Clinical trial NCT05738889: Comparative Evaluation of Salivary Bisphenol-A Levels in Patients With Fixed Lingual, Hawley and Vacuum-formed Retainers
Official title: Comparative Evaluation of Salivary Bisphenol-A Levels in Patients With Fixed Lingual, Hawley and Vacuum-formed Retainers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthodontic Retention
Keywords: Orthodontic retention
Bisphenol-A
lingual retainer
Hawley retainer
Vacuum formed retainer
essix plate
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women patients aged between 10-18 years who have completed orthodontic treatment

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bisphenol-A amount in saliva before applying a retainer with bis-GMA-containing composite
timeFrame: 1 day after debonding and before retention appliance to 1 month.
measure: Bisphenol-A amount in saliva before applying a retainer with bis-GMA-free composite
timeFrame: 1 day after debonding and before retention appliance to 1 month.
measure: Bisphenol-A amount in saliva before applying vacuum formed retainer
timeFrame: 1 day after debonding and before retention appliance to 1 month.
measure: Bisphenol-A amount in saliva before applying hawley retainer
timeFrame: 1 day after debonding and before retention appliance to 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University Faculty of Dentistry
state: Efeler
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.