Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2023
CompletedFirst Submitted
Initial submission to the registry
August 28, 2023
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedDecember 4, 2023
November 1, 2023
3.2 years
August 28, 2023
November 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
miRNAs expression
miRNAs expression in the gingival crevicular fluid by PCR
6 weeks
Study Arms (2)
Canines to be distalized
ACTIVE COMPARATORThe canines need distalization after orthodontic upper first premolar asymmetrical extractions.
Controlateral canines
NO INTERVENTIONThe controlateral canines don't need distalization since the adjacent first premolars are not extracted.
Interventions
Canine distalization by engaging the elastomeric power chains onto the canine brackets.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- poor oral hygiene and/or bleeding on probing,
- use medications, steroids or other anti-inflammatory medications,
- systemic health problems or smoking.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOU Policlinico G. Rodolico
Catania, 95124, Italy
Related Publications (1)
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.
PMID: 39736760DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Gaetano Isola
Università degli Studi di Catania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sealed envelopes
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 28, 2023
First Posted
September 5, 2023
Study Start
May 15, 2020
Primary Completion
July 28, 2023
Study Completion
September 30, 2023
Last Updated
December 4, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 1 year
- Access Criteria
- Pubmed