BruxismNCT05555628

Comparison of Two Exercise Therapy Protocols in Patients With Bruxism

A study testing Mandibular Exercise, Mandibular Exercise and Postural Exercise Group and Occlusal Splint Group in people with Bruxism, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main purpose of this planned research is to investigate the effectiveness of three different methods used for the treatment of bruxism. Two of these are physiotherapy-specific exercise treatment protocols (1.posture and proprioception exercises 2. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Bruxism
What is being tested?: Mandibular Exercise, Mandibular Exercise and Postural Exercise Group and Occlusal Splint Group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Jul 2022to 15 Mar 2024
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Diagnosis of sleep Bruxism according to the criteria of the International Classification of Sleep Disorders (ICSD) of the American Academy of Sleep Medicine (AASM) (5);
18-50 age range
The diagnosis of awake bruxism, which was determined by a positive answer to the questions of the questionnaire developed according to Pintado's recommendations (6);
Pain around the jaw is 3 or more on the visual analog scale (7)
Patients who volunteered to participate in the study

Who cannot join

Systemic and/or degenerative disorders
Neurological or psychiatric diseases (excluding anxiety and depression)
Use of drugs that affect sleep or motor behavior
Arthrogenic or mixed temporomandibular disorder
Axis I myogenic TMD according to investigational diagnostic criteria for temporomandibular disorders (RDC/TMD)
Patients using total prosthesis

Show all 11Show fewer

Direct trauma or previous surgical intervention in the orofacial region
Patients using muscle relaxants and non-steroidal anti-inflammatory drugs.
Patients using removable prostheses
Patients who have received any treatment for bruxism
Patients who did not want to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Adnan Menderes University Faculty of Dentistry
Aydin, 09010

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Two Exercise Therapy Protocols in Patients With Bruxism: A Randomized Controlled Trial

Read the detailed description

The current study is planned as a parallel group, randomized controlled trial. Patients who apply to Adnan Menderes University Faculty of Dentistry between June 2022 and January 2023 and diagnosed with bruxism after the examination will be screened for the study. Aydın Adnan Menderes University Faculty of Dentistry is a hospital that serves an average of 400 patients per day.

Conditions: Bruxism
Being tested: Mandibular Exercise, Mandibular Exercise and Postural Exercise Group, Occlusal Splint Group
Keywords: bruxism, physiotherapy, exercise therapy, occlusal splint, pain, rehabilitation
Medical subject headings: Bruxism, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mandibular ExerciseOther
Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes
Mandibular Exercise and Postural Exercise GroupOther
Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes
Occlusal Splint GroupOther
Patients will use occlusal splints for 6 weeks. The occlusal splints will be used only sleep time.

Study groups in NCT05555628
Study group	Role	What they receive
Mandibular Exercise	Experimental	At the beginning of the treatment, the therapist will perform a soft tissue massage to the patient's muscles. Then, an exercise protocol for specific muscles (masseter, temporal muscles, mandibular region muscles) will be administered. This group, the exercise will focus only on the chin area, not general like posture. Receives: Other: Mandibular Exercise
Mandibular and Postural Exercise	Experimental	The patients will perform posture exercises, including stabilization of the upper body and cervical region, accompanied by a physiotherapist. A theraband suitable for the patient's muscular strength will be used for posture exercises,. The appropriate therabant selection will be decided by a maximum repetition method. Receives: Other: Mandibular Exercise; Other: Mandibular Exercise and Postural Exercise Group
Occlusal Splint	Active comparator	The patients assigned to this group will be treated by the occlusal splint administered by the dentist and the recommendations that they should pay attention to in daily life. Occlusal splints will be prepared according to previously published criteria by Okeson and other researchers. Occlusal splint measurement and production will be done by technicians with 5 years of experience. Using the models obtained from the maxillary measurements of the patients, 0.5 mm thick thermoplastic rigid splints will be prepared and adjusted according to the patient's occlusion. Occlusal splints will be prepared for night use only. Patients will use splints every night for 6 weeks. Splint use of the patients and possible side effects or plaque-related disorders will be followed up with phone calls to be made every 2 weeks. Receives: Other: Occlusal Splint Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Mandibular Motion
change in active mouth opening, lateral jaw movements and protrusion of mandible
Measured: baseline, 6 week, 12 week
Change in Pain level: pain intensity via Visual Analog Scale
Visual analog scale will be used for the change in pain severity. In a straight line adjusted to 10 cm, the patient is asked to mark the intensity of pain felt at the moment on jaw area. A value of 0 is used to describe the absence of pain, and a value of 10 to describe an unbearable pain. Patients will be asked to rate their pain at the time of assessment (not in the past week or month).
Measured: baseline, 6 week, 12 week
Change in Pain level: pain threshold.
Pressure algometry will be used to assess the pain threshold. This device, which has a pressure area of 1 cm in diameter, shows the applied pressure objectively. The pressure algometer, will be applied by pressing the patient's trigger points (masseter, temporal, trapezius muscles) at an angle of 90 degrees, is calculated by recording the pressure that occurs when the person expresses that he/she feels the pain for the first time. The patient will be positioned seated. The average of the three measurement results to be made is recorded as an evaluation.
Measured: baseline, 6 week, 12 week

