NCT06289608

Brief Summary

The aim of this study was o determine the relationship between self-reported bruxism (SB) and some psychological factors (i.e: Anxiety State-Trait; Stress Reactivity Index, Beck Depression Inventory). A consecutive sample of 101 patients that reported at least 2 of the 6 items of Bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

February 21, 2024

Last Update Submit

February 28, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Depression Level

    Beck Depression Index. The score range between 0-63, being proprotional to the current depression level

    baseline

  • Stress Level

    Stress Reactitivy Index: Each of the 32 items are coded in a 4-point likert scale format, being 4 the worst category. The summary score is a proportional estimation of the stress level and range from 0-0.5 (minor stress), 0.6-1 (moderate stress) and \>1 (severe stress)

    baseline

  • Anxiety

    State-Trait Inventory has two estimation of anxiety, as a trait (assessed by 26 items) and as a transitory state (assessed by 20 items). All the items are coded in a 0-3 likert scale. The total score is proportional to the anxiety, being the threshold for determining anxiety above 20 points in male and 25 in females.

    baseline

Study Arms (1)

Self-reported Bruxism

Those dental patients responding positively to at least 2 of the 6 items of the Pintado et al Self-reported Bruxism Inventory

Other: No intervention

Interventions

No dental intervention was made. Only a clinical examination

Self-reported Bruxism

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Self-reported bruxists

You may qualify if:

  • Self-reported Bruxism

You may not qualify if:

  • Refused patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Odontológica de la Universidad de Salamanca

Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

BruxismMuscular Disorders, AtrophicTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesCraniomandibular DisordersMandibular DiseasesJaw DiseasesJoint Diseases

Central Study Contacts

JAVIER MONTERO, PRF

CONTACT

Departamento Cirugía

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 4, 2024

Study Start

February 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 4, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

The aggregated data will be published in a paper of the JCR Dentistry group

Locations