Sleep BruxismDIABRUXNCT03325920
Validation of a Diagnostic Method for Quantification of Sleep Bruxism
A study testing DIABRUX in people with Sleep Bruxism and Diagnosis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This study aims to validate a new diagnostic method for quantification and monitoring of sleep bruxism. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism, Diagnosis
- What is being tested?
- DIABRUX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 20 May 2019to 31 Jul 2020
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient has signed and understood the approved informed consent form and is able to meet the proposed study proceedings
- for the sleep bruxism Group: subjects have to fulfill the clinical criteria of the American Academy of Sleep Medicine (sleeping partner's Report of grinding sounds during sleep within the last 6 months, plus at least one of the following symptoms: abnormal attrition of the teeth or shiny spots on dental restorations, hypertrophy of the masseteric muscle upon palpation, and/or self-report of muscle fatigue on awakening. In addition to the clinical criteria for sleep bruxism diagnosis, the following polysomnographic criteria have to be present: bruxism episodes/hr >4, bruxism burst/hr >25, at least one episode of grinding per sleep period
- Subjects that do not meet any of the clinical or polysomnographic criteria for sleep bruxism were included into the non-sleep bruxism group.
Who cannot join
- current participation in another interventional Investigation
- cardiac Pacemaker
- central nervous system and peripheral nervous system disorders
- use of sedating medications and/or psychopharmacologically effective drugs
- suspected severe psychological disorder (for example schizophrenia)
- a lack of German language
Show all 17Show fewer
- drug and/or alcohol abuse
- pregnancy or breast-feeding
- Participants of the sleep bruxism group that do not meet any of the clinical or polysomnographic criteria for sleep bruxism were excluded from the sleep bruxism group.
- Participants of the non-sleep bruxism group that fulfill the clinical and/or polysomnographic criteria for sleep bruxism were excluded from the non-sleep bruxism group.
- Further dental exclusion criteria are:
- prostheses or extensive prosthetic restorations
- dental functional treatment during the last 6 months
- gross malocclusion
- too many missing teeth that omit fabricating a diagnostic plate
- fixed brace
- temporomandibular dysfunction requiring treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Poliklinik für Zahnerhaltung, Parodontologie und Endodontologie Universitätsklinikum der Heinrich-Heine- Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Validation of a Diagnostic Method for Quantification and Monitoring of Sleep Bruxism
This study aims to validate a new diagnostic method for quantification and monitoring of sleep bruxism.
Read the detailed description
Sleep bruxism has characteristically been defined by the American Academy of Sleep Medicine as 'an oral activity characterized by grinding or clenching of the teeth during sleep, usually associated with sleep arousals'. For sleep bruxism diagnosis, to date the polysomnographic recordings represent the highest standard for sleep bruxism diagnosis, but they are concomitantly associated with disadvantages which include technical complexity, limited availability, and the fact that they are time-consuming and cost-intensive. Recently, a prototype of a diagnostic plate has been developed which allows a fully-automatic, computer-based quantification of abrasion thereupon for the assessment of sleep bruxism activity. The results of the pilot study were promising, and therefore, the aim of the present study is to refine and validate this new diagnostic method for quantification and monitoring of sleep bruxism.
- Conditions
- Sleep Bruxism, Diagnosis
- Being tested
- DIABRUX
- Keywords
- sleep bruxism, diagnosis, validation study, assessment
- Medical subject headings
- Sleep Bruxism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIABRUXDevice
Also called Diagnostic plate
All participants receive an individually fabricated diagnostic plate, viz the DIABRUX, for the upper or lower jaw to be worn for five consecutive nights. After use a newly developed analyzing software quantifies the abrasion on the diagnostic plate, thus resulting in a score, viz the Pixel score. This represents a quantitative measure of sleep bruxism activity.
| Study group | Role | What they receive |
|---|---|---|
| Sleep bruxism group | Experimental | 25 sleep bruxism subjects wear the DIABRUX for five consecutive nights. Receives: Device: DIABRUX |
| non-sleep bruxism group | Experimental | 25 non-sleep bruxism subjects wear the DIABRUX for five consecutive nights. Receives: Device: DIABRUX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pixel score of the diagnostic plate
Quantitative measure of sleep bruxism activity
Measured: The DIABRUX plate should be worn for five consecutive nights. This will be performed by each participant at the earliest of the 12th and not later than the 85th days after screening.
