gingival crevicular fluid protein content change

    pg/ml

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

Secondary Outcomes (3)

  • Probing pocket depth change

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

  • Clinical attachment level change

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

  • The amount of tooth movement

    Change from baseline to 28 days after force application

Study Arms (2)

Canine distalization by 75 g force

OTHER

Canine was distalized using a continuous force of 75 g with nickel-titanium closed coil springs.

Other: Canine distalization

Canine distalization by 150 g force

OTHER

Canine was distalized using a continuous force of 150 g with nickel-titanium closed coil springs.

Other: Canine distalization

Interventions

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
Canine distalization by 150 g forceCanine distalization by 75 g force

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2018

First Posted

June 13, 2018

Study Start

May 1, 2015

Primary Completion

May 29, 2015

Study Completion

September 30, 2015

Last Updated

January 14, 2020

Record last verified: 2020-01