Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
Study NCT ID:
NCT04317768
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2020-03-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Oral Health Education on Oral Health Status, Treatment Needs and Barriers to Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The statistician is blinded to groups.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a cross-sectional study on a randomly selected group of children from randomly selected social homes in Jordan. Children and/or the care giver (n=500) will answer a questionnaire in an interview about his/her demographics, oral health related habits, the child general health status, the child oral health related quality of life, barriers to getting dental care, treatment needs for those children.\n\nA thorough clinical examination will be done to these children by a mouth mirror and explorer at a suitable room in the social home. The investigators will record the baseline oral health status parameters (Caries, gingival health and presence of plaque).\n\nFor the interventions; A representative sample (25%) will be divided to two subgroups; group one (Study) and group two (Control) which will be matched for age and gender.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-27', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of dental caries', 'timeFrame': '1 year', 'description': 'Decayed, missing, filled teeth'}, {'measure': 'Gingival health', 'timeFrame': '1 year', 'description': 'Presence or absence of gingival inflammation'}, {'measure': 'Oral hygiene', 'timeFrame': '1 year', 'description': 'Presence or absence of dental plaque'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral health status', 'Dental treatment needs', 'Barriers to dental care', 'Children at social homes'], 'conditions': ['Dental Caries', 'Gingivitis']}, 'descriptionModule': {'briefSummary': 'Jordanian children have very poor oral hygiene parameters, and this is reflected as very high caries prevalence and poor gingival health conditions. This study will focus on children at social homes in the community in order to establish a baseline reference about their oral health status, treatment needs, and barriers to dental care. Also, to report the efficacy of oral health education using audio-visual aids and frequent motivation on oral health status, treatment needs and barriers to care among children at social homes in Jordan.', 'detailedDescription': 'The oral health status (OHS) for children and adults is a reflection of the whole body general health status as well as the overall quality of life. Jordanian children have very poor oral hygiene parameters, and this is reflected as very high caries prevalence and poor gingival health conditions. Orphans and children who come from broken homes are suspected to have poorer oral health conditions from their peers in the public due to the different parameters that can affect their general health in whole and oral health in particular, and this could affect their quality of life. These parameters can be related to socioeconomic status, psychological and behavioral conditions, access to care and other factors. The role of tooth brushing in decreasing dental caries and enhancing the gingival health is well-established in the literature, and oral health education programs have proven to be effective in improving the oral health knowledge, attitude and behavior of children. These programs could be regarded as an effective measure to enhance the oral health status and establish good routines in childhood which is vital for optimum oral health and provision of lifelong protection against caries.\n\nThis study will focus on children at social homes in the community in order to establish a baseline reference about their oral health status, treatment needs, and barriers to dental care. Also, to report the efficacy of oral health education using audio-visual aids and frequent motivation on oral health status, treatment needs and barriers to care among children at social homes in Jordan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children living in social homes among age group specified\n\nExclusion Criteria:\n\n* Children with poor behavior'}, 'identificationModule': {'nctId': 'NCT04317768', 'briefTitle': 'Effect of Oral Health Education on Oral Health Status, Treatment Needs and Barriers to Care', 'organization': {'class': 'OTHER', 'fullName': 'Jordan University of Science and Technology'}, 'officialTitle': 'The Effectiveness of Oral Health Education Using Audio-visual Aids and Frequent Motivation on Oral Health Status, Treatment Needs and Barriers to Care Among Children at Social Homes in Jordan', 'orgStudyIdInfo': {'id': 'JUST 293-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'They will be educated and motivated by an intensive program consisting of verbal instructions, Power Point lectures, posters and live demonstrations about oral hygiene instructions and teaching the proper way to brush the teeth. These will be reinforced by the investigator at intervals of 1 week, 1 month, 3 months, 6 months and 1 year.', 'interventionNames': ['Behavioral: Basic oral health education and motivation', 'Behavioral: Intensive oral health education and motivation']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'They will receive verbal oral hygiene instructions using a model to demonstrate only once at the beginning of the study, no further motivation or educational seminars will be done.', 'interventionNames': ['Behavioral: Basic oral health education and motivation']}], 'interventions': [{'name': 'Basic oral health education and motivation', 'type': 'BEHAVIORAL', 'description': 'Subjects will receive verbal oral hygiene instructions using a model to demonstrate only once at the beginning of the study, no further motivation or educational seminars will be done.', 'armGroupLabels': ['Control group', 'Study group']}, {'name': 'Intensive oral health education and motivation', 'type': 'BEHAVIORAL', 'description': 'Subjects will be educated and motivated by an intensive program consisting of verbal instructions, PowerPoint lectures, posters and live demonstrations about oral hygiene instructions and teaching the proper way to brush the teeth. These will be reinforced by the investