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

NCT05738889 | Completed DMC

• 1 other identifier: DHF-21010
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Orthodontic retention; Bisphenol-A; lingual retainer; Hawley retainer; Vacuum formed retainer; essix plate

Outcome Measures

Primary Outcomes (4)

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

  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.

  1 day after debonding and before retention appliance to 1 month.

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

  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.

  1 day after debonding and before retention appliance to 1 month.

• Bisphenol-A amount in saliva before applying vacuum formed retainer

  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.

  1 day after debonding and before retention appliance to 1 month.

• Bisphenol-A amount in saliva before applying hawley retainer

  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.

  1 day after debonding and before retention appliance to 1 month.

Study Arms (4)

Group 1: Patients with fixed lingual retainers applied with Bis-GMA containing composite

In the maxilla and mandible, the lingual surfaces of the anterior six teeth, including the canines, were roughened and bonded by applying 37.5% phosphoric acid for 30 seconds. Then, the retainer wire was adhered to the lingual surfaces of the teeth between the canine-canines in the maxilla and mandible, where a fixed lingual retainer will be applied, with a flowable composite adhesive containing Bis-GMA, with 10 seconds of illumination for 60 seconds for each tooth.

Device: Fixed lingual retainers applied with Bis-GMA containing composite

Group 2: Patients with fixed lingual retainers applied with Bis-GMA-free composite

The lingual surfaces of the anterior six teeth, including the canines, in the maxilla and mandible were roughened by the application of 37.5% phosphoric acid for 30 seconds. Since the applied composite system is one-stage, no additional bond application was done. Fixed lingual retainer wire was applied with a Bis-GMA-free flowable composite adhesive with 60 seconds exposure for 10 seconds for each tooth.

Device: Fixed lingual retainers applied with Bis-GMA-free composite

Group 3: Patients with vacuum-formed retainers

Impressions were taken with alginate impression material from the maxilla and mandible of the volunteers whose treatment was completed, and a model was obtained with a hard cast. On the models obtained, vacuum formed retainers were prepared with a vacuum forming machine. The use and care instructions of vacuum formed retainers were explained to the patient orally. vacuum formed retainers were used by the patient for 22 hours.

Device: Vacuum-formed retainers

Group 4: Patients with hawley retainers

Impressions were taken with alginate impression material from the volunteers in the Hawley retainers group and a model was obtained with hard plaster. Wire elements were made on the model obtained and the appliance was prepared from transparent acrylic material. After the leveling and polishing processes were completed, the hawley retainers was attached to the mouth. It is stated that the appliance is used for 22 hours in 1 day. The use and care instructions of the Hawley retainers are explained to the patient.

Device: Hawley retainers

Interventions

Fixed lingual retainers applied with Bis-GMA containing composite DEVICE

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

Also known as: 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

Group 1: Patients with fixed lingual retainers applied with Bis-GMA containing composite

Fixed lingual retainers applied with Bis-GMA-free composite DEVICE

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

Also known as: Reliance Orthodontic Gel Etching Agent, Illinois, USA, Reliance Orthodontic Bond-A-Braid, Illinois, USA, GC Ortho Connect Flow, Tokyo, Japan

Group 2: Patients with fixed lingual retainers applied with Bis-GMA-free composite

Vacuum-formed retainers DEVICE

vacuum-forming machine and vacuum formed plates

Also known as: Supplies Atmos Thermoforming Material 0.40 inç, USA, Dentsply Sirona, USA

Group 3: Patients with vacuum-formed retainers

Hawley retainers DEVICE

Acrylic based hawley retainers

Also known as: Dentaurum Orthocryl, Ispringen, Germany

Group 4: Patients with hawley retainers

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men and women patients aged between 10-18 years who have completed orthodontic treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University Faculty of Dentistry

Aydin, Efeler, 09000, Turkey (Türkiye)

Location

Related Publications (6)

• Raghavan AS, Pottipalli Sathyanarayana H, Kailasam V, Padmanabhan S. Comparative evaluation of salivary bisphenol A levels in patients wearing vacuum-formed and Hawley retainers: An in-vivo study. Am J Orthod Dentofacial Orthop. 2017 Mar;151(3):471-476. doi: 10.1016/j.ajodo.2016.07.022.

  PMID: 28257731 RESULT

• Manoj MK, Ramakrishnan R, Babjee S, Nasim R. High-performance liquid chromatography analysis of salivary bisphenol A levels from light-cured and chemically cured orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):803-808. doi: 10.1016/j.ajodo.2018.02.008.

  PMID: 30477778 RESULT

• Eliades T, Voutsa D, Sifakakis I, Makou M, Katsaros C. Release of bisphenol-A from a light-cured adhesive bonded to lingual fixed retainers. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):192-5. doi: 10.1016/j.ajodo.2009.12.026.

  PMID: 21300247 RESULT

• Sasaki N, Okuda K, Kato T, Kakishima H, Okuma H, Abe K, Tachino H, Tuchida K, Kubono K. Salivary bisphenol-A levels detected by ELISA after restoration with composite resin. J Mater Sci Mater Med. 2005 Apr;16(4):297-300. doi: 10.1007/s10856-005-0627-8.

  PMID: 15803273 RESULT

• Kang YG, Kim JY, Kim J, Won PJ, Nam JH. Release of bisphenol A from resin composite used to bond orthodontic lingual retainers. Am J Orthod Dentofacial Orthop. 2011 Dec;140(6):779-89. doi: 10.1016/j.ajodo.2011.04.022.

  PMID: 22133942 RESULT

• Eliades T, Hiskia A, Eliades G, Athanasiou AE. Assessment of bisphenol-A release from orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2007 Jan;131(1):72-5. doi: 10.1016/j.ajodo.2006.08.013.

  PMID: 17208109 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: July 28, 2021
• Primary Completion: November 8, 2022
• Study Completion: December 4, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)