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NCT06023433 Clinical Trial

Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement

Orthodontic Tooth Movement Clinical Trial

Official title:
Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement: a Split Mouth Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06023433
Other study ID # 121-26
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2020
Est. completion date September 30, 2023

Study information
Verified date November 2023
Source University of Catania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on the expression of gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis during canine distalization following asymmetrical extraction treatment of upper first premolars. Samples of gingival crevicular fluid on the mesial and distal side of the canines to be examined will be performed during the baseline and during various follow-ups.

Description:

A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on the expression of gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis during canine distalization following asymmetrical extraction treatment of upper first premolars. Orthodontic tooth movement induces bone remodeling by various signaling pathways. The variations in miRNAs expression and their impact in inflammation and osteoclastogenesis during the various stages of orthodontic tooth movements is not fully understood. 58 patients requiring asymmetrical upper first premolar extraction for orthodontic purposes have been enrolled for this split-mouth study: the canines to be distalized on the extractive site are considered as the test group, the controlateral canines (on the side without first premolar extraction) areconsidered as normal controls.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date September 30, 2023
Est. primary completion date July 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria: - patients with excellent oral hygiene throughout the study period, - patients requiring asymmetrical maxillary first premolar extraction so monolateral canine retraction will be performed as a part of the treatment, - patients available to come back at the clinic at the times of sample collection. Exclusion Criteria: - poor oral hygiene and/or bleeding on probing, - use medications, steroids or other anti-inflammatory medications, - systemic health problems or smoking.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Elastomeric powerchain
Canine distalization by engaging the elastomeric power chains onto the canine brackets.

Locations
Country Name City State
Italy AOU Policlinico G. Rodolico Catania

Sponsors (1)
Lead Sponsor Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary miRNAs expression miRNAs expression in the gingival crevicular fluid by PCR 6 weeks
See also
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