BruxismNCT06289608
Bruxism and Underlying Psichological Factors
An observational study of Bruxism and Muscular Disorders, Atrophic, run by University of Salamanca at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Muscular Disorders, Atrophic, Temporomandibular Joint Disorders
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Self-reported bruxists
Who may be able to join
- Self-reported Bruxism
Who cannot join
- Refused patients
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinica Odontológica de la Universidad de Salamanca
Salamanca, 37007
JAVIER MONTERO, DDS, 619429971, javimont@usal.es
About this study
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.
Read the detailed 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.
- Being tested
- No intervention
- Medical subject headings
- Bruxism, Muscular Disorders, Atrophic, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No dental intervention was made. Only a clinical examination
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Level
Beck Depression Index. The score range between 0-63, being proprotional to the current depression level
Measured: 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)
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Feb 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289608
- Sponsor's protocol ID
- ID_2024
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The aggregated data will be published in a paper of the JCR Dentistry group
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bruxism and Underlying Psichological Factors
- ClinicalTrials.gov ID
- NCT06289608
- Acronym / sponsor ID
- ID_2024
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-reported Bruxism | – | Other: No interventionThose dental patients responding positively to at least 2 of the 6 items of the Pintado et al Self-reported Bruxism Inventory |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Self-reported bruxists
Key inclusion criteria (1 listed)
- Self-reported Bruxism
Key exclusion criteria (1 listed)
- Refused patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo dental intervention was made. Only a clinical examination | Other | Self-reported Bruxism |
Primary outcome
Depression Level
Time frame: baseline
Beck Depression Index. The score range between 0-63, being proprotional to the current depression level
Stress Level
Time frame: baseline
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)
Anxiety
Time frame: baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No. The aggregated data will be published in a paper of the JCR Dentistry group
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Bruxism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism and Muscular Disorders, Atrophic, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JAVIER MONTERO, PRF (+34 619429971, javimont@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Level (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.