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

NCT05738889 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-02-24

No results posted yet for this study

Summary

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.

Conditions

  • Orthodontic Retention

Interventions

DEVICE

Fixed lingual retainers applied with Bis-GMA containing composite

Bonding materials of fixed lingual retainers applied with Bis-GMA containing composite

DEVICE

Fixed lingual retainers applied with Bis-GMA-free composite

Bonding materials of fixed lingual retainers applied with Bis-GMA-free composite

DEVICE

Vacuum-formed retainers

vacuum-forming machine and vacuum formed plates

DEVICE

Hawley retainers

Acrylic based hawley retainers

Sponsors & Collaborators

  • Aydin Adnan Menderes University

    lead OTHER

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2022-11-08
Completion
2022-12-04

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05738889 on ClinicalTrials.gov