NCT04226469

Brief Summary

During Orthodontic tooth movement, teeth are moved through alveolar bone under applied forces. The applied mechanical loading force must be transferred to the alveolar bone via periodontal ligament (PDL). This process of mechanotransduction stimulates bone remodeling during which osteoblasts produce bone on the tension side and osteoclasts resorb bone on the compression side of the PDL. Complex interactions between osteoblasts and osteoclasts involve numerous biologic molecules including cytokines and growth factors. During the tooth movement, the expression of cytokines such as interleukin (IL)-1β, IL-6, IL-8, prostaglandin E2, RANKL and MMP1 in PDL will be up-regulated. The sequence of events from the mechanotransduction commanding the tightly controlled accomplishment of osteogenesis attention sides and osteoclastogenesis at compressive sides is not completely understood. The gingival crevicular fluid (GCF) is a transudate of interstitial tissues that is produced by an osmotic gradient and it is released into the crevicular crevices at a flow rate of about 3 ul/h. Orthodontic treatment is triggered by an inflammatory process and it has been hypothesized that the quantification of specific biomarkers within the GCF can be determined using Periotron. However contrasting results have been reported in the literature, which studies showing both increased or unchanged GCF volumes incident to orthodontic treatment. Given that the orthodontic treatment is triggered by a set of inflammatory cytokines that are released into the crevicular fluid during the mechanical loading, and its homeostasis is dependent on mechanical stimulation. An understanding of the biological response of crevicular fluid to mechanical loading could further advance the knowledge of orthodontic treatment. In this study, the investigators will investigate the biological response of gingival crevicular fluid before and after the initial wire placement of orthodontic treatment to determine the differentially expressed genes and proteins related to mechanotransduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 7, 2025

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

2.3 years

First QC Date

January 6, 2020

Results QC Date

May 29, 2021

Last Update Submit

May 6, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • The Distance of Tooth Movement

    The distance of tooth movement from initial timepoint to the end of study

    7 weeks

  • The Fold Change of Secretory microRNA Expression

    The fold change of secretory microRNA expression compared to the initial level

    7 weeks

  • The Amount of Crevicular Fluid

    the volume of crevicular fluid during the tooth movement

    7 weeks

Study Arms (1)

Subjects require canine retraction

Subjects require canine retraction during orthodontic tooth movement and their gingival crevicular fluid is collected during the tooth movement. The control is the initial timepoint.

Procedure: Tooth movement

Interventions

The subject's canines will be retracted distally and crevicular fluid is collected

Subjects require canine retraction

Eligibility Criteria

Age11 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy, non-smoking patients aged 11-35 years old who require orthodontic treatment with first premolar extraction at the orthodontic clinic at College of Dentistry, University of Illinois at Chicago (UIC)

You may qualify if:

  • Healthy, non-smoking patients aged 11-35 years old who require orthodontic treatment with the first premolar extraction at the orthodontic clinic at College of Dentistry, the University of Illinois at Chicago (UIC)

You may not qualify if:

  • Craniofacial syndromic subjects
  • periodontal pathology
  • systemic problems and underlying diseases
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, Clinic

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid

MeSH Terms

Interventions

Tooth Movement Techniques

Intervention Hierarchy (Ancestors)

Orthodontics, CorrectiveOrthodonticsDentistry

Results Point of Contact

Title
Phimon Atsawasuwan
Organization
University of Illinois Chicago

Study Officials

  • Phimon Atsawasuwan, DDS, MS, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 13, 2020

Study Start

January 1, 2019

Primary Completion

May 5, 2021

Study Completion

May 5, 2021

Last Updated

May 7, 2025

Results First Posted

May 7, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations