Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06259786
Other study ID # Nocturnal Bruxism
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date March 29, 2024

Study information

Verified date March 2024
Source Karabuk University
Contact Feruza JUMAYEVA Physiotherapist
Phone 05530620797
Email firuzejumayeva@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
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,

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Karabuk University Karabuk

Sponsors (1)

Lead Sponsor Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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

Outcome

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
See also
  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