Secondary outcomes (7)
Psychologic load
Psychologic load will be estimated by means of the Symptom-Check-List-90 Standard (SCL-90-S; Franke, 1995) measuring subjective complaints, as well as physical and mental impairments. This self-assessment questionnaire implies 90 items with a total of 9 different scales: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism and seven supplementary questions. Every item starts with "For the past week, how much were you bothered by" followed by 90 different symptoms. The items are Likert scaled with a range from 0 ("not at all") to 4 ("extremely"), whereby higher values represent a higher psychological load. Three global indices are reported via the SCL-90-S, viz. the Global Severity Index (GSI), the Positive Symptom Total (PST), and the Positive Symptom Distress Index (PSDI). The higher the score of each index, the greater is the psychological load.
Measured: Subjects who fulfill the inclusion criteria and none of the exclusion criteria should stipulate the first visit not later than 28 days after screening (day 0).
Oral health-related quality of life
Oral health-related quality of life will be recorded with the Oral Health Impact Profile German 14 (OHIP-G14; Slade, 1997). The OHIP-G14 measures the subjective experience in terms of oral health (teeth, mouth, jaw and denture). It contains 14 questions (e.g. "Have you had painful aching in your mouth?") which are Likert scaled from 0 ("never") to 4 ("very often"). All questions refer to the last month. There are 7 different dimensions with two questions each (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap). Values can be summed up to a total score, ranging between 0 and 56. Higher scores represent a more negative experience with one's oral health.
Measured: Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.
Pain perception
Pain perception will be calculated using the pain perception scale (Schmerzempfindungsskala, SES; Geissner, 1996). The SES is a self-assessment questionnaire for describing the subjective pain perception. It consists of two parts (part A with 14 items and part B with 10 item) which form two global scales: A = affective pain perception and B = sensoric pain perception. Every single item is based on adjective sentences like "I feel my pain is burning". Items are Likert scaled with a range from 1 ("this is not true") to 4 ("this is exactly true"). Higher values correspond to a painfully experience and represent a worse outcome. Item values are summed for every scale, therefore the scale range A is from 14 to 56 and the scale range B is from 10 to 40. Raw scale values can be transferred into the percent range.
Measured: Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.
Dream experience
Aspects of dream experience will be assessed using the Mannheim Dream Questionnaire (MADRE; Schredl et al., 2014) combined with a dream protocol. These include dream recall, dream types, attitude towards dreaming, what dreamers do with their dreams, and effects of dreaming on waking life. Every item measures a single aspect of dreaming and the response format gathers information about frequencies (e.g. "every morning" or "less than once a month") and contents (e.g. topics of nightmares in childhood). Scaling of the items varies between 3 to 8 points and they range between 0 (least degree of manifestation/frequency) and maximum 8 (highest degree of manifestation/frequency). No global score exists. There is one aggregate score concerning attitude towards dreams, that encompasses 6 items with a 5-point Likert scale (0 = "not at all" to 4 "totally"), e.g. "I think that dreaming is in general a very interesting phenomenon."
Measured: Recorded during the 2. and the 3. visit; this appointment may happen between the 2nd-57th day of study participation.
