Nocturnal BruxismNCT06259786
Investigation of Adolescents With Nocturnal Bruxism
An observational study of Nocturnal Bruxism, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of bruxism on mandibular movement capacity, cervical proprioception, posture and quality of life in adolescents diagnosed with nocturnal bruxism (clenching and grinding teeth while sleeping) between the ages of 13-18 and to compare them with healthy adolescents. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Nocturnal Bruxism
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 29 Mar 2024
- Phase
- Observational
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 20 patients with Nocturnal Bruxism and 20 non-Nocturnal Bruxism Adolescence will be included.
Who may be able to join
- Being diagnosed with nocturnal bruxism,
- Having received parental consent to participate in the study,
- Being between the ages of 13 and 18 (including 13,18 years old)
- Being in good mental state,
- Being able to understand and follow the locations in the work,
- Having a Class 1 occlusion.
Who cannot join
- Not consenting to participate in the study and withdrawing from the study,
- Not being able to cooperate well,
- Having a history of surgery,
- Having any physical disability or chronic disease,
- Having received dental treatment in the last six months,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Mandibular Movement Capacity, Cervical Proprioception, Posture and Quality of Life in Adolescents With Nocturnal Bruxism
The aim of this study is to examine the effects of bruxism on mandibular movement capacity, cervical proprioception, posture and quality of life in adolescents diagnosed with nocturnal bruxism (clenching and grinding teeth while sleeping) between the ages of 13-18 and to compare them with healthy adolescents.
Method: A total of 40 adolescents, 20 with nocturnal bruxism and 20 healthy, will be included in the study. Mandibular movement capacity will be evaluated with a caliper and ruler, cervical proprioception with a CROM device, posture with the New York Posture Scale, and quality of life with the PedsQL 13-18 age scale.
Read more
Hypotheses:
H1: Nocturnal bruxism reduces the movement capacity of the mandible in adolescents.
H2: Nocturnal bruxism reduces cervical proprioception in adolescents. H3: Posture disorder increases in adolescents with nocturnal bruxism. H4: Nocturnal bruxism affects the level of daily life quality in adolescents.
Read the detailed description
Bruxism is defined as repetitive jaw muscle activity characterized by clenching and grinding of teeth caused by mandibular movement.
In addition to being considered as a destructive parafunctional activity of the stomatognathic system, bruxism can cause abnormal tooth wear, damage to periodontal tissues, temporomandibular joints and muscles. Although they are often grouped and named together, there are two types of bruxism: during sleep or while awake. It is suggested that the etiology and physiopathology of bruxism seen during sleep and awake bruxism are different. However, it is stated that psychological factors such as depressive mood and stress are involved in the etiology of both types. While bruxism seen during sleep (nocturnal) is characterized by teeth grinding and clenching, the type seen while awake is more seen as teeth clenching. The pathophysiology of bruxism is still not fully known. Diagnosis and clinical evaluation of bruxism is a complex procedure. Bruxism can be diagnosed when family members observe the typical teeth clenching sound or when the dentist notices abnormal clusal wear. It is an important issue that patients with bruxism in childhood continue this habit in adulthood. Therefore, early diagnosis creates a perspective in terms of controlling the disease, as well as preventing damage to the chewing system components and increasing patient comfort. The most common clinical signs and symptoms observed in oral tissues as a result of bruxism are; wear of teeth, irregularities in supporting tissues, pulp hypersensitivity, tooth mobility, fractures in teeth or restorations, pain, temporomandibular irregularities, hypertrophy of the massater muscle, neck and headache. Wear that occurs as a result of bruxism is characterized by a parallel plane passing through the cutting edges of the teeth. Other intraoral-extraoral findings that may be associated with bruxism are facial asymmetry, inadequate lip closure, mouth breathing, and anterior and posterior crossbite. Although the etiology of bruxism is not fully known; It is suggested that various factors such as local (occlusal interferences), systemic (central nervous system disorders, asthma, rhinitis), psychological (stress, anxiety), occupational (competition sports), hereditary factors, sleep disorders and parasomnia are effective. There is a high probability of developing temporomandibular disorder (TMD) as a result of bruxism.
