Sleep Bruxism, AdultbruxismNCT04934449
Occlusal Splints in the Treatment of Sleep Bruxism
A study testing Occlusal splint in people with Sleep Bruxism, Adult and Splints, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms according to the used material. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Bruxism, Adult, Splints, Sleep
- What is being tested?
- Occlusal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Aug 2021to 14 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy participants with complete permanent dentition.
Who cannot join
- Presence of a systemic disorder that could compromise the masticatory system (e.g., neurological disorders, epilepsy, cerebral palsy, among others),
- Systemic disorder or current use of drugs that could interfere, directly or indirectly, with muscle activity,
- Inappropriate behavior and/or refusal to cooperate with dental procedures and data collection,
- Tooth loss (except for third molars),
- Soft tissue abnormalities,
- Toothache report,
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- Active periodontitis (presence of periodontal pockets involvement of the supporting tissues),
- Caries lesions,
- Use of orthodontic appliances,
- Use of dental prosthesis (fixed or removable partial).
- Subjects with moderate to severe malocclusions, diagnosed by using the Orthodontic Treatment Need Index (IOTN) (scores 5 or 6 - severe and extreme need for orthodontic treatment)
- Alcohol or drug abuse,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul university,Faculty of Dentistry
Fatih, 34452
About this study
Official title: The Effect of Occlusal Splint Type on Sleep Quality and Occlusal Force in Patients With Sleep Bruxism
Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms according to the used material.
In this study, it was aimed to evaluate the effect of occlusal splint type on the sleep quality and occlusal force parameters of patients with sleep bruxism.
Read the detailed description
Various splint designs have been used for the treatment of sleep bruxism that is made up of different materials: Hard and soft splints. Although, these splints have slightly different appearances and properties, in fact, scientific evidence supports both the use of hard and soft occlusal splints. Hard splints are more preferred when compared to soft ones, thus, oft appliances have been less documented in the scientific literature. However, some studies suggested the use of soft-resin splints that are easily fabricated and may be inserted at an initial appointment, dental clinicians may desire the use of soft appliances. One of the advantages of these appliances is they are easy to tolerable to the patient and comfortable. Additionally, these splints fit tightly and provide a flat plane during sleep.
Considering these advantages, the present study was designed to examine the effect of the use of different types of occlusal splints on the sleep quality and occlusal force of patients with sleep bruxism. For this purpose, the effect of two splints basically fabricated from two different materials were evaluated and compared. The null hypothesis was that the use of both occlusal splints would not change the values of sleep quality and maximum occlusal force of the patients with sleep bruxism.
- Conditions
- Sleep Bruxism, Adult, Splints, Sleep
- Being tested
- Occlusal splint
- Keywords
- sleep quality, occlusal splint, bruxism
- Medical subject headings
- Sleep Bruxism, Sleep Initiation and Maintenance Disorders, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal splintDevice
Using occlusal splints during sleep for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Hard splint group- 2 mm thicknesss | Experimental | This group of patients was allocated to use 2 mm-thickness, hard occlusal splints for 2 months during sleep Receives: Device: Occlusal splint |
| Hard splint group- 3 mm thicknesss | Experimental | This group of patients was allocated to use 3 mm-thickness, hard occlusal splints for 2 months during sleep Receives: Device: Occlusal splint |
| Soft splint group- 2 mm thicknesss | Experimental | This group of patients was allocated to use 2 mm-thickness, soft occlusal splints for 2 months during sleep Receives: Device: Occlusal splint |
| Soft splint group- 3 mm thicknesss | Experimental | This group of patients was allocated to use 3 mm-thickness, soft occlusal splints for 2 months during sleep Receives: Device: Occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Evaluating sleep quality with Pittsburgh sleep quality index
Measured: 2 months
occlusal force
Measuring maximum occlusal force by using digital gnatodynanometer
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start6 Aug 2021
- Primary completion12 Dec 2021
- Study completion14 Dec 2021
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 Bruxism, AdultStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Merve Benli, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934449
- Sponsor's protocol ID
- 1299
- Acronym
- bruxism
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosar JV, Barbosa TS, Dias IOV, Kobayashi FY, Costa YM, Gaviao MBD, Bonjardim LR, Castelo PM. Effect of interocclusal appliance on bite force, sleep quality, salivary cortisol levels and signs and symptoms of temporomandibular dysfunction in adults with sleep bruxism. Arch Oral Biol. 2017 Oct;82:62-70. doi: 10.1016/j.archoralbio.2017.05.018. Epub 2017 May 27.
