Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT04967794
Status:
UNKNOWN
Last Update Posted:
2021-07-20
First Post:
2021-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Teleorientation in Oral Hygiene During the COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The clinical trial is a simple blind study in which the sample will be randomized into three groups, whose participants will be "blinded" to the types of intervention'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study population will be divided into three groups that will receive the intervention by communication platform, teleconsultation platform in health and in person.all individuals participating in the group will receive toothbrushing guidelines as a preventive measure for the development of dental caries'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-16', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual assessment of groups', 'timeFrame': '1 month', 'description': "Assess the children's visible plaque index individually by photo"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eHealth, mobile health'], 'conditions': ['Dental Caries in Children']}, 'referencesModule': {'availIpds': [{'id': 'CAAE 39685920.7.0000.5419', 'url': 'https://plataformabrasil.saude.gov.br/', 'type': 'Informed Consent Form', 'comment': 'Through this address it is possible to identify the information about acceptance by the ethics committee of Univerdade São Paulo and also the consent form'}], 'references': [{'pmid': '32827598', 'type': 'BACKGROUND', 'citation': 'Lotto M, Strieder AP, Ayala Aguirre PE, Oliveira TM, Andrade Moreira Machado MA, Rios D, Cruvinel T. Parental-oriented educational mobile messages to aid in the control of early childhood caries in low socioeconomic children: A randomized controlled trial. J Dent. 2020 Oct;101:103456. doi: 10.1016/j.jdent.2020.103456. Epub 2020 Aug 20.'}]}, 'descriptionModule': {'briefSummary': "The present study aims to evaluate the effectiveness of Teleorientation in oral hygiene during Pandemic by COVID-19 in children aged 6 to 10 years, attended at the Pediatric Clinic of Forp. For this, a randomized clinical study will be carried out with the factor to be analyzed the comparison between synchronous and asynchronous teleorientation, the effectiveness of the transfer of knowledge in oral hygiene through video modeling and remote guidance. The response variables will be the assimilation of oral hygiene guidance through video modeling and synchronous guidance, the hypothesis is that educational content will have beneficial effects on children's oral health.", 'detailedDescription': 'This is a randomized clinical trial, whose sample is composed of thirty children aged 6 to 10 years, attended between the year 2019 and the beginning of 2020. The sample will be randomly randomized into 3 groups who received guidance on toothbrushing. group 1 will be done Teleorientation of tooth brushing through video call by the Whatsapp application, in group 2 will be done Teleorientation of toothbrushing through a platform designed exclusively for teleconsultations and group 3 will receive the same in-person brushing orientation.\n\nThe main purpose of the clinical trial is to develop and analyze a program of Teleorientation of Toothbrushing in children of the Pediatric Dentistry clinic of FORP.\n\nThe Specific Objectives are assess whether oral hygiene is taking place properly during the COVID-19 Pandemic, assess, through a questionnaire, the level of understanding of parents and caregivers regarding the information received. This project will be designed as a randomized study with a two-month follow-up. The study factor will be to compare synchronous with asynchronous teleorientation, the effectiveness of knowledge transfer in oral hygiene through video modeling and remote orientation. The response variables will be the assimilation of guidance in oral hygiene by video modeling and by synchronous guidance, the hypothesis is that educational content will have beneficial effects on the oral health of children. The procedures will be performed at the Pediatric Dentistry Clinic of the Faculty of Dentistry of Ribeirão Preto - University of São Paulo - FORP/USP. The CONSORT guide (Schulz et al., 2010) for randomized controlled trials will be followed for the design of the present study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children aged 6 to 8 years old,\n* attended at Forp's Pediatric Dentistry Clinic,\n* with complete record in the medical record,\n* parents or caregivers who have Smartphone and Internet access\n* and who are willing to download the V4H and\n* WhatsApp application and\n* accept to participate in all stages of the research upon acceptance of the consent form.\n\nExclusion Criteria\n\n* :Children who present pain and/or spontaneous sensitivity,\n* motor difficulties and\n* health disorders ."}, 'identificationModule': {'nctId': 'NCT04967794', 'briefTitle': 'Effectiveness of Teleorientation in Oral Hygiene During the COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effectiveness of Teleorientation in Oral Hygiene During the COVID-19 Pandemic, a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CAAE 39685920.7.0000.5419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Whatsapp', 'description': 'Will receive standardized brushing Teleorientation consultation through the Whatsapp communication platform', 'interventionNames': ['Other: Teleorientation and Tooth Brushing Orientation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Vídeo for Health', 'description': 'You will receive a standardized brushing Teleorientation consultation through the V4H Platform, created specifically for Teleconsultations', 'interventionNames': ['Other: Teleorientation and Tooth Brushing Orientation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group de Orientação presencial', 'description': 'You will receive a standardized face-to-face brushing orientation consultation.', 'interventionNames': ['Other: Teleorientation and Tooth Brushing Orientation']}], 'interventions': [{'name': 'Teleorientation and Tooth Brushing Orientation', 'type': 'OTHER', 'description': 'Guide children in toothbrushing with a preventive purpose during the COVID-19 pandemic', 'armGroupLabels': ['Group Vídeo for Health', 'Group Whatsapp', 'Group de Orientação presencial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14021-370', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marília Gr Gomes, Master', 'role': 'CONTACT', 'email': 'm_goulardins@usp.br', 'phone': '11993155133'}, {'name': 'Marília Goulardins', 'role': 'CONTACT', 'email': 'm_goulardins@usp.br', 'phone': '55 11993155133'}, {'name': 'Andiara De Rossi, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fernanda S Liévana, Master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana Paula D Moreno, Master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fernanda A Carrer, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mary Caroline S Macedo, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Marilia G Gomes', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'centralContacts': [{'name': 'Marília Goulardins', 'role': 'CONTACT', 'email': 'm_goulardins@usp.br', 'phone': '11993155133'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Make the study visible to other researchers through the sharing link'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's student in Pediatric Dentistry", 'investigatorFullName': 'Marília Goulardins', 'investigatorAffiliation': 'University of Sao Paulo'}}}}