Skip to main content
OpenTrials
Completed

NCT Number: NCT05738889

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthodontic Retention

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aydın Adnan Menderes University Faculty of Dentistry

Aydin, Efeler, 09000, Turkey (Türkiye)

About this study

Patients who are scheduled to complete their orthodontic treatment between July 2021 and July 2022 and will be debonded will be included in the study. Inclusion criteria for the study; not to have any systemic diseases, not to smoke, not to work in jobs where they will be exposed to chronic BPA release, such as gas station-construction site or acrylic-related jobs. Selected patients will be randomly divided into four groups. Randomization will be done through the website www.random.org. Fixed lingual retainer applied with composite containing Bis-GMA will be applied in the first group, fixed lingual retainer applied with composite without Bis-GMA in the second group, vacuum formed retainers in the third group and hawley retainers in the fourth group. 120 patients, including 30 individuals in each group, will be included in the study. The number of men and women in each group will be equal. Patients who have undergone debonding will be given an appointment to wear retention appliances one day later. Patients will be advised to brush their teeth routinely, including the appointment day, and not to consume any food or drink at least 2 hours before the application. In addition, due to the effect of many drugs on salivary secretion, if patients use drugs, they will be told to take them at least 8 hours before the application. Saliva samples for BPA release will be taken before appliance insertion, 1 hour after, 7 days and 30 days after insertion. Samples taken will be stored in polypropylene tubes. All samples taken will be stored at -80 degrees until analysis. The sample will be processed by mixing 5ml saliva with an equal amount of ethanol and vortexing it. It will be centrifuged at 3000 rpm for 15 minutes. The ultimately processed sample will be injected into the instrument and analyzed by liquid chromatography.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • be between the ages 10-18
  • absence of any systemic disease
  • good oral hygiene
  • completion of orthodontic treatment
  • non smoker
  • Not working in jobs where they will be exposed to chronic BPA release, such as gas station construction site or acrylic related jobs

Exclusion criteria

  • be under 10 years or over 18 years
  • any systemic disease
  • poor oral hygiene
  • ıncomplete orthodontic treatment
  • being a smoker
  • working in jobs where they will e exposed to chronic BPA release, such as gas station construction site or acrylic related jobs

Treatment and study plan

Fixed lingual retainers applied with Bis-GMA containing composite

Device

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

Other names: Reliance Orthodontic Gel Etching Agent, Illinois, USA, American Orthodontics Brace Paste MTP primer, Wisconsin, USA, Reliance Orthodontic Bond-A-Braid, Illinois, USA, Reliance Orthodontic Flow Tain Low Viscosity W/TIPS, Illinois, USA

Fixed lingual retainers applied with Bis-GMA-free composite

Device

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

Other names: Reliance Orthodontic Gel Etching Agent, Illinois, USA, Reliance Orthodontic Bond-A-Braid, Illinois, USA, GC Ortho Connect Flow, Tokyo, Japan

Vacuum-formed retainers

Device

vacuum-forming machine and vacuum formed plates

Other names: Supplies Atmos Thermoforming Material 0.40 inç, USA, Dentsply Sirona, USA

Hawley retainers

Device

Acrylic based hawley retainers

Other names: Dentaurum Orthocryl, Ispringen, Germany

Primary outcomes

  1. Bisphenol-A amount in saliva before applying a retainer with bis-GMA-containing composite

    Time frame: 1 day after debonding and before retention appliance to 1 month.

    The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.

  2. Bisphenol-A amount in saliva before applying a retainer with bis-GMA-free composite

    Time frame: 1 day after debonding and before retention appliance to 1 month.

    The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.

  3. Bisphenol-A amount in saliva before applying vacuum formed retainer

    Time frame: 1 day after debonding and before retention appliance to 1 month.

    The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.

  4. Bisphenol-A amount in saliva before applying hawley retainer

    Time frame: 1 day after debonding and before retention appliance to 1 month.

    The main purpose of this thesis study is to determine the appliance with the least BPA release by comparing the Bisphenol-A(BPA) release levels from lingual retainers, vacuum formed retainers and hawley retainers used for retention after orthodontic treatment. Saliva samples were taken from volunteers at regular intervals, a total of 4 times. First example; One day after debonding, before applying the retention appliance, the second sample; One hour after the retention appliance was applied, the third sample was taken 1 week later and the fourth sample 1 month later. Analysis of the change in BPA was done.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2023
Registry last updated
Feb 24, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.