In these cases, during jaw opening and closing; The presence of deviation/deflection, which are sliding movements, the clicking/crepitation sound heard from the joint, and the mouth opening distance are examined. The stomatognathic system is active in chewing, breathing and speaking functions and is directly related to the cervical spine. Therefore, changes in this system may affect the normal position of the mandible, malocclusion, temporomandibular joint, head posture, and quality of life. The function of the stomatognathic system depends on the synergy of numerous muscles that also participate in other voluntary actions and reflexes. As a result, mandibular function affects both occlusal balance and postural balance. The correct position of the head in space depends on three planes; visual plane, transverse occlusal plane and auricular nasal plane. Together, these three planes maintain a parallel, horizontal relationship that provides stability of head posture through the action of mechanoreceptors in the upper 6 cervical spine. Postural changes have been associated with bruxism. This can be explained by the fact that bruxism affects not only the chewing muscles, but all the muscles of the craniofacial complex, neck and shoulders. Studies with children and adolescents have shown the importance of paying attention to the stage of development of the teeth, as head posture will be affected by dental occlusion. When the literature was examined, no study was found that examined the relationship between quality of life, posture, movement capacity of the mandible and cervical proception in adolescents with nocturnal bruxism. The investigators planned this study to aim to fill this gap in the literature.
- Conditions
- Nocturnal Bruxism
- Keywords
- Nocturnal Bruxism, Posture, Life Quality, Cervical Proprioception, Adolescent
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nocturnal Bruxism | The Quality of Life (The Pediatric Quality of Life Inventory - PedsQL), Postural Changes (New York Posture Analysis - NYPA), Cervical Proprioception (CROM Device), Mandibular Movement Capacity (Maximum Mouth Opening - The Caliper and Excursions- The Linear Rule) will be evaluated. | |
| Healthy Group | The Quality of Life (The Pediatric Quality of Life Inventory - PedsQL), Postural Changes (New York Posture Analysis - NYPA), Cervical Proprioception (CROM Device), Mandibular Movement Capacity (Maximum Mouth Opening - The Caliper and Excursions- The Linear Ruler) will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular movement capacity
For the movement capacity of the mandible, maximum mouth opening is measured using a caliper device, and right/left lateral movement (laterotrusion) and forward movement (protrusion) are measured using a linear ruler.
During the evaluation, the incisal distance is determined as the reference point between the maxillary and mandibular central incisors and is recorded in millimeters (mm). These measurements provide detailed information about the movement capacity of the mandible.
Measured: First Day
Secondary outcomes (3)
Cervical proprioception
CROM device is used to measure the neck joint position sense, which we call cervical proprioception. This device works with an inclinometer system that uses gravity and magnetic effects. With eyes closed, the deviation angles of the head from the neutral position (0 position of the dials) in all 3 planes are recorded. During the evaluation process, the participant is seated in an upright position and the CROM device is placed on his/her head so that it does not slip. Measurements are repeated 3 times and the average of the difference with the target position is taken. Measurements are made separately for flexion, extension, right-left rotation and lateral flexion, and the results are recorded in the data form.
Measured: First Day
New York Posture Scale
Posture changes that may occur in 13 different parts of the body, including head, neck, shoulder, back, waist, hip and ankle, are observed. According to the observation results, five points are given if the person has a correct posture, three points are given if the posture is moderately impaired, and one point is given if there is a serious impairment. The total score obtained as a result of the test varies between minimum 13 and maximum 65.
