Bruxism and Underlying Psichological Factors

Temporomandibular Joint Disorders Clinical Trial

Official title:

Bruxism and Underlying Psichological Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289608
• Other study ID #: ID_2024
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2023
• Source: University of Salamanca
• Contact: JAVIER MONTERO, PRF
• Phone: +34 619429971
• Email: javimont[@]usal.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The Bruxism Self-Reported Index was that reported by Pintado et al.

Pintado MR, Anderson GC, DeLong R, Douglas WH. Variation in tooth wear in young adults over a two-year period. J Prosthet Dent. 1997;77:313-320.

The muscular pain was assessed by the last version of the Research Diagnostic Criteria reported by the Schiffman et al in 2014

Schiffman E, et al ; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Self-reported Bruxism

Exclusion Criteria:

• Refused patients

Related Conditions & MeSH terms

• Bruxism
• Muscular Diseases
• Muscular Disorders, Atrophic
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• No intervention
No dental intervention was made. Only a clinical examination

Locations

Country	Name	City	State
Spain	Clinica Odontológica de la Universidad de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Level	Beck Depression Index. The score range between 0-63, being proprotional to the current depression level	baseline
Primary	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
Primary	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