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Not yet recruitingNCT06457646Updated Jun 13, 2024

mRNA Expression and Genetic Polymorphisms Affecting DRD3 (rs6280) and HTR2A (rs6313) in Bruxism

An observational study in Bruxism, sponsored by University of Monastir. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by University of Monastir · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
169
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bruxism

Keywords

  • Gene Expression
  • Bruxism
  • Sleep bruxism
  • Polymorphism
  • Genetic
03

In context

Bruxism

151 studies on the registry are indexed under Bruxism; 39 are open to participants now.

This study's planned enrollment of 169 is above the median of 89 across 55 observational studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Systemic diseases,
  • orofacial dysfunction,
  • acute symptoms such as neurodegenerative diseases (specifically Parkinsons disease),
  • Taking medication such as anxiolytics
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
169 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • GeneticGenetic polymorphism

    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.

06

What researchers measure

Primary outcomes

  1. PCR-RFLP Analysis

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32367059 ↗

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2024; primary completion for Dec 2024, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2024
First posted
Jun 13, 2024
StartEst.
Jun 2, 2024
Primary completionEst.
Dec 15, 2024
CompletionEst.
Dec 17, 2024
Last update
Jun 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06457646
Responsible party
Yosra Gassara (Principal Investigator, University of Monastir) — Principal investigator
First posted
Jun 13, 2024
Start date
Jun 2, 2024 (estimated)
Primary completion
Dec 15, 2024 (estimated)
Completion
Dec 17, 2024 (estimated)
Last update
Jun 13, 2024

Study contacts

Yosra Gassara
Contact
chouchengassarayosra@gmail.com
216-587-5455 ext. +216 55374741

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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