Measured: First Day
Pediatric quality of life questionnaire
It is a quality of life scale developed by Varni et al. in 1999, as a result of approximately 15 years of study, to measure the health-related quality of life of children and adolescents between the ages of 2 and 18. PedsQL, one of the general quality of life scales, is a 23-item quality of life scale that is suitable for use in large populations such as schools and hospitals, and in both healthy and diseased children and adolescents. Items are scored between 0 and 100. The higher the PedsQL total score, the better the health-related quality of life is perceived. The most important features of the PedsQL are that it is short, can be completed in approximately 5-10 minutes, and is easy to administer and score by the researcher.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Feb 2024
- Primary completion29 Feb 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nocturnal 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, METEHAN YANA, Karabuk University
- Investigators
- Feruza JUMAYEVA Physiotherapist, Study chair, Karabuk UniversityMusa GÜNEŞ MsC, Study director, Karabuk UniversityMetehan YANA PhD, Principal investigator, Karabuk UniversityKader AZLAĞ PEKİNCE PhD, Study director, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259786
- Sponsor's protocol ID
- Nocturnal Bruxism
- Status last verified
- Jun 2024
- First submitted
- 6 Feb 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manfredini D, Restrepo C, Diaz-Serrano K, Winocur E, Lobbezoo F. Prevalence of sleep bruxism in children: a systematic review of the literature. J Oral Rehabil. 2013 Aug;40(8):631-42. doi: 10.1111/joor.12069. Epub 2013 May 24.
PubMed 23700983Manfredini D, Lobbezoo F. Role of psychosocial factors in the etiology of bruxism. J Orofac Pain. 2009 Spring;23(2):153-66.
PubMed 19492540Serra-Negra JM, Paiva SM, Auad SM, Ramos-Jorge ML, Pordeus IA. Signs, symptoms, parafunctions and associated factors of parent-reported sleep bruxism in children: a case-control study. Braz Dent J. 2012;23(6):746-52. doi: 10.1590/s0103-64402012000600020.
PubMed 23338271de Oliveira Reis L, Ribeiro RA, Martins CC, Devito KL. Association between bruxism and temporomandibular disorders in children: A systematic review and meta-analysis. Int J Paediatr Dent. 2019 Sep;29(5):585-595. doi: 10.1111/ipd.12496. Epub 2019 Apr 15.
PubMed 30888712Cakin Memik N, Agaoglu B, Coskun A, Uneri OS, Karakaya I. [The validity and reliability of the Turkish Pediatric Quality of Life Inventory for children 13-18 years old]. Turk Psikiyatri Derg. 2007 Winter;18(4):353-63. Turkish.
PubMed 18066726Fletcher JP, Bandy WD. Intrarater reliability of CROM measurement of cervical spine active range of motion in persons with and without neck pain. J Orthop Sports Phys Ther. 2008 Oct;38(10):640-5. doi: 10.2519/jospt.2008.2680.
PubMed 18827326Sanches ML, Juliano Y, Novo NF, Guimaraes AS, Rodrigues Conti PC, Alonso LG. Correlation between pressure pain threshold and pain intensity in patients with temporomandibular disorders who are compliant or non-compliant with conservative treatment. Oral Surg Oral Med Oral Pathol Oral Radiol. 2015 Oct;120(4):459-68. doi: 10.1016/j.oooo.2015.05.017. Epub 2015 May 29.
PubMed 26188733
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Mandibular Movement Capacity, Cervical Proprioception, Posture and Quality of Life in Adolescents With Nocturnal Bruxism
- ClinicalTrials.gov ID
- NCT06259786
- Acronym / sponsor ID
- Nocturnal Bruxism
- Conditions
- Nocturnal Bruxism
- Keywords
- Nocturnal Bruxism, Posture, Life Quality, Cervical Proprioception, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 14 Feb 2024 (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.
The aim of this study is to examine the effects of bruxism on mandibular movement capacity, cervical proprioception, posture and quality of life in adolescents diagnosed with nocturnal bruxism (clenching and grinding teeth while sleeping) between the ages of 13-18 and to compare them with healthy adolescents.
Method: A total of 40 adolescents, 20 with nocturnal bruxism and 20 healthy, will be included in the study. Mandibular movement capacity will be evaluated with a caliper and ruler, cervical proprioception with a CROM device, posture with the New York Posture Scale, and quality of life with the PedsQL 13-18 age scale.
Hypotheses:
H1: Nocturnal bruxism reduces the movement capacity of the mandible in adolescents.