Individual stress coping
The stress coping questionnaire 78 (SVF-78; Janke et al., 1985) assesses individual long-term and constant strategies to cope with stress. The respondents determine by themselves how likely they apply 78 different coping styles. Coping styles refer to everyday situations. Every items starts with the phrase "If I was affected, disturbed or unsettled by someone or something", followed by a coping strategy (e.g. "I ask someone to help me"). Items are Likert scaled with a range from 0 ("not at all") to 4 ("very likely"). Higher values stand for a higher likelihood to apply the reaction in a certain situation. Two different main scales exist which sum up either positive strategies (adaptive strategies) or negative strategies (maladaptive strategies). Higher scores in positive strategies represent a stress reductive coping style. Higher scores in negative strategies represent a stress enhancing coping style. Raw values can be transferred to standardized T-scores.
Measured: Recorded during the 4. visit; this appointment may happen between the 5th-71th day of study participation.
State-trait-Anxiety
The State-Trait-Anxiety Inventory (STAI; Laux et al. 1981) consists of 2 questionnaires with 20 items, respectively, and provides 20 different statements to describe ones feelings of anxiety at the moment. Half of the statements contain anxiety-present (e.g. "I feel over-excited and rattled"), the other half anxiety-absent items (e.g. "I am relaxed"). 4-point Likert scales are used with values from 1 ("not at all") to 4 ("very much so"). The trait anxiety scale comprises 20 statements to describe feelings of anxiety in general. 13 statements involve anxiety-present (e.g. "I lack self-confidence") and 7 anxiety-absent items (e.g. "I feel secure"). 4-point Likert scales allow data indication with values from 1 ("almost never") to 4 ("almost always"). The range of values is between 20 and 40 for each scale. The higher the score the more intense is the feeling of anxiety or, in relation to trait anxiety, the heavier is the anxiety disorder.
Measured: Recorded during the 4. visit; this appointment may happen between the 5th-71th day of study participation.
Subjective rating of the DIABRUX characteristics
Subjective rating of the device characteristics will be evaluated by using a short questionnaire.
Measured: The short questionnaire should be returned to the site together with the used DIABRUX plate. This will be performed by each participant at the earliest of the 12th and not later than the 85th days after screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start20 May 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, national, double-blind, controlled clinical trial with parallel group design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle A Ommerborn, Dr., Principal investigator, Universitätsklinikum Düsseldorf/Heinrich-Heine-University Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325920
- Sponsor's protocol ID
- 2017094440
- Acronym
- DIABRUX
- Status last verified
- Mar 2021
- First submitted
- 22 Sep 2017
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ommerborn MA, Giraki M, Schneider C, Schaefer R, Gotter A, Franz M, Raab WH. A new analyzing method for quantification of abrasion on the Bruxcore device for sleep bruxism diagnosis. J Orofac Pain. 2005 Summer;19(3):232-8.
PubMed 16106717
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Diagnostic Method for Quantification and Monitoring of Sleep Bruxism
- ClinicalTrials.gov ID
- NCT03325920
- Acronym / sponsor ID
- DIABRUX / 2017094440
- Conditions
- Sleep Bruxism, Diagnosis
- Keywords
- sleep bruxism, diagnosis, validation study, assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 30 Oct 2017 (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 study aims to validate a new diagnostic method for quantification and monitoring of sleep bruxism.
