Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-31 @ 9:29 PM
Study NCT ID:
NCT06937333
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain and Mobility in Children With Sleep Bruxism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020186', 'term': 'Sleep Bruxism'}], 'ancestors': [{'id': 'D002012', 'term': 'Bruxism'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain pressure threshold', 'timeFrame': 'Baseline', 'description': 'Pain pressure threshold was evaluated the algometer.'}, {'measure': 'Range of motion', 'timeFrame': 'Baseline', 'description': 'Cervical range of motion was evaluated with the cervical range of motion device (CROM) developed by the University of Minnesota, USA,'}, {'measure': 'Functional Independence', 'timeFrame': 'Baseline', 'description': 'Functional Independence was evaluated the with the Pediatric Functional Independence Measure. The total score varies between 18-126 and as the score increases, the dependency increases.'}, {'measure': 'Sleep quality', 'timeFrame': 'Baseline', 'description': 'Sleep quality was evaluated the Pitsburg Sleep Quality Index. The total score ranges from 0 to 21, and as the score increases, sleep quality decreases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bruxism, Sleep']}, 'referencesModule': {'references': [{'pmid': '32223910', 'type': 'RESULT', 'citation': 'Brancher LC, Cademartori MG, Jansen K, da Silva RA, Bach S, Reyes A, Boscato N, Goettems ML. Social, emotional, and behavioral problems and parent-reported sleep bruxism in schoolchildren. J Am Dent Assoc. 2020 May;151(5):327-333. doi: 10.1016/j.adaj.2020.01.025. Epub 2020 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'Bruxism is defined as a repetitive jaw muscle activity characterized by clenching and grinding teeth caused by mandibular movement. Sleep bruxism is frequently seen and can affect the quality of life of individuals. Since bruxism is characterized by clenching teeth, it can cause pain. However, the relationship between bruxism and pain has not been sufficiently studied in the literature. The relationship between the temporamandibular joint and the cervical region is known. However, the relationship between bruxism and cervical mobility is not clear. Since there may be temporamandibular joint problems in bruxism, it can affect joint movement. The sleep quality of individuals may decrease and this may lead to problems in functionality. However, when the literature is examined, the relationship between bruxism and functional independence in children has not been explained. Therefore, the aim of the study was to compare the pain, range of motion, sleep quality and functional independence of children with bruxism and healthy controls.', 'detailedDescription': 'Bruxism is defined as repetitive jaw muscle activity characterized by clenching and grinding teeth caused by mandibular movement. Sleep bruxism is frequently seen and can affect the quality of life of individuals. Since bruxism is characterized by clenching teeth, it can cause pain. However, the relationship between bruxism and pain has not been sufficiently studied in the literature. In addition, bruxism can cause problems in joint mobility of the cervical region by affecting the activation of muscles. Although the relationship between the temporomandibular joint and the cervical region is clearly known, the relationship between bruxism and cervical mobility is not clear. For this reason, sleep problems are frequently seen in individuals. The sleep quality of individuals decreases and can cause problems in functionality. However, when the literature is examined, the relationship between bruxism and functional independence in children has not been explained. Since bruxism can reduce the quality of life of individuals due to the indirect effects it causes, it should be seen and evaluated not only as a disorder involving the jaw joint, but as a problem affecting the entire body. Therefore, the aim of the study was to compare pain, range of motion, sleep quality and functional independence in children with bruxism and healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with bruxism and healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having been diagnosed with Nocturnal Bruxism\n* Having received parental consent to participate in the study\n* Being between the ages of 13-18\n* Being in good mental condition\n* Being able to understand and follow the instructions in the study\n* Having Class 1 occlusion\n\nExclusion Criteria:\n\n* Not consenting to participate in the study or withdrawing from the study\n* Not being able to cooperate well\n* Having a history of surgery\n* Having any physical disability or chronic disease\n* Having received dental treatment in the last 6 months'}, 'identificationModule': {'nctId': 'NCT06937333', 'briefTitle': 'Pain and Mobility in Children With Sleep Bruxism', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Investigation of Pain, Cervical Joint Range of Motion, and Sleep Quality in Children With Bruxism', 'orgStudyIdInfo': {'id': 'Karabuk-007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sleep bruxism', 'description': 'Children diagnosed with sleep bruxism were included in this study.'}, {'label': 'Control Group', 'description': 'Age- and sex-matched healthy children were included.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000', 'city': 'Karabük', 'country': 'Turkey (Türkiye)', 'facility': 'Karabük University', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}], 'overallOfficials': [{'name': 'Metehan Yana, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karabuk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, PT, PhD', 'investigatorFullName': 'METEHAN YANA', 'investigatorAffiliation': 'Karabuk University'}}}}