Secondary outcomes (3)

The Pittsburg Sleep Quality Index was used to assess sleep quality.
The Pittsburg Sleep Quality Index was developed by Buysse et al. (1989) to evaluate sleep quality in psychiatry practices and clinical studies (1). The items in the PUKI were arranged using clinical observations of patients with sleep disorders, other scales related to sleep quality mentioned in the literature, and an 18-month clinical observation period related to The Pittsburg Sleep Quality Index. The Turkish validity and reliability study of this scale was carried out by Ağargün (1996) (2). The total score of the questionnaire ranges between 0 to 21. 5 points and more refers to bad sleep quality
Measured: baseline, 6 week, 12 week
Oral Behaviours Checklist questionnaire was used to examine the oral habits of of the participants.
The questionnaire, which questions how often parafunctional habits such as clenching, grinding, nail, lip, cheek, pencil biting, gum chewing have been done in the last month, is answered with a 4-point Likert scale. The total score of the the Oral Behaviours Checklist will be used for the analyses. A person's overall score can range from 0 to 84. The validity and reliability of the questionnaire has been demonstrated within the scope of the RDC/TMD Validation project (3).
Measured: baseline, 6 week, 12 week
Postural alterations of the patients will be assessed by using the photographic method.
Within the scope of the evaluation, craniovertebral and craniocervical angles will be evaluated. For this purpose, an silence environment where the patients are comfortable will be provided, and photographs will be taken from the same lateral direction with the help of a camera located on a triple stand 1.5m away, fixed at a height of 115cm. All necessary procedure explanations are available in the relevant resource (4). With this method, an objective numerical data is obtained for the evaluation of cervical posture.
Measured: baseline, 6 week, 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202215 Mar 2024

First posted27 Sep 2022
Study start15 Jul 2022
Primary completion15 Feb 2024
Study completion15 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for BruxismStudies of the same condition, open and under way.
More trials run by Aydin Adnan Menderes 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: Patients in Groups I and II will be included in an exercise program that will last for 45 minutes, two days a week, for 6 weeks. All treatments will be carried out by a physiotherapist with more than 10 years of experience in the field. The patients will be treated independently from each other. The treatment protocols of the patients in exercise therapy group will be revised with 2-week controls, and their progress will be followed up with new exercises. Patients who do not come to two consequtive treatments to the treatment protocol will be excluded from the study. Occlusal Splint Group; It will consist of two separate sessions, one week apart. It is aimed to eliminate possible incompatibilities by calling the patients for the control one week after the splints are delivered. Assessments will be performed three times: prior to group assignment (baseline), immediately after the end of the treatment (week 6), and at the control of the 12th week.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05555628
Sponsor's protocol ID: 92340882-050.04.04
Status last verified: Nov 2024
First submitted: 26 Aug 2022
Last updated: 21 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Ağargün, M.Y., Kara, H., Anlar, Ö. (1996). The validity and reliability of the Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi, 7 (2), 107-115.
Markiewicz MR, Ohrbach R, McCall WD Jr. Oral behaviors checklist: reliability of performance in targeted waking-state behaviors. J Orofac Pain. 2006 Fall;20(4):306-16.
PubMed 17190029
Hazar Z, Karabicak GO, Tiftikci U. Reliability of photographic posture analysis of adolescents. J Phys Ther Sci. 2015 Oct;27(10):3123-6. doi: 10.1589/jpts.27.3123. Epub 2015 Oct 30.
PubMed 26644658
American Sleep Disorders Association. The International Classification of Sleep Disorders, Revised: Diagnostic and Coding Manual. Westchester, IL: American Academy of Sleep Medicine; 2005.
Pintado MR, Anderson GC, DeLong R, Douglas WH. Variation in tooth wear in young adults over a two-year period. J Prosthet Dent. 1997 Mar;77(3):313-20. doi: 10.1016/s0022-3913(97)70189-6.
PubMed 9069087
Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
PubMed 18467932
Karabicak GO, Alkan Demetoglu G, Ozkan G, Gunaydin G, Onal Aykar S, Gunaydin OE. Jaw Exercise Versus Jaw & Posture Exercise Therapies in Comparison to Occlusal Splint Effectiveness in Probable Sleep Bruxism: A Randomised Controlled Study. J Oral Rehabil. 2025 Oct;52(10):1629-1640. doi: 10.1111/joor.14027. Epub 2025 May 14.
PubMed 40369740

