Endocrine Disruptors in Saliva Released From Bruxism Splints.

NCT06088238 | Unknown DMC

• 1 other identifier: 23.282
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The effects of endocrine disruptors (EDs) are well known. Therefore, the aim of this observational study is to analyse saliva samples from volunteers who request a bruxism splint, before, during and after fitting, to find out whether they are assimilated by the body, answering the following questions:

• Do Michigan-type splints release endocrine disruptors or substances of particular concern?
• In what concentration are they present in saliva? Participants will be asked to take saliva samples at different times over a period of 6 months. This will also be accompanied by the relevant clinical and oral history. A previous in vitro study is required, which is complemented by an in vivo study. The methodology is new in dentistry: super solvents which, combined with liquid chromatography coupled to a mass spectrometer (LC-HRMS), allows a wider range of substances to be detected, in a more ecological and simpler way, as they are not organic solvents derived from petroleum. The splint is chosen because it is an everyday treatment, which is increasingly in demand, especially after the pandemic. It is subdivided into two types, depending on the method of manufacture: injected and printed (more ecofriendly).

Conditions

Bruxism

Keywords

dental material; endocrine disruptor; substances of very high concern; saliva; occlusal splint; acrylic dental material

Outcome Measures

Primary Outcomes (2)

• Identification of endocrine disruptors (EDs) or substances of concern of very high concern (SVHC)in saliva released by Michigan type occlusal splints before, during and after their application.

  Treatment of samples by addition of hexanol and tetrahydrofuran. The solutions will be analysed by liquid chromatography coupled to a LC-HRMS mass spectrometer.

  6 months

• Quantification of endocrine disruptors or substances of very high concern (SVHC) in saliva released from Michigan type occlusal splints before, during and after application.

  LC-HRMS (Liquid chromatography-high resolution mass spectrometry). Maximum dose recommended by the FDA (Food and Drug Administration): 4 micrograms/kilo/day in adults.

  6 months

Secondary Outcomes (2)

• Identification of endocrine disruptors or substances of very high concern (SVHC) released from Michigan-type occlusal splints in vitro simulating oral environment and wear.

  1 month

• Quantification of endocrine disruptors (EDs) or substances of very high concern (SVHCs) released from Michigan-type occlusal splints simulating oral environment and wear and tear

  1 month

Other Outcomes (2)

• Relationship between concentrations of endocrine disruptors or substances of very high concern detected in vitro and in vivo

  1 month

• Differences in concentrations of endocrine disruptors or substances of very high concern released from injected and in vivo imprinted Michigan-type splints

  1 month

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female Male Other
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample will be obtained from patients who are registered in the database of the Polyclinic of the European University of Madrid, who request a Michigan type splint for the treatment of bruxism, made of acrylic, made in two of the usual ways: printed or injected, in accordance with the inclusion and exclusion criteria. As the samples were treated with an innovative methodology in the field of dentistry, such as super solvents, this is a pilot study in which two groups of 15 participants each were formed, depending on the manufacturing process of the splint: injected or printed, totalling 30 volunteers.

You may qualify if:

• To be of legal age
• Be able to attend Polyclinic for 6 months.
• Require an acrylic relaxation splint type Michigan
• Not be pregnant
• Not be breastfeeding

You may not qualify if:

• Be a minor
• Allergy to any type of plastic material, acrylic or resins for dental use.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead
• Universidad de Córdoba: collaborator
• Universidade da Coruña: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

SALIVA

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: October 18, 2023
• Study Start: June 20, 2024
• Primary Completion: September 20, 2024
• Study Completion: December 20, 2024
• Last Updated: March 15, 2024

Record last verified: 2023-06