Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-25 @ 4:40 PM
Study NCT ID:
NCT03833505
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2019-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enterobius Vermicularis and Bruxism in Children
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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2019-01-05', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'BiteStrip', 'timeFrame': '24.03.2017-20.05.2018', 'description': 'For diagnosis of sleep bruxism, a single-use BiteStrip® device (Up2dent, Inc.), including an electromyographic electrode, small display screen and lithium cell, was used to record the increased electromyographic activity of the masticatory muscles during sleep.'}], 'primaryOutcomes': [{'measure': 'Survey', 'timeFrame': '24.03.2017-20.05.2018', 'description': 'The parents of the patients were asked to complete a survey that included questions about the demographic data, medical history of the patient, clinical findings of E. vermicularis and bruxism, other harmful oral habits, family life and habits.'}], 'secondaryOutcomes': [{'measure': 'Oral examination', 'timeFrame': '24.03.2017-20.05.2018', 'description': 'The patients who had a teeth-grinding habit were invited to, our clinic for clinical evaluation of bruxism. Patients were examined under a reflector light with inspection, palpation and mirror-sond. The extraoral examination evaluated mandibular asymmetry, joint sounds, deviation/deflection during opening/closing actions, sensitivity to palpation of masticatory muscles and pain/tenderness, sensitivity to palpation of the temporomandibular joint and masseter muscle hypertrophy10. The intraoral examination assessed the presence of wear facets on the teeth, according to a modification of the method by Johansson. The assessed teeth included primary incisors, canines and molars, permanent incisors and lower first molars. Scores were calculated as follows: 0 = no wear (none); 1 = enamel wear only (mild); 2 = enamel and dentin wear (moderate); 3 = significant loss of tooth structure (severe).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bruxism, Sleep']}, 'referencesModule': {'references': [{'pmid': '19040814', 'type': 'BACKGROUND', 'citation': 'Diaz-Serrano KV, da Silva CB, de Albuquerque S, Pereira Saraiva Mda C, Nelson-Filho P. Is there an association between bruxism and intestinal parasitic infestation in children? J Dent Child (Chic). 2008 Sep-Dec;75(3):276-9.'}, {'pmid': '20567031', 'type': 'BACKGROUND', 'citation': "Mistry P, Moles DR, O'Neill J, Noar J. The occlusal effects of digit sucking habits amongst school children in Northamptonshire (UK). J Orthod. 2010 Jun;37(2):87-92. doi: 10.1179/14653121042939."}, {'pmid': '22013457', 'type': 'BACKGROUND', 'citation': 'Tehrani MH, Pestechian N, Yousefi H, Sekhavati H, Attarzadeh H. The Correlation between Intestinal Parasitic Infections and Bruxism among 3-6 Year-Old Children in Isfahan. Dent Res J (Isfahan). 2010 Summer;7(2):51-5.'}, {'pmid': '27134350', 'type': 'BACKGROUND', 'citation': 'Bortoletto CC, Cordeiro da Silva F, Salgueiro Mda C, Motta LJ, Curiki LM, Mesquita-Ferarri RA, Fernandes KP, Bussadori SK. Evaluation of electromyographic signals in children with bruxism before and after therapy with Melissa Officinalis L-a randomized controlled clinical trial. J Phys Ther Sci. 2016 Mar;28(3):738-42. doi: 10.1589/jpts.28.738. Epub 2016 Mar 31.'}, {'pmid': '17618147', 'type': 'BACKGROUND', 'citation': 'Shochat T, Gavish A, Arons E, Hadas N, Molotsky A, Lavie P, Oksenberg A. Validation of the BiteStrip screener for sleep bruxism. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Sep;104(3):e32-9. doi: 10.1016/j.tripleo.2007.03.009. Epub 2007 Jul 6.'}, {'pmid': '21916926', 'type': 'BACKGROUND', 'citation': 'Emodi-Perlman A, Eli I, Friedman-Rubin P, Goldsmith C, Reiter S, Winocur E. Bruxism, oral parafunctions, anamnestic and clinical findings of temporomandibular disorders in children. J Oral Rehabil. 2012 Feb;39(2):126-35. doi: 10.1111/j.1365-2842.2011.02254.x. Epub 2011 Sep 15.'}, {'pmid': '8468624', 'type': 'BACKGROUND', 'citation': 'Johansson A, Haraldson T, Omar R, Kiliaridis S, Carlsson GE. A system for assessing the severity and progression of occlusal tooth wear. J Oral Rehabil. 1993 Mar;20(2):125-31. doi: 10.1111/j.1365-2842.1993.tb01596.x.'}, {'pmid': '25547142', 'type': 'BACKGROUND', 'citation': 'Karakis D, Dogan A. The craniofacial morphology and maximum bite force in sleep bruxism patients with signs and symptoms of temporomandibular disorders. Cranio. 2015 Jan;33(1):32-7. doi: 10.1179/2151090314Y.0000000009. Epub 2014 Jun 3.'