BruxismNCT04733573
Pressure Algometry Evaluation of Two Occlusal Splint Designs in Bruxism Management - RCT
A study testing Two different occlusal splints in people with Bruxism and Sleep Disorder, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy.. Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Outpatient Clinic of PUM in Szczecin, Poland. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Sleep Disorder
- What is being tested?
- Two different occlusal splints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 30 Jun 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- I. Nocturnal Bruxism according to International Classification of Sleep Disorders, Second Edition (ICSD-2).
- The patient reports or is aware of tooth-grinding sounds or tooth clenching during sleep.
- One or more of the following is present: a. Abnormal wear of teeth b. Jaw muscle discomfort, fatigue, or pain and jaw lock upon awakening. c. Masseter muscle hypertrophy upon voluntary forceful clenching.
- The jaw muscle activity is not better explained by another current sleep disorder, medical or neurological disorder, medication use, or substance use disorder.
- Additional questionnaire for detecting bruxers:
- Has anyone heard you grinding your teeth at night? Is your jaw ever fatigued or sore in the morning? Are your teeth or gums ever sore on awakening in the morning? Do you ever experience temporal headaches on awakening in the morning? Are you aware of grinding your teeth during the day? Are you ever aware of clenching your teeth during the day Can you imitate a sound of grinding using your teeth.
Who cannot join
- unrestored tooth losses
- patients wearing removable dentures of any kind
- psychiatric conditions undermining/preventing occlusal splint usage
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Chair and Depratment of Dental Prosthetics
Szczecin
Bartosz Dalewski, DMD, PhD
Kamila Szczuchniak, DMD
About this study
Official title: Pressure Algometry Evaluation of Two Occlusal Splint Designs in Bruxism Management - Randomized, Controlled Clinical Trial
During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy..
Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Outpatient Clinic of PUM in Szczecin, Poland. Patients aged 18-65 years with probable bruxism, yet requiring splint therapy will be included in the study.
Read the detailed description
During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy..
Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Outpatient Clinic of PUM in Szczecin, Poland. Patients aged 18-65 years with probable bruxism, yet requiring splint therapy will be included in the study. Probable bruxism will be diagnosed on the basis of the patient's history and examination as follows. Inclusion criteria:
- Nocturnal Bruxism according to International Classification of Sleep Disorders, Second Edition (ICSD-2).
- The patient reports or is aware of tooth-grinding sounds or tooth clenching during sleep.
- One or more of the following is present: a. Abnormal wear of teeth b. Jaw muscle discomfort, fatigue, or pain and jaw lock upon awakening. c. Masseter muscle hypertrophy upon voluntary forceful clenching.
- The jaw muscle activity is not better explained by another current sleep disorder, medical or neurological disorder, medication use, or substance use disorder.
II. Additional questionnaire for detecting bruxers:
- Has anyone heard you grinding your teeth at night?
- Is your jaw ever fatigued or sore in the morning?
- Are your teeth or gums ever sore on awakening in the morning?
- Do you ever experience temporal headaches on awakening in the morning?
- Are you aware of grinding your teeth during the day?
- Are you ever aware of clenching your teeth during the day
- Can you imitate a sound of grinding using your teeth.
III. Eligible patients will be randomly assigned into two groups. Sealed, opaque envelopes will be used for randomization. The first group will be treated with a stabilization appliance described by Okeson. The second group will undergo therapy with a two-jaw splint with an arch. Patients will be informed about how to use and maintain hygiene of the splint. It will be recommended to use a splint only while sleeping.
IV. Pressure pain threshold test (PPT) will be carried out at the Department of Prosthodontics of the Pomeranian Medical University, Szczecin, Poland using the Wagner Paintest FPX 25 algometer. Points within the following muscles will be examined:
masseter muscles, anterior, middle and posterior abdomens of the temporal muscles, a point at the height of the TMJ larger exterior convexity, the sternocleidomastoid muscles and the preauriculare point, bilaterally two measurements at each visit. The test will be performed at the first visit and after 30 days of therapy.
The algometer comes with a 1 cm2 rubber tip, which measures the pressure in kg / s while pressing on the tested surface. Both test results will be used as a pre- and post- treatment evaluation.
- Conditions
- Bruxism, Sleep Disorder
- Being tested
- Two different occlusal splints
- Keywords
- bruxism, algometer, pressure pain threshold, occlusal, splint, grinding, clenching
- Medical subject headings
- Bruxism, Sleep Wake Disorders, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two different occlusal splintsDevice
Two different occlusal splints will be used for bruxism management, PPT would be evaluated twice - before and after 30 days of splint therapy using pressure algometer (FPX25, Wagner Instruments, US)
| Study group | Role | What they receive |
|---|---|---|
| Occlusal appliance by Okeson with canone guidance | Active comparator | Occlusal appliance will be used while sleeping for 30 days. Receives: Device: Two different occlusal splints |
| Bimaxillary splint without canine guidance | Active comparator | Bimaxillary splint will be used while sleeping for 30 days. Receives: Device: Two different occlusal splints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold in designated points
Evaluation of difference between algometer readings before and after 30 days of splint usage - FPX25 algometer (Wagner instruments, US) will be used
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Jan 2021
- Primary completion16 Jun 2021
- Study completion30 Jun 2021 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalewski Bartosz, Pomeranian Medical University Szczecin
- Investigators
- Agata Kamińska, DMD, Principal investigator, Pomeranian Medical Universiy in Szczecin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733573
- Sponsor's protocol ID
- KB-0012/49/10
- Status last verified
- Jun 2021
- First submitted
- 26 Jan 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dalewski B, Kaminska A, Kiczmer P, Wegrzyn K, Palka L, Janda K, Sobolewska E. Pressure Algometry Evaluation of Two Occlusal Splint Designs in Bruxism Management-Randomized, Controlled Clinical Trial. J Clin Med. 2021 May 27;10(11):2342. doi: 10.3390/jcm10112342.
