Evaluation of the Release of Monomers From Composite Bonding Resins in Orthodontics

NCT04459013 | Completed

• 1 other identifier: APHP200328
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

In recent decades, the field of public health has become increasingly interested in endocrine disruptors, and their effects on humans. Indeed, various scientific studies have highlighted an evolution in the frequency of pathologies due to these substances, affecting in particular the reproductive organs. Many concerns are expressed about the impact of these substances, present in the environment or in consumer products, on the hormonal system. Effects have been observed in animals in experimental studies, but the question of extrapolating these results to humans arises, especially for exposures at low doses. In orthodontics, the composite is the material of choice mainly for bonding fasteners, then bonding a compression wire. These composite materials contain many monomers. The polemics launched on Bisphenol A and the questions of our patients on the nature and toxicity of dental products oblige us to reflect on their harmfulness after their placement in the oral cavity. Many questions arise today about dental composites and their participation in the release of endocrine disruptors. Indeed, Bisphenol A is used in the manufacturing process of the monomers of orthodontic composites, as precursors of Bis-GMA and Bis-DMA. The objective of this study is to search for the presence of BPA, TEGDMA, BisGMA, BisDMA and UDMA monomers, and to carry out the samples and their analysis at different clinical times (at T0, after the removal of orthodontic attachments, after the placement of the compression, one hour later, one week later, one month later and 6 months later) and the comparison of this quantification to that without orthodontic restraint. Studies have been performed in vitro, but very little in vivo. In addition, these studies are only carried out on release at the time of installation, but few are interested in the continuation of the phenomenon over time and the deterioration of the composite. Although the short-term toxicity of BPA is low, its dangerousness lies in its potential endocrine disrupting effect and which can induce long-term chronic toxicity. Compounds such as TEGDMA, BisGMA, BisDMA and UDMA differ greatly in their volatility due to their different chemical structures as well as in their stability in saliva; Many methods have been developed to study each monomer individually or to study them simultaneously using different analytical techniques to determine their presence and to quantify them after their release from dental products. The analysis of the samples is carried out by liquid chromatography (HPLC).

Conditions

Dent Disease

Keywords

Bisphenol A; toxicity; Composite; orthodontic retainers; release; endocrine disruptors

Outcome Measures

Primary Outcomes (1)

• Changement of quantity of the Bisphenol A

  The main objective of this research is the quantification of the Bisphenol A monomer released during the placement of a mandibular orthodontic compression in order to raise awareness among professionals or without orthodontic restraint..

  before any medical procedure, and regularly after the medical procedure

Secondary Outcomes (2)

• Changement of quantity of the release of TEGDMA monomers; UDMA; BisGMA and BisDMA

  before any medical procedure, and regularly after the medical procedure

• Changement of those quantities in patients with mandibular orthodontic restraints with patients without restraints

  before any medical procedure, and regularly after the medical procedure

Study Arms (1)

Patient of the orthodontic consultation

Other: Salivary samples

Interventions

Salivary samples OTHER

The salivary samples will be collected at 5 defined times

Patient of the orthodontic consultation

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient of the orthodontic consultation consultant in the dentistry department of the Pitié Salpêtrière hospital,

You may qualify if:

• Patient of the orthodontic consultation consultant in the dentistry department of the Pitié Salpêtrière hospital,
• Information and collection of the non-opposition of the adult patient or representatives of the parental authority for minors
• Good dental hygiene at the discretion of the investigator
• Patient agreeing to be followed for 6 months
• Good written and oral comprehension of the French language
• case-specific:
• Age between 10 and 70 years inclusive,
• Patients undergoing orthodontic treatment (multi-attachment device) with planned debagging and requiring compression with bonded mandibular wire from canine to canine, and maxillary groove
• Specific to witnesses:
• Age between 18 and 70 inclusive
• Patients undergoing orthodontic treatment (multi-attachment appliance) with planned debridement without the need for a retainer

You may not qualify if:

• Under tutorship or curatorship
• Opposition of the minor patient
• Gingival inflammation
• Patients requiring maxillary bonded restraint
• Composite restoration in the mouth
• Carious lesions
• Smokers
• Patients with chronic pathologies and / or under medication
• Chronic exposure to Bisphenol A.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service Odontology, Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Dent Disease

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn Errors; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: July 7, 2020
• Study Start: June 3, 2020
• Primary Completion: October 30, 2020
• Study Completion: December 16, 2020
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)