NCT06457646

Brief Summary

The goal of this observational study is to learn about the genetic factors influencing bruxism, a condition characterized by teeth grinding, in a group of participants. The main questions it aims to answer are:

  • Is there a significant association between the rs6313 polymorphism of the HTR2A gene and bruxism?
  • Is there a significant association between the rs6280 polymorphism of the DRD3 gene and bruxism? Participants will: Provide DNA samples for genotyping of the DRD3 (rs6280) and HTR2A (rs6313) polymorphisms. Provide RNA samples to assess changes in the expression of HTR2A and DRD3. Researchers will compare the genetic data and RNA expression levels between individuals with bruxism and those without (controls) to see if there are significant genetic differences and expression changes associated with bruxism.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 2, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 1, 2024

Last Update Submit

June 8, 2024

Conditions

Keywords

Gene ExpressionBruxismSleep bruxismPolymorphismGenetic

Outcome Measures

Primary Outcomes (1)

  • PCR-RFLP Analysis

    1 year

Interventions

The biological significance of HTR2A and DRD3 in bruxism remains unclear as molecular analyses, including genetic association studies, have not explored the mRNA expression of genes implicated in bruxism. This study aims to evaluate the influence of genetic polymorphisms affecting DRD3 (rs6280) and HTR2A (rs6313) on bruxism to identify potentially associated genotypes. Additionally, it aims to investigate the expression of HTR2A and DRD3 to elucidate their biological significance in bruxism.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 170 participants will be included in this study.

You may qualify if:

  • be above 18 years of age and have a confirmed diagnosis of bruxism

You may not qualify if:

  • Systemic diseases,
  • orofacial dysfunction,
  • acute symptoms such as neurodegenerative diseases (specifically Parkinsons disease),
  • Taking medication such as anxiolytics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wieckiewicz M, Bogunia-Kubik K, Mazur G, Danel D, Smardz J, Wojakowska A, Poreba R, Dratwa M, Chaszczewska-Markowska M, Winocur E, Emodi-Perlman A, Martynowicz H. Genetic basis of sleep bruxism and sleep apnea-response to a medical puzzle. Sci Rep. 2020 May 4;10(1):7497. doi: 10.1038/s41598-020-64615-y.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

BruxismSleep Bruxism

Interventions

Polymorphism, Genetic

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Genetic VariationGenetic Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2024

First Posted

June 13, 2024

Study Start

June 2, 2024

Primary Completion

December 15, 2024

Study Completion

December 17, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share