Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement

Sponsor

University of Catania (Other)

Overall Status

Recruiting

CT.gov ID

NCT06023433

Collaborator

(none)

Enrollment

Location

Arms

40.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Tooth Movement	Device: Elastomeric powerchain	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

The main objective of the study is to evaluate the impact of orthodontic tooth movement on gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis.The main objective of the study is to evaluate the impact of orthodontic tooth movement on gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Sealed envelopes

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 15, 2020

Actual Primary Completion Date :

Jul 28, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Canines to be distalized The canines need distalization after orthodontic upper first premolar asymmetrical extractions.	Device: Elastomeric powerchain Canine distalization by engaging the elastomeric power chains onto the canine brackets.
No Intervention: Controlateral canines The controlateral canines don't need distalization since the adjacent first premolars are not extracted.

Arm

Intervention/Treatment

Active Comparator: Canines to be distalized

The canines need distalization after orthodontic upper first premolar asymmetrical extractions.

Device: Elastomeric powerchain

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

No Intervention: Controlateral canines

The controlateral canines don't need distalization since the adjacent first premolars are not extracted.

Outcome Measures

Primary Outcome Measures

miRNAs expression [6 weeks]
miRNAs expression in the gingival crevicular fluid by PCR

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Policlinico G. Rodolico	Catania		Italy	95124

Sponsors and Collaborators

University of Catania

Investigators

Principal Investigator: Gaetano Isola, Università degli Studi di Catania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Isola, Researcher, University of Catania

ClinicalTrials.gov Identifier:

NCT06023433

Other Study ID Numbers:

121-26

First Posted:

Sep 5, 2023

Last Update Posted:

Sep 5, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 5, 2023