BruxismNCT06893744
Effects of Different Occlusal Splints
A study testing occlusal splint in people with Bruxism and Bruxism, Sleep, run by Ankara University.
Trial summary
This study was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. Read more about this study
- Who is it for?
- Ages 18 to 42 years
- Conditions the study is for
- Bruxism, Bruxism, Sleep, Occlusal Splints
- 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
- 49 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2013to 15 Aug 2014
- 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 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient has a complaint of grinding/clenching during sleep
- One or more of the following occurs:
- abnormal wear of the teeth
- sounds associated with the bruxism
- jaw muscle discomfort
- No other medical or mental disorders that affecting masticatory muscles activity
Who cannot join
- Patients with missing at least 2 posterior teeth, except for the third molars
- Presence of Myofascial Pain Dysfunction (MPD)
- Presence of major neurological, psychiatric or motor disorders
- Patients using medications, influencing sleep or motor functions
- Patients with alcohol or drug addiction
- Patients ongoing any dental treatment
Show all 11Show fewer
- Patients using occlusal splint or exposing the treatment for TMJ disorders in the last 3 months.
- Patients with pregnancy
- Patients with cancer
- Patients with scheduled surgery operation
- Patients with pericoronitis or supraeruption of 3rd molar
About this study
Official title: Effects of Different Occlusal Splints on Joint Vibrations in Bruxers
This study was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. 16 patients were treated with soft splint (group 2), 17 patients were treated with hard splint (group 3) and left 16 patients were treated with semi-soft splint (group 4). Joint vibration records were made with JVA (Biopak system BioResearch , Inc., Milwaukee, WI) device during the opening and closing movements. The recordings were made before and after occlusal splint treatment for three months in patients with bruxism. The recordings of individuals in control group was made two times at three months intervals. Also clinical evaluation was made with questionnaire forms. The study was approved by the ethical committee and each subject gave informed consent.
Read the detailed description
It was demonstrated that occlusal splints are effectual on improving clinical symptoms and reducing patient complaints in patients with bruxism. However the effects of occlusal splints on joint vibrations are not fully elucidated. The aim of this study is to evaluate the effects of three different occlusal splints (soft, hard and semi-soft) on joint vibrations in patients with bruxism and to compare with asymptomatic individuals. And also clinical symptoms and patient complaints were evaluated with questionnaire forms.
This study was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. 16 patients were treated with soft splint (group 2), 17 patients were treated with hard splint (group 3) and left 16 patients were treated with semi-soft splint (group 4). Joint vibration records were made with JVA (Biopak system BioResearch , Inc., Milwaukee, WI) device during the opening and closing movements. The recordings were made before and after occlusal splint treatment for three months in patients with bruxism. The recordings of individuals in control group was made two times at three months intervals. Also clinical evaluation was made with questionnaire forms. The study was approved by the ethical committee and each subject gave informed consent.
There was no significant difference in joint vibration parameters between patients with bruxism and asymptomatic individuals before treatment (p>0.0063). Between the increase in soft group and reduction respectively in hard group and semi-soft group for total integral values variations, after treatment at the opening movement for left joint were statistically significant (p=0.005 and p<0.001). Total integral, i>300 Hz, i<300 Hz, Peak amplitude, Peak frequency values of patients with bruxism were observed to be higher than the value of asymptomatic individuals, allthough there was no statistical difference. After three different occlusal splint treatment, it was observed that there was clinically improvement in patient complaints.
- Conditions
- Bruxism, Bruxism, Sleep, Occlusal Splints
- Being tested
- occlusal splint
- Keywords
- Bruxism, Occlusal Splints, Bruxism, Sleep, TMJ
- Medical subject headings
- Bruxism, Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal splintDevice
| Study group | Role | What they receive |
|---|---|---|
| Soft Splint | Experimental | It is a type of occlusal splint using soft material. It was applied to bruxist patients in accordance with the study design (Group 2). Receives: Device: occlusal splint |
| Hard Splint | Experimental | It is a type of occlusal splint using hard material. It was applied to bruxist patients in accordance with the study design (Group 3). Receives: Device: occlusal splint |
| Semi-soft Splint | Experimental | It is a type of occlusal splint using semi-soft material. They cover the advantages of soft and hard occlusal splints. It was applied to bruxist patients in accordance with the study design (Group 4). Receives: Device: occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibration analysis resulting from the movement between temporomandibular joint surfaces with JVA (Joint Vibration Analysis) device
Joint vibration analysis resulting from the movement between temporomandibular joint surfaces was performed by using a Joint Vibration Analysis device (BioPAK (BioResearch, Inc., Milwaukee, WI). Joint vibration analysis parameters were evaluated after occlusal splint treatments in patients with bruxism for each arm.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start15 Jan 2013
- Primary completion15 Feb 2013
- Study completion15 Aug 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora Akat, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893744
- Sponsor's protocol ID
- 42/4
- Status last verified
- Dec 2012
- First submitted
- 17 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akat B, Akoren AC, Tamam E. Effects of Different Occlusal Splints on Joint Vibrations in Bruxers. Medicina (Kaunas). 2025 Jun 12;61(6):1083. doi: 10.3390/medicina61061083.
