Back to resultsComparison of Two Exercise Therapy Protocols in Patients With Bruxism
Primary Purpose
Bruxism
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mandibular Exercise
Mandibular Exercise and Postural Exercise Group
Occlusal Splint Group
Sponsored by
About this trial
This is an interventional treatment trial for Bruxism focused on measuring bruxism, physiotherapy, exercise therapy, occlusal splint, pain, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Adnan Menderes University Faculty of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Mandibular Exercise
Mandibular and Postural Exercise
Occlusal Splint
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Mandibular Motion
change in active mouth opening, lateral jaw movements and protrusion of mandible
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).
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.
Secondary Outcome Measures
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
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).
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.
Full Information
NCT ID
NCT05555628
First Posted
August 26, 2022
Last Updated
September 23, 2022
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT05555628
Brief Title
Comparison of Two Exercise Therapy Protocols in Patients With Bruxism
Official Title
Comparison of Two Exercise Therapy Protocols in Patients With Bruxism: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. Jaw area strengthening exercises) and a control group, (occlusal splint therapy) will take place during the study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism
Keywords
bruxism, physiotherapy, exercise therapy, occlusal splint, pain, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Patients eligible to participate in the study will be assessed by a researcher who is blind to group assignment. The assessor will only see the patients during the evaluation. In this way, the masking of group assignment will be ensured.
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mandibular Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Mandibular and Postural Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Occlusal Splint
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mandibular Exercise
Intervention Description
Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes
Intervention Type
Other
Intervention Name(s)
Mandibular Exercise and Postural Exercise Group
Intervention Description
Patients will receive exercise treatment twice weekly for 6 weeks period. Every session will last approximately 40 minutes
Intervention Type
Other
Intervention Name(s)
Occlusal Splint Group
Intervention Description
Patients will use occlusal splints for 6 weeks. The occlusal splints will be used only sleep time.
Primary Outcome Measure Information:
Title
Mandibular Motion
Description
change in active mouth opening, lateral jaw movements and protrusion of mandible
Time Frame
baseline, 6 week, 12 week
Title
Change in Pain level: pain intensity via Visual Analog Scale
Description
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).
Time Frame
baseline, 6 week, 12 week
Title
Change in Pain level: pain threshold.
Description
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.
Time Frame
baseline, 6 week, 12 week
Secondary Outcome Measure Information:
Title
The Pittsburg Sleep Quality Index was used to assess sleep quality.
Description
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
Time Frame
baseline, 6 week, 12 week
Title
Oral Behaviours Checklist questionnaire was used to examine the oral habits of of the participants.
Description
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).
Time Frame
baseline, 6 week, 12 week
Title
Postural alterations of the patients will be assessed by using the photographic method.
Description
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.
Time Frame
baseline, 6 week, 12 week
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gul Karabicak
Phone
+90 2562138755
Ext
3050
Email
guloznur@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gul Karabicak, PhD
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adnan Menderes University Faculty of Dentistry
City
Aydın
ZIP/Postal Code
09010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gokhan Ozkan
Phone
+90 256 2207062
Ext
7062
12. IPD Sharing Statement
Citations:
PubMed Identifier
2748771
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
17190029
Citation
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.
Results Reference
background
PubMed Identifier
26644658
Citation
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.
Results Reference
background
Citation
American Sleep Disorders Association. The International Classification of Sleep Disorders, Revised: Diagnostic and Coding Manual. Westchester, IL: American Academy of Sleep Medicine; 2005.
Results Reference
background
PubMed Identifier
9069087
Citation
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.
Results Reference
background
PubMed Identifier
18467932
Citation
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.
Results Reference
background
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Comparison of Two Exercise Therapy Protocols in Patients With Bruxism
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