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Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement

NCT ID: NCT06023433

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Orthodontic Tooth Movement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Sealed envelopes

Study Groups

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Canines to be distalized

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

Group Type ACTIVE_COMPARATOR

Elastomeric powerchain

Intervention Type DEVICE

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

Controlateral canines

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Elastomeric powerchain

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Catania

Locations

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AOU Policlinico G. Rodolico

Catania, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 39736760 (View on PubMed)

Other Identifiers

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121-26

Identifier Type: -

Identifier Source: org_study_id