BruxismNCT04396171
Association of Probable Bruxism With Periodontal Status
An observational study of Bruxism, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status.The age, gender, education level, tooth loss, presence of probable bruxism and periodontal status of patients were evaluated. Read more about this study
- Who is it for?
- Ages 18 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- How many people
- 541 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2019to 10 Feb 2020
- 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 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients who applied to Department of Periodontology, Baskent University were included into the study.
Who may be able to join
- Patients with 18 years and older
Who cannot join
- age under 18 years,
- edentulous patients,
- not interested to participate in this study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University,Department of Dentistry
Ankara
About this study
Official title: Association of Probable Bruxism With Periodontal Status: A Cross Sectional Study
This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status.The age, gender, education level, tooth loss, presence of probable bruxism and periodontal status of patients were evaluated. Periodontal statuses of the participants were defined according to the American Association of Periodontology/European Federation of Periodontology, 2017 consensus and assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism.
Read the detailed description
This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status dental examination, all participants completed a standardized questionnaire. Sociodemographic findings comprised age, gender and educational level. Periodontal statuses of the participants were defined according to the American Association of Periodontology/European Federation of Periodontology, 2017 consensus. Participants were diagnosed with periodontitis if interdental clinical attachment loss (AL) was detected at ≥2 non-adjacent teeth, or buccal or oral AL was ≥3 mm with probing depth >3 mm was detected at ≥2 teeth. 12 In addition number of missing teeth is recorded.Assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism.Presence of masticatory muscle hypertrophy, temporomandibular joint pain, indentations on the tongue or lip and/or a linea alba on the inner cheek, damage to the dental hard tissues (eg, cracked teeth), mechanical wear of the teeth (ie, attrition), repetive failures of restorative work/prosthodontics constructions were examined in clinical evaluation.
- Conditions
- Bruxism
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Probable bruxism(+) | Not described | |
| Probable bruxism(-) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
probable bruxism
Assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism. For this purpose clinical inspection, one of the non-instrumental approaches, was used to evaluate the clinical features of bruxism. Presence of masticatory muscle hypertrophy, temporomandibular joint pain, indentations on the tongue or lip and/or a linea alba on the inner cheek, damage to the dental hard tissues (eg, cracked teeth), mechanical wear of the teeth (ie, attrition), repetive failures of restorative work/prosthodontics constructions were examined in clinical evaluation.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start10 Mar 2019
- Primary completion20 Jan 2020
- Study completion10 Feb 2020
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Bilgin Çetin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396171
- Sponsor's protocol ID
- MBCetin
- Status last verified
- May 2020
- First submitted
- 16 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Probable Bruxism With Periodontal Status: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04396171
- Acronym / sponsor ID
- MBCetin
- Conditions
- Bruxism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 20 May 2020 (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.
This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status.The age, gender, education level, tooth loss, presence of probable bruxism and periodontal status of patients were evaluated. Periodontal statuses of the participants were defined according to the American Association of Periodontology/European Federation of Periodontology, 2017 consensus and assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism.
Detailed description
This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status dental examination, all participants completed a standardized questionnaire. Sociodemographic findings comprised age, gender and educational level. Periodontal statuses of the participants were defined according to the American Association of Periodontology/European Federation of Periodontology, 2017 consensus. Participants were diagnosed with periodontitis if interdental clinical attachment loss (AL) was detected at ≥2 non-adjacent teeth, or buccal or oral AL was ≥3 mm with probing depth >3 mm was detected at ≥2 teeth. 12 In addition number of missing teeth is recorded.Assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism.Presence of masticatory muscle hypertrophy, temporomandibular joint pain, indentations on the tongue or lip and/or a linea alba on the inner cheek, damage to the dental hard tissues (eg, cracked teeth), mechanical wear of the teeth (ie, attrition), repetive failures of restorative work/prosthodontics constructions were examined in clinical evaluation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probable bruxism(+) | – | – |
| Probable bruxism(-) | – | – |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who applied to Department of Periodontology, Baskent University were included into the study.
Key inclusion criteria (1 listed)
- Patients with 18 years and older
Key exclusion criteria (3 listed)
- age under 18 years,
- edentulous patients,
- not interested to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
probable bruxism
Time frame: 5 minutes
Assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism. For this purpose clinical inspection, one of the non-instrumental approaches, was used to evaluate the clinical features of bruxism. Presence of masticatory muscle hypertrophy, temporomandibular joint pain, indentations on the tongue or lip and/or a linea alba on the inner cheek, damage to the dental hard tissues (eg, cracked teeth), mechanical wear of the teeth (ie, attrition), repetive failures of restorative work/prosthodontics constructions were examined in clinical evaluation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 20 May 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
probable bruxism (time frame: 5 minutes). 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 20 May 2020.