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Bruxism trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Exercise Therapy Protocols in Patients With Bruxism: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05555628
Acronym / sponsor ID: 92340882-050.04.04
Conditions: Bruxism
Keywords: bruxism, physiotherapy, exercise therapy, occlusal splint, pain, rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Aydin Adnan Menderes UniversityUniversity, hospital or other
Study start: 15 Jul 2022 (actual)
Primary completion: 15 Feb 2024 (actual)
Study completion: 15 Mar 2024 (actual)
First posted: 27 Sep 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Patients in Groups I and II will be included in an exercise program that will last for 45 minutes, two days a week, for 6 weeks. All treatments will be carried out by a physiotherapist with more than 10 years of experience in the field. The patients will be treated independently from each other. The treatment protocols of the patients in exercise therapy group will be revised with 2-week controls, and their progress will be followed up with new exercises. Patients who do not come to two consequtive treatments to the treatment protocol will be excluded from the study. Occlusal Splint Group; It will consist of two separate sessions, one week apart. It is aimed to eliminate possible incompatibilities by calling the patients for the control one week after the splints are delivered. Assessments will be performed three times: prior to group assignment (baseline), immediately after the end of the treatment (week 6), and at the control of the 12th week.

Arm	Type	Receives
Mandibular Exercise	Experimental	Other: Mandibular ExerciseAt the beginning of the treatment, the therapist will perform a soft tissue massage to the patient's muscles. Then, an exercise protocol for specific muscles (masseter, temporal muscles, mandibular region muscles) will be administered. This group, the exercise will focus only on the chin area, not general like posture.
Mandibular and Postural Exercise	Experimental	Other: Mandibular Exercise, Other: Mandibular Exercise and Postural Exercise GroupThe patients will perform posture exercises, including stabilization of the upper body and cervical region, accompanied by a physiotherapist. A theraband suitable for the patient's muscular strength will be used for posture exercises,. The appropriate therabant selection will be decided by a maximum repetition method.
Occlusal Splint	Active comparator	Other: Occlusal Splint GroupThe patients assigned to this group will be treated by the occlusal splint administered by the dentist and the recommendations that they should pay attention to in daily life. Occlusal splints will be prepared according to previously published criteria by Okeson and other researchers. Occlusal splint measurement and production will be done by technicians with 5 years of experience. Using the models obtained from the maxillary measurements of the patients, 0.5 mm thick thermoplastic rigid splints will be prepared and adjusted according to the patient's occlusion. Occlusal splints will be prepared for night use only. Patients will use splints every night for 6 weeks. Splint use of the patients and possible side effects or plaque-related disorders will be followed up with phone calls to be made every 2 weeks.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Diagnosis of sleep Bruxism according to the criteria of the International Classification of Sleep Disorders (ICSD) of the American Academy of Sleep Medicine (AASM) (5);
18-50 age range
The diagnosis of awake bruxism, which was determined by a positive answer to the questions of the questionnaire developed according to Pintado's recommendations (6);
Pain around the jaw is 3 or more on the visual analog scale (7)
Patients who volunteered to participate in the study

