Gingival Crevicular Fluid Cytokine Levels in Response to Orthodontic Forces
GCF
Molecular Analysis of Gingival Crevicular Fluid in Response to the Magnitude of Orthodontic Force: a Longitudinal Randomized Split-mouth Study
1 other identifier
interventional
15
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Shorter than P25 for not_applicable
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2015
CompletedFirst Submitted
Initial submission to the registry
May 19, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedJanuary 14, 2020
January 1, 2020
28 days
May 19, 2018
January 12, 2020
Conditions
Keywords
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
OTHERCanine was distalized using a continuous force of 75 g with nickel-titanium closed coil springs.
Canine distalization by 150 g force
OTHERCanine was distalized using a continuous force of 150 g with nickel-titanium closed coil springs.
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)
Eligibility Criteria
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
- Aydin Adnan Menderes Universitylead
- Ege Universitycollaborator
- Karolinska Institutetcollaborator
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.
PMID: 30321318DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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