}, {'pmid': '9204506', 'type': 'BACKGROUND', 'citation': 'Van Wyk JA, Van Rensburg LJ, Heitmann LP. Schistosoma mattheei infection in cattle: the course of the intestinal syndrome, and an estimate of the lethal dose of cercariae. Onderstepoort J Vet Res. 1997 Mar;64(1):65-75.'}, {'pmid': '24843394', 'type': 'RESULT', 'citation': 'Karakis D, Dogan A, Bek B. Evaluation of the effect of two different occlusal splints on maximum occlusal force in patients with sleep bruxism: a pilot study. J Adv Prosthodont. 2014 Apr;6(2):103-8. doi: 10.4047/jap.2014.6.2.103. Epub 2014 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'Background. Bruxism is an involuntary, non-functional activity of the masticatory system, and is frequently seen in childhood. Bruxism has many aetiologies, like malocclusion, psychological factors, allergies and gastrointestinal disorders.\n\nAim. To investigate the relationship between Enterobius vermicularis infection and bruxism in children.', 'detailedDescription': 'Bruxism has many aetiologies, like occlusal interferences, malocclusion, malnutrition, psychological factors, allergies and gastrointestinal disorders. Among these gastrointestinal disorders, are various intestinal parasitic infections.\n\nGiven the controversy surrounding the potential association between bruxism and intestinal parasitic infestations, both important health issues, this study sought to evaluate the relationship between E. vermicularis infection and bruxism in E. vermicularis-positive and E. vermicularis-negative 3-10-year-olds children with bruxism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study included E. vermicularis-positive (Group 1, n =13) and E. vermicularis-negative (Group 2: n = 13) children aged between 3-10 years, who were admitted to Aydın Adnan Menderes University Faculty of Medicine Paediatric Gastroenterology Clinic.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Teeth-grinding at least once a week in the last 3 months before recruitment according to the criteria established by the American Academy of Sleep Medicine (AASM)\n* Angle class I occlusion\n* Mesial step occlusion according to flush terminal plane.\n\nExclusion Criteria:\n\n* Treated with anti-helminthic drugs in the last 2 months before recruitment\n* Drugs used that could affect the central nervous system and prevent sleep (sedatives, anti-depressants, neuroleptics, anti-muscarinics, selective serotonin re-uptake inhibitors)\n* Sleep disorders (snoring, insomnia, obstructive sleep apnoea, restless leg syndrome, sleep-related epilepsy)\n* Psychiatric or neurological disorders\n* Upper respiratory system obstruction (last 15 days),\n* Any systemic disease;\n* Teeth erosion due to internal (reflux) or external (acidic drinks) factors\n* Dermatological problems, associated with the use of BiteStrip (Up2dent, Inc., Pulheim, Germany);\n* Unsuitable skin structure;\n* Previously diagnosed and treated for bruxism;\n* Angle class II or class III occlusion'}, 'identificationModule': {'nctId': 'NCT03833505', 'briefTitle': 'Enterobius Vermicularis and Bruxism in Children', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Evaluation of Relationship Between Enterobius Vermicularis Infection and Bruxism in Children', 'orgStudyIdInfo': {'id': '2017/003-24.03.2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1,', 'description': 'E. vermicularis-positive', 'interventionNames': ['Other: Bitestrip']}, {'label': 'Group 2', 'description': 'E. vermicularis-negative', 'interventionNames': ['Other: Bitestrip']}], 'interventions': [{'name': 'Bitestrip', 'type': 'OTHER', 'description': 'The parents of the patients were asked to complete a survey that included questions about the demographic data, medical history of the patient, clinical findings of E. For diagnosis of sleep bruxism, a single-use BiteStrip® device (Up2dent, Inc.), including an electromyographic electrode, small display screen and lithium cell, was used to record the increased electromyographic activity of the masticatory muscles during sleep and bruxism, other harmful oral habits, family life and habits.', 'armGroupLabels': ['Group 1,', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Adnan Menderes University, Faculty of Dentistry, Department of Pediatric Dentistry', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'overallOfficials': [{'name': 'K. Görkem Ulu Güzel', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ADU Faculty of Dentistry Paediatric Dentistry Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Prof', 'investigatorFullName': 'Kadriye Görkem Ulu Güzel', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}