H2: Nocturnal bruxism reduces cervical proprioception in adolescents. H3: Posture disorder increases in adolescents with nocturnal bruxism. H4: Nocturnal bruxism affects the level of daily life quality in adolescents.
Detailed description
Bruxism is defined as repetitive jaw muscle activity characterized by clenching and grinding of teeth caused by mandibular movement.
In addition to being considered as a destructive parafunctional activity of the stomatognathic system, bruxism can cause abnormal tooth wear, damage to periodontal tissues, temporomandibular joints and muscles. Although they are often grouped and named together, there are two types of bruxism: during sleep or while awake. It is suggested that the etiology and physiopathology of bruxism seen during sleep and awake bruxism are different. However, it is stated that psychological factors such as depressive mood and stress are involved in the etiology of both types. While bruxism seen during sleep (nocturnal) is characterized by teeth grinding and clenching, the type seen while awake is more seen as teeth clenching. The pathophysiology of bruxism is still not fully known. Diagnosis and clinical evaluation of bruxism is a complex procedure. Bruxism can be diagnosed when family members observe the typical teeth clenching sound or when the dentist notices abnormal clusal wear. It is an important issue that patients with bruxism in childhood continue this habit in adulthood. Therefore, early diagnosis creates a perspective in terms of controlling the disease, as well as preventing damage to the chewing system components and increasing patient comfort. The most common clinical signs and symptoms observed in oral tissues as a result of bruxism are; wear of teeth, irregularities in supporting tissues, pulp hypersensitivity, tooth mobility, fractures in teeth or restorations, pain, temporomandibular irregularities, hypertrophy of the massater muscle, neck and headache. Wear that occurs as a result of bruxism is characterized by a parallel plane passing through the cutting edges of the teeth. Other intraoral-extraoral findings that may be associated with bruxism are facial asymmetry, inadequate lip closure, mouth breathing, and anterior and posterior crossbite. Although the etiology of bruxism is not fully known; It is suggested that various factors such as local (occlusal interferences), systemic (central nervous system disorders, asthma, rhinitis), psychological (stress, anxiety), occupational (competition sports), hereditary factors, sleep disorders and parasomnia are effective. There is a high probability of developing temporomandibular disorder (TMD) as a result of bruxism.
In these cases, during jaw opening and closing; The presence of deviation/deflection, which are sliding movements, the clicking/crepitation sound heard from the joint, and the mouth opening distance are examined. The stomatognathic system is active in chewing, breathing and speaking functions and is directly related to the cervical spine. Therefore, changes in this system may affect the normal position of the mandible, malocclusion, temporomandibular joint, head posture, and quality of life. The function of the stomatognathic system depends on the synergy of numerous muscles that also participate in other voluntary actions and reflexes. As a result, mandibular function affects both occlusal balance and postural balance. The correct position of the head in space depends on three planes; visual plane, transverse occlusal plane and auricular nasal plane. Together, these three planes maintain a parallel, horizontal relationship that provides stability of head posture through the action of mechanoreceptors in the upper 6 cervical spine. Postural changes have been associated with bruxism. This can be explained by the fact that bruxism affects not only the chewing muscles, but all the muscles of the craniofacial complex, neck and shoulders. Studies with children and adolescents have shown the importance of paying attention to the stage of development of the teeth, as head posture will be affected by dental occlusion. When the literature was examined, no study was found that examined the relationship between quality of life, posture, movement capacity of the mandible and cervical proception in adolescents with nocturnal bruxism. The investigators planned this study to aim to fill this gap in the literature.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nocturnal Bruxism | – | –The Quality of Life (The Pediatric Quality of Life Inventory - PedsQL), Postural Changes (New York Posture Analysis - NYPA), Cervical Proprioception (CROM Device), Mandibular Movement Capacity (Maximum Mouth Opening - The Caliper and Excursions- The Linear Rule) will be evaluated. |
| Healthy Group | – | –The Quality of Life (The Pediatric Quality of Life Inventory - PedsQL), Postural Changes (New York Posture Analysis - NYPA), Cervical Proprioception (CROM Device), Mandibular Movement Capacity (Maximum Mouth Opening - The Caliper and Excursions- The Linear Ruler) will be evaluated. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 20 patients with Nocturnal Bruxism and 20 non-Nocturnal Bruxism Adolescence will be included.