Key exclusion criteria (11 listed)

Systemic and/or degenerative disorders
Neurological or psychiatric diseases (excluding anxiety and depression)
Use of drugs that affect sleep or motor behavior
Arthrogenic or mixed temporomandibular disorder
Axis I myogenic TMD according to investigational diagnostic criteria for temporomandibular disorders (RDC/TMD)

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
Mandibular ExercisePatients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes	Other	Mandibular Exercise, Mandibular and Postural Exercise
Mandibular Exercise and Postural Exercise GroupPatients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes	Other	Mandibular and Postural Exercise
Occlusal Splint GroupPatients will use occlusal splints for 6 weeks. The occlusal splints will be used only sleep time.	Other	Occlusal Splint

Primary outcome

Mandibular Motion
Time frame: baseline, 6 week, 12 week
change in active mouth opening, lateral jaw movements and protrusion of mandible
Change in Pain level: pain intensity via Visual Analog Scale
Time frame: baseline, 6 week, 12 week
Visual analog scale will be used for the change in pain severity. In a straight line adjusted to 10 cm, the patient is asked to mark the intensity of pain felt at the moment on jaw area. A value of 0 is used to describe the absence of pain, and a value of 10 to describe an unbearable pain. Patients will be asked to rate their pain at the time of assessment (not in the past week or month).
Change in Pain level: pain threshold.
Time frame: baseline, 6 week, 12 week
Pressure algometry will be used to assess the pain threshold. This device, which has a pressure area of 1 cm in diameter, shows the applied pressure objectively. The pressure algometer, will be applied by pressing the patient's trigger points (masseter, temporal, trapezius muscles) at an angle of 90 degrees, is calculated by recording the pressure that occurs when the person expresses that he/she feels the pain for the first time. The patient will be positioned seated. The average of the three measurement results to be made is recorded as an evaluation.

3 secondary outcomes

The Pittsburg Sleep Quality Index was used to assess sleep quality.
Time frame: baseline, 6 week, 12 week
Oral Behaviours Checklist questionnaire was used to examine the oral habits of of the participants.
Time frame: baseline, 6 week, 12 week
Postural alterations of the patients will be assessed by using the photographic method.
Time frame: baseline, 6 week, 12 week

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 21 Nov 2024.
Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
BackgroundAğargün, M.Y., Kara, H., Anlar, Ö. (1996). The validity and reliability of the Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi, 7 (2), 107-115.
Background: PubMed 17190029Markiewicz MR, Ohrbach R, McCall WD Jr. Oral behaviors checklist: reliability of performance in targeted waking-state behaviors. J Orofac Pain. 2006 Fall;20(4):306-16.
Background: PubMed 26644658Hazar Z, Karabicak GO, Tiftikci U. Reliability of photographic posture analysis of adolescents. J Phys Ther Sci. 2015 Oct;27(10):3123-6. doi: 10.1589/jpts.27.3123. Epub 2015 Oct 30.
BackgroundAmerican Sleep Disorders Association. The International Classification of Sleep Disorders, Revised: Diagnostic and Coding Manual. Westchester, IL: American Academy of Sleep Medicine; 2005.
Background: PubMed 9069087Pintado MR, Anderson GC, DeLong R, Douglas WH. Variation in tooth wear in young adults over a two-year period. J Prosthet Dent. 1997 Mar;77(3):313-20. doi: 10.1016/s0022-3913(97)70189-6.
Background: PubMed 18467932Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
Derived from this study: PubMed 40369740Karabicak GO, Alkan Demetoglu G, Ozkan G, Gunaydin G, Onal Aykar S, Gunaydin OE. Jaw Exercise Versus Jaw & Posture Exercise Therapies in Comparison to Occlusal Splint Effectiveness in Probable Sleep Bruxism: A Randomised Controlled Study. J Oral Rehabil. 2025 Oct;52(10):1629-1640. doi: 10.1111/joor.14027. Epub 2025 May 14.

Related trials for Bruxism

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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.

Gul Karabicak, PhD principal investigator

Aydin Adnan Menderes University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 21 Nov 2024. 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?

Mandibular Motion (time frame: baseline, 6 week, 12 week). The study lists 3 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 NCT05555628, which also lists 8 linked publications.

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 21 Nov 2024.