Active, Not Recruiting

NCT Number: NCT06646705

Biochemical Evaluation of Periodontal Effects of Orthodontic Treatment with Aligners

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Aligner Treatment

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Çelebi University Faculty of Dentistry

Izmir, Cigli, 35640, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saliva obtaining

Diagnostic Test

The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.

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

Time frame: 24 hours after taking the clinical measurements

The total amount of receptor activator of NF-κB ligand in saliva

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Oct 17, 2024
Registry last updated: Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.