PubMed 40572771
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Occlusal Splints on Joint Vibrations in Bruxers
- ClinicalTrials.gov ID
- NCT06893744
- Acronym / sponsor ID
- 42/4
- Conditions
- Bruxism, Bruxism, Sleep, Occlusal Splints
- Keywords
- Bruxism, Occlusal Splints, Bruxism, Sleep, TMJ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Jan 2013 (actual)
- Primary completion
- 15 Feb 2013 (actual)
- Study completion
- 15 Aug 2014 (actual)
- First posted
- 25 Mar 2025 (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 was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. 16 patients were treated with soft splint (group 2), 17 patients were treated with hard splint (group 3) and left 16 patients were treated with semi-soft splint (group 4). Joint vibration records were made with JVA (Biopak system BioResearch , Inc., Milwaukee, WI) device during the opening and closing movements. The recordings were made before and after occlusal splint treatment for three months in patients with bruxism. The recordings of individuals in control group was made two times at three months intervals. Also clinical evaluation was made with questionnaire forms. The study was approved by the ethical committee and each subject gave informed consent.
Detailed description
It was demonstrated that occlusal splints are effectual on improving clinical symptoms and reducing patient complaints in patients with bruxism. However the effects of occlusal splints on joint vibrations are not fully elucidated. The aim of this study is to evaluate the effects of three different occlusal splints (soft, hard and semi-soft) on joint vibrations in patients with bruxism and to compare with asymptomatic individuals. And also clinical symptoms and patient complaints were evaluated with questionnaire forms.
This study was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. 16 patients were treated with soft splint (group 2), 17 patients were treated with hard splint (group 3) and left 16 patients were treated with semi-soft splint (group 4). Joint vibration records were made with JVA (Biopak system BioResearch , Inc., Milwaukee, WI) device during the opening and closing movements. The recordings were made before and after occlusal splint treatment for three months in patients with bruxism. The recordings of individuals in control group was made two times at three months intervals. Also clinical evaluation was made with questionnaire forms. The study was approved by the ethical committee and each subject gave informed consent.
There was no significant difference in joint vibration parameters between patients with bruxism and asymptomatic individuals before treatment (p>0.0063). Between the increase in soft group and reduction respectively in hard group and semi-soft group for total integral values variations, after treatment at the opening movement for left joint were statistically significant (p=0.005 and p<0.001). Total integral, i>300 Hz, i<300 Hz, Peak amplitude, Peak frequency values of patients with bruxism were observed to be higher than the value of asymptomatic individuals, allthough there was no statistical difference. After three different occlusal splint treatment, it was observed that there was clinically improvement in patient complaints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soft Splint | Experimental | Device: occlusal splintIt is a type of occlusal splint using soft material. It was applied to bruxist patients in accordance with the study design (Group 2). |
| Hard Splint | Experimental | Device: occlusal splintIt is a type of occlusal splint using hard material. It was applied to bruxist patients in accordance with the study design (Group 3). |
| Semi-soft Splint | Experimental | Device: occlusal splintIt is a type of occlusal splint using semi-soft material. They cover the advantages of soft and hard occlusal splints. It was applied to bruxist patients in accordance with the study design (Group 4). |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The patient has a complaint of grinding/clenching during sleep
- One or more of the following occurs:
- No other medical or mental disorders that affecting masticatory muscles activity
Key exclusion criteria (11 listed)
- Patients with missing at least 2 posterior teeth, except for the third molars
- Presence of Myofascial Pain Dysfunction (MPD)
- Presence of major neurological, psychiatric or motor disorders
- Patients using medications, influencing sleep or motor functions
- Patients with alcohol or drug addiction
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 splint | Device | Hard Splint, Semi-soft Splint, Soft Splint |
Primary outcome
Vibration analysis resulting from the movement between temporomandibular joint surfaces with JVA (Joint Vibration Analysis) device
Time frame: 3 days
Joint vibration analysis resulting from the movement between temporomandibular joint surfaces was performed by using a Joint Vibration Analysis device (BioPAK (BioResearch, Inc., Milwaukee, WI). Joint vibration analysis parameters were evaluated after occlusal splint treatments in patients with bruxism for each arm.
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 25 Mar 2025.
- Derived from this study: PubMed 40572771Akat B, Akoren AC, Tamam E. Effects of Different Occlusal Splints on Joint Vibrations in Bruxers. Medicina (Kaunas). 2025 Jun 12;61(6):1083. doi: 10.3390/medicina61061083.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing occlusal splint in people with Bruxism and Bruxism, Sleep, run by Ankara University.
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 11 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Vibration analysis resulting from the movement between temporomandibular joint surfaces with JVA (Joint Vibration Analysis) device (time frame: 3 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 NCT06893744, 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 25 Mar 2025.