PubMed 34071832
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Algometry Evaluation of Two Occlusal Splint Designs in Bruxism Management - Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04733573
- Acronym / sponsor ID
- KB-0012/49/10
- Conditions
- Bruxism, Sleep Disorder
- Keywords
- bruxism, algometer, pressure pain threshold, occlusal, splint, grinding, clenching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 2 Feb 2021 (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.
During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy..
Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Outpatient Clinic of PUM in Szczecin, Poland. Patients aged 18-65 years with probable bruxism, yet requiring splint therapy will be included in the study.
Detailed description
During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy..
Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Outpatient Clinic of PUM in Szczecin, Poland. Patients aged 18-65 years with probable bruxism, yet requiring splint therapy will be included in the study. Probable bruxism will be diagnosed on the basis of the patient's history and examination as follows. Inclusion criteria:
- Nocturnal Bruxism according to International Classification of Sleep Disorders, Second Edition (ICSD-2).
- The patient reports or is aware of tooth-grinding sounds or tooth clenching during sleep.
- One or more of the following is present: a. Abnormal wear of teeth b. Jaw muscle discomfort, fatigue, or pain and jaw lock upon awakening. c. Masseter muscle hypertrophy upon voluntary forceful clenching.
- The jaw muscle activity is not better explained by another current sleep disorder, medical or neurological disorder, medication use, or substance use disorder.
II. Additional questionnaire for detecting bruxers:
- Has anyone heard you grinding your teeth at night?
- Is your jaw ever fatigued or sore in the morning?
- Are your teeth or gums ever sore on awakening in the morning?
- Do you ever experience temporal headaches on awakening in the morning?
- Are you aware of grinding your teeth during the day?
- Are you ever aware of clenching your teeth during the day
- Can you imitate a sound of grinding using your teeth.
III. Eligible patients will be randomly assigned into two groups. Sealed, opaque envelopes will be used for randomization. The first group will be treated with a stabilization appliance described by Okeson. The second group will undergo therapy with a two-jaw splint with an arch. Patients will be informed about how to use and maintain hygiene of the splint. It will be recommended to use a splint only while sleeping.
IV. Pressure pain threshold test (PPT) will be carried out at the Department of Prosthodontics of the Pomeranian Medical University, Szczecin, Poland using the Wagner Paintest FPX 25 algometer. Points within the following muscles will be examined:
masseter muscles, anterior, middle and posterior abdomens of the temporal muscles, a point at the height of the TMJ larger exterior convexity, the sternocleidomastoid muscles and the preauriculare point, bilaterally two measurements at each visit. The test will be performed at the first visit and after 30 days of therapy.
The algometer comes with a 1 cm2 rubber tip, which measures the pressure in kg / s while pressing on the tested surface. Both test results will be used as a pre- and post- treatment evaluation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusal appliance by Okeson with canone guidance | Active comparator | Device: Two different occlusal splintsOcclusal appliance will be used while sleeping for 30 days. |
| Bimaxillary splint without canine guidance | Active comparator | Device: Two different occlusal splintsBimaxillary splint will be used while sleeping for 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- I. Nocturnal Bruxism according to International Classification of Sleep Disorders, Second Edition (ICSD-2).
- The patient reports or is aware of tooth-grinding sounds or tooth clenching during sleep.
- One or more of the following is present: a. Abnormal wear of teeth b. Jaw muscle discomfort, fatigue, or pain and jaw lock upon awakening. c. Masseter muscle hypertrophy upon voluntary forceful clenching.
- The jaw muscle activity is not better explained by another current sleep disorder, medical or neurological disorder, medication use, or substance use disorder.
- Additional questionnaire for detecting bruxers:
Key exclusion criteria (3 listed)
- unrestored tooth losses
- patients wearing removable dentures of any kind
- psychiatric conditions undermining/preventing occlusal splint usage
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 |
|---|---|---|
| Two different occlusal splintsTwo different occlusal splints will be used for bruxism management, PPT would be evaluated twice - before and after 30 days of splint therapy using pressure algometer (FPX25, Wagner Instruments, US) | Device | Bimaxillary splint without canine guidance, Occlusal appliance by Okeson with canone guidance |
Primary outcome
Pressure pain threshold in designated points
Time frame: 30 days
Evaluation of difference between algometer readings before and after 30 days of splint usage - FPX25 algometer (Wagner instruments, US) will be used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Background: PubMed 34071832Dalewski B, Kaminska A, Kiczmer P, Wegrzyn K, Palka L, Janda K, Sobolewska E. Pressure Algometry Evaluation of Two Occlusal Splint Designs in Bruxism Management-Randomized, Controlled Clinical Trial. J Clin Med. 2021 May 27;10(11):2342. doi: 10.3390/jcm10112342.
- https://www.mdpi.com/2077-0383/10/11/2342Link provided by the sponsor.
- 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.
Agata Kamińska, DMD principal investigator
Pomeranian Medical Universiy in Szczecin, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two different occlusal splints in people with Bruxism and Sleep Disorder, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 6 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: status not confirmed, as of the sponsor's last update on 22 Jun 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 Poland. 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 Bartosz Dalewski, DMD, PhD (0048 914661717, bartosz.dalewski@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold in designated points (time frame: 30 days). 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 NCT04733573, 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 22 Jun 2021.