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Completed

NCT Number: NCT06023433

Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement

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.

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Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Policlinico G. Rodolico

Catania, 95124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elastomeric powerchain

Device

Canine distalization by engaging the elastomeric power chains onto the canine brackets.

Primary outcomes

  1. miRNAs expression

    Time frame: 6 weeks

    miRNAs expression in the gingival crevicular fluid by PCR

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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