Impact of Gingival Crevicular Fluid microRNAs on Orthodon... | NCT06023433

Studies
Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement

NCT06023433

Sponsor

University of Catania

Status

Completed

Last Update Posted

Dec 4, 2023Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Orthodontic Tooth Movement

Interventions

Elastomeric powerchain

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Jul 28, 2023Actual

Completion Date

Sep 30, 2023Actual

First Submitted Date

Aug 28, 2023

First Submission Date that Met QC Criteria

Aug 28, 2023

First Posted Date

Sep 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2023

Last Update Posted Date

Dec 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gaetano Isola, Principal Investigator, University of CataniaPrincipal Investigator

Lead Sponsor

University of CataniaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Canines to be distalized	Active Comparator	The canines need distalization after orthodontic upper first premolar asymmetrical extractions.	Device: Elastomeric powerchain
Controlateral canines	No Intervention	The controlateral canines don't need distalization since the adjacent first premolars are not extracted.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elastomeric powerchain	Device	Canine distalization by engaging the elastomeric power chains onto the canine brackets.	Canines to be distalized

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
miRNAs expression	miRNAs expression in the gingival crevicular fluid by PCR	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gaetano Isola	Università degli Studi di Catania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Policlinico G. Rodolico		Catania		95124	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39736760	Derived	Polizzi A, Alibrandi A, Lo Giudice A, Distefano A, Orlando L, Analazi AM, Pizzo G, Volti GL, Isola G. Impact of periodontal microRNAs associated with alveolar bone remodeling during orthodontic tooth movement: a randomized clinical trial. J Transl Med. 2024 Dec 30;22(1):1155. doi: 10.1186/s12967-024-05933-x.