Key inclusion criteria (6 listed)
- Being diagnosed with nocturnal bruxism,
- Having received parental consent to participate in the study,
- Being between the ages of 13 and 18 (including 13,18 years old)
- Being in good mental state,
- Being able to understand and follow the locations in the work,
Key exclusion criteria (5 listed)
- Not consenting to participate in the study and withdrawing from the study,
- Not being able to cooperate well,
- Having a history of surgery,
- Having any physical disability or chronic disease,
- Having received dental treatment in the last six months,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mandibular movement capacity
Time frame: First Day
For the movement capacity of the mandible, maximum mouth opening is measured using a caliper device, and right/left lateral movement (laterotrusion) and forward movement (protrusion) are measured using a linear ruler. During the evaluation, the incisal distance is determined as the reference point between the maxillary and mandibular central incisors and is recorded in millimeters (mm). These measurements provide detailed information about the movement capacity of the mandible.
3 secondary outcomes
Cervical proprioception
Time frame: First Day
New York Posture Scale
Time frame: First Day
Pediatric quality of life questionnaire
Time frame: First day
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 18 Jun 2024.
- Background: PubMed 23700983Manfredini D, Restrepo C, Diaz-Serrano K, Winocur E, Lobbezoo F. Prevalence of sleep bruxism in children: a systematic review of the literature. J Oral Rehabil. 2013 Aug;40(8):631-42. doi: 10.1111/joor.12069. Epub 2013 May 24.
- Background: PubMed 19492540Manfredini D, Lobbezoo F. Role of psychosocial factors in the etiology of bruxism. J Orofac Pain. 2009 Spring;23(2):153-66.
- Background: PubMed 23338271Serra-Negra JM, Paiva SM, Auad SM, Ramos-Jorge ML, Pordeus IA. Signs, symptoms, parafunctions and associated factors of parent-reported sleep bruxism in children: a case-control study. Braz Dent J. 2012;23(6):746-52. doi: 10.1590/s0103-64402012000600020.
- Background: PubMed 30888712de Oliveira Reis L, Ribeiro RA, Martins CC, Devito KL. Association between bruxism and temporomandibular disorders in children: A systematic review and meta-analysis. Int J Paediatr Dent. 2019 Sep;29(5):585-595. doi: 10.1111/ipd.12496. Epub 2019 Apr 15.
- Background: PubMed 18066726Cakin Memik N, Agaoglu B, Coskun A, Uneri OS, Karakaya I. [The validity and reliability of the Turkish Pediatric Quality of Life Inventory for children 13-18 years old]. Turk Psikiyatri Derg. 2007 Winter;18(4):353-63. Turkish.
- Background: PubMed 18827326Fletcher JP, Bandy WD. Intrarater reliability of CROM measurement of cervical spine active range of motion in persons with and without neck pain. J Orthop Sports Phys Ther. 2008 Oct;38(10):640-5. doi: 10.2519/jospt.2008.2680.
- Background: PubMed 26188733Sanches ML, Juliano Y, Novo NF, Guimaraes AS, Rodrigues Conti PC, Alonso LG. Correlation between pressure pain threshold and pain intensity in patients with temporomandibular disorders who are compliant or non-compliant with conservative treatment. Oral Surg Oral Med Oral Pathol Oral Radiol. 2015 Oct;120(4):459-68. doi: 10.1016/j.oooo.2015.05.017. Epub 2015 May 29.
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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.
Feruza JUMAYEVA Physiotherapist study chair
Karabuk University
Musa GÜNEŞ MsC study director
Karabuk University
Metehan YANA PhD principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturnal Bruxism, run by Karabuk 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 6 inclusion and 5 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 18 Jun 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 movement capacity (time frame: First Day). 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 NCT06259786, which also lists 7 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 18 Jun 2024.