Nocturnal Bruxism Clinical Trial
Official title:
Investigation of Mandibular Movement Capacity, Cervical Proprioception, Posture and Quality of Life in Adolescents With Nocturnal Bruxism
Verified date | June 2024 |
Source | Karabuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 29, 2024 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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, |
Country | Name | City | State |
---|---|---|---|
Turkey | Karabuk University | Karabuk |
Lead Sponsor | Collaborator |
---|---|
Karabuk University |
Turkey,
Cakin 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. — View Citation
de 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. — View Citation
Fletcher 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. — View Citation
Manfredini D, Lobbezoo F. Role of psychosocial factors in the etiology of bruxism. J Orofac Pain. 2009 Spring;23(2):153-66. — View Citation
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. — View Citation
Sanches 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. — View Citation
Serra-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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
First Day | |
Secondary | 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. | First Day | |
Secondary | 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. | First Day | |
Secondary | 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. | First day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02870543 -
Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism
|
Phase 3 | |
Recruiting |
NCT03827122 -
Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study
|
Phase 2 | |
Completed |
NCT05620316 -
The Use of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle to Treat Sleep Bruxism
|
N/A |