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Clinical Trials/NCT06646705
NCT06646705
Active, not recruiting
Not Applicable

Biochemical Evaluation of the Effect of Orthodontic Treatment with Aligner on Periodontal Parameters and OPG and RANKL Salivary Values

Izmir Katip Celebi University1 site in 1 country25 target enrollmentApril 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aligner Treatment
Sponsor
Izmir Katip Celebi University
Enrollment
25
Locations
1
Primary Endpoint
The total amount of OPG in saliva
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this study was to determine the effect of orthodontic treatment with aligner on changes in osteoprotegerin (OPG) and receptor activator of NF-κB ligand (RANKL) levels in saliva samples and to investigate the possible relationship between periodontal clinical parameters. Materials and Methods: A total of 25 (n=25) saliva samples were taken from systemically healthy non-smoking individuals who were planned to receive orthodontic treatment with aligner before treatment. Whole mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded and repeated at 1 and 3 months. Enzyme-linked immunosorbent assay (ELISA) was used to determine OPG and RANKL levels in biological samples.

Registry
clinicaltrials.gov
Start Date
April 6, 2023
End Date
December 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Izmir Katip Celebi University
Responsible Party
Principal Investigator
Principal Investigator

Burçin Akan

Doç. Dr.

Izmir Katip Celebi University

Eligibility Criteria

Inclusion Criteria

  • Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
  • Must receive orthodontic treatment with aligners and must have accepted the treatment
  • Non-smoker
  • No medication for continuous use
  • Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
  • Not in pregnancy or lactation period.

Exclusion Criteria

  • Any oral or systemic disease
  • Regularly using a systemic medication
  • During pregnancy or lactation
  • Received periodontal treatment within the last 6 months.
  • Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
  • Smokers are not included in the study

Outcomes

Primary Outcomes

The total amount of OPG in saliva

Time Frame: 24 hours after taking the clinical measurements

The total amount of osteoprotegerin in saliva

Secondary Outcomes

  • The total amount of RANKL in saliva(24 hours after taking the clinical measurements)

Study Sites (1)

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