PubMed 28601734
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Occlusal Splint Type on Sleep Quality and Occlusal Force in Patients With Sleep Bruxism
- ClinicalTrials.gov ID
- NCT04934449
- Acronym / sponsor ID
- bruxism / 1299
- Conditions
- Sleep Bruxism, Adult, Splints, Sleep
- Keywords
- sleep quality, occlusal splint, bruxism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 22 Jun 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.
Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms according to the used material.
In this study, it was aimed to evaluate the effect of occlusal splint type on the sleep quality and occlusal force parameters of patients with sleep bruxism.
Detailed description
Various splint designs have been used for the treatment of sleep bruxism that is made up of different materials: Hard and soft splints. Although, these splints have slightly different appearances and properties, in fact, scientific evidence supports both the use of hard and soft occlusal splints. Hard splints are more preferred when compared to soft ones, thus, oft appliances have been less documented in the scientific literature. However, some studies suggested the use of soft-resin splints that are easily fabricated and may be inserted at an initial appointment, dental clinicians may desire the use of soft appliances. One of the advantages of these appliances is they are easy to tolerable to the patient and comfortable. Additionally, these splints fit tightly and provide a flat plane during sleep.
Considering these advantages, the present study was designed to examine the effect of the use of different types of occlusal splints on the sleep quality and occlusal force of patients with sleep bruxism. For this purpose, the effect of two splints basically fabricated from two different materials were evaluated and compared. The null hypothesis was that the use of both occlusal splints would not change the values of sleep quality and maximum occlusal force of the patients with sleep bruxism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hard splint group- 2 mm thicknesss | Experimental | Device: Occlusal splintThis group of patients was allocated to use 2 mm-thickness, hard occlusal splints for 2 months during sleep |
| Hard splint group- 3 mm thicknesss | Experimental | Device: Occlusal splintThis group of patients was allocated to use 3 mm-thickness, hard occlusal splints for 2 months during sleep |
| Soft splint group- 2 mm thicknesss | Experimental | Device: Occlusal splintThis group of patients was allocated to use 2 mm-thickness, soft occlusal splints for 2 months during sleep |
| Soft splint group- 3 mm thicknesss | Experimental | Device: Occlusal splintThis group of patients was allocated to use 3 mm-thickness, soft occlusal splints for 2 months during sleep |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy participants with complete permanent dentition.
Key exclusion criteria (12 listed)
- Presence of a systemic disorder that could compromise the masticatory system (e.g., neurological disorders, epilepsy, cerebral palsy, among others),
- Systemic disorder or current use of drugs that could interfere, directly or indirectly, with muscle activity,
- Inappropriate behavior and/or refusal to cooperate with dental procedures and data collection,
- Tooth loss (except for third molars),
- Soft tissue abnormalities,
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 |
|---|---|---|
| Occlusal splintUsing occlusal splints during sleep for 2 months | Device | Hard splint group- 2 mm thicknesss, Hard splint group- 3 mm thicknesss, Soft splint group- 2 mm thicknesss, Soft splint group- 3 mm thicknesss |
Primary outcome
Sleep quality
Time frame: 2 months
Evaluating sleep quality with Pittsburgh sleep quality index
occlusal force
Time frame: 2 months
Measuring maximum occlusal force by using digital gnatodynanometer
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 22 Jun 2022.
- Background: PubMed 28601734Rosar JV, Barbosa TS, Dias IOV, Kobayashi FY, Costa YM, Gaviao MBD, Bonjardim LR, Castelo PM. Effect of interocclusal appliance on bite force, sleep quality, salivary cortisol levels and signs and symptoms of temporomandibular dysfunction in adults with sleep bruxism. Arch Oral Biol. 2017 Oct;82:62-70. doi: 10.1016/j.archoralbio.2017.05.018. Epub 2017 May 27.
- 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.
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?
A study testing Occlusal splint in people with Sleep Bruxism, Adult and Splints, run by Istanbul 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 12 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 22 Jun 2022. 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?
Sleep quality (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT04934449, 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 2022.