CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Fixed lingual retainers applied with Bis-GMA containing composite +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05738889
NCT05738889N/ACompleted

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

Aydin Adnan Menderes University·observational·Posted Feb 22, 2023·Updated Feb 24, 2023

In Brief

An observational study evaluating Fixed lingual retainers applied with Bis-GMA containing composite, Fixed lingual retainers applied with Bis-GMA-free composite, and 2 other interventions for Orthodontic Retention. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 22, 2023
Enrollment StartJul 28, 2021
Primary CompletionNov 8, 2022
Study CompletionDec 4, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.4 years ago

Interventions

Fixed lingual retainers applied with Bis-GMA containing compositedevice

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

Fixed lingual retainers applied with Bis-GMA-free compositedevice

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

Vacuum-formed retainersdevice

vacuum-forming machine and vacuum formed plates

Hawley retainersdevice

Acrylic based hawley retainers