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NCT05738889

Comparative Evaluation of Salivary Bisphenol-A Levels in Patients With Fixed Lingual, Hawley and Vacuum-formed Retainers

Completed Last updated 24 February 2023
What this trial tests

trial testing Fixed lingual retainers applied with Bis-GMA containing composite in Orthodontic Retention in 120 participants. Completed in 4 December 2022.

Timeline
28 July 2021
Primary endpoint
8 November 2022
4 December 2022

Quick facts

Lead sponsorAydin Adnan Menderes University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment120
Start date28 July 2021
Primary completion8 November 2022
Estimated completion4 December 2022
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Aydin Adnan Menderes University

Who can join

Adults 10 to 18, any sex, with Orthodontic Retention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study; to measure the BPA release amount of fixed lingual retainers applied with Bis-GMA-containing composite , fixed lingual retainers applied with Bis-GMA-free composite, vacuum-formed and hawley retainers which used for retention after orthodontic treatment to evaluate whether they are risk factors for the patient and to compare BPA releases. Study method and data collection techniques: In this study, individuals will be selected from the patients who will be treated at Aydın Adnan Menderes University Faculty of Dentistry, Department of Orthodontics between July 2021 and July 2022, whose orthodontic treatment will be completed. These patients will be randomly divided into four groups according to the type of retention appliance to be chosen: those who are applied a fixed lingual retainer with a bis-GMA-containing composite, those with a fixed lingual retainer with a bis-GMA-free composite, those with an vacuum formed retainers, and those with a hawley retainers. After the debonding of the fixed attachments at the end of the treatment appointment, the retention appliances will be applied 1 day later so that BPA, which is released from the resin adhesives used to bond the attachments, does not affect the study data. Saliva samples will be taken from the patients before the appliance is inserted, 1 hour, 7 days and 30 days after the appliance is inserted.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Orthodontic Retention

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Data sources for this page

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