Detailed description
Sleep bruxism has characteristically been defined by the American Academy of Sleep Medicine as 'an oral activity characterized by grinding or clenching of the teeth during sleep, usually associated with sleep arousals'. For sleep bruxism diagnosis, to date the polysomnographic recordings represent the highest standard for sleep bruxism diagnosis, but they are concomitantly associated with disadvantages which include technical complexity, limited availability, and the fact that they are time-consuming and cost-intensive. Recently, a prototype of a diagnostic plate has been developed which allows a fully-automatic, computer-based quantification of abrasion thereupon for the assessment of sleep bruxism activity. The results of the pilot study were promising, and therefore, the aim of the present study is to refine and validate this new diagnostic method for quantification and monitoring of sleep bruxism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, national, double-blind, controlled clinical trial with parallel group design
| Arm | Type | Receives |
|---|---|---|
| Sleep bruxism group | Experimental | Device: DIABRUX25 sleep bruxism subjects wear the DIABRUX for five consecutive nights. |
| non-sleep bruxism group | Experimental | Device: DIABRUX25 non-sleep bruxism subjects wear the DIABRUX for five consecutive nights. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient has signed and understood the approved informed consent form and is able to meet the proposed study proceedings
- for the sleep bruxism Group: subjects have to fulfill the clinical criteria of the American Academy of Sleep Medicine (sleeping partner's Report of grinding sounds during sleep within the last 6 months, plus at least one of the following symptoms: abnormal attrition of the teeth or shiny spots on dental restorations, hypertrophy of the masseteric muscle upon palpation, and/or self-report of muscle fatigue on awakening. In addition to the clinical criteria for sleep bruxism diagnosis, the following polysomnographic criteria have to be present: bruxism episodes/hr >4, bruxism burst/hr >25, at least one episode of grinding per sleep period
- Subjects that do not meet any of the clinical or polysomnographic criteria for sleep bruxism were included into the non-sleep bruxism group.
Key exclusion criteria (17 listed)
- current participation in another interventional Investigation
- cardiac Pacemaker
- central nervous system and peripheral nervous system disorders
- use of sedating medications and/or psychopharmacologically effective drugs
- suspected severe psychological disorder (for example schizophrenia)
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 |
|---|---|---|
| DIABRUXAlso: Diagnostic plateAll participants receive an individually fabricated diagnostic plate, viz the DIABRUX, for the upper or lower jaw to be worn for five consecutive nights. After use a newly developed analyzing software quantifies the abrasion on the diagnostic plate, thus resulting in a score, viz the Pixel score. This represents a quantitative measure of sleep bruxism activity. | Device | Sleep bruxism group, non-sleep bruxism group |
Primary outcome
Pixel score of the diagnostic plate
Time frame: The DIABRUX plate should be worn for five consecutive nights. This will be performed by each participant at the earliest of the 12th and not later than the 85th days after screening.
Quantitative measure of sleep bruxism activity
7 secondary outcomes
Psychologic load
Time frame: Subjects who fulfill the inclusion criteria and none of the exclusion criteria should stipulate the first visit not later than 28 days after screening (day 0).
Oral health-related quality of life
Time frame: Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.
Pain perception
Time frame: Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.
Dream experience
Time frame: Recorded during the 2. and the 3. visit; this appointment may happen between the 2nd-57th day of study participation.
Individual stress coping
Time frame: Recorded during the 4. visit; this appointment may happen between the 5th-71th day of study participation.
State-trait-Anxiety
Time frame: Recorded during the 4. visit; this appointment may happen between the 5th-71th day of study participation.
Subjective rating of the DIABRUX characteristics
Time frame: The short questionnaire should be returned to the site together with the used DIABRUX plate. This will be performed by each participant at the earliest of the 12th and not later than the 85th days after screening.
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 11 Mar 2021.
- Results publication: PubMed 16106717Ommerborn MA, Giraki M, Schneider C, Schaefer R, Gotter A, Franz M, Raab WH. A new analyzing method for quantification of abrasion on the Bruxcore device for sleep bruxism diagnosis. J Orofac Pain. 2005 Summer;19(3):232-8.
- Individual participant dataSharing planned: No
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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.
Michelle A Ommerborn, Dr. principal investigator
Universitätsklinikum Düsseldorf/Heinrich-Heine-University Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIABRUX in people with Sleep Bruxism and Diagnosis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 3 inclusion and 17 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 11 Mar 2021. 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 Germany. 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?
Pixel score of the diagnostic plate (time frame: The DIABRUX plate should be worn for five consecutive nights. This will be performed by each participant at the earliest of the 12th and not later than the 85th days after screening.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325920, which also lists 1 linked publication.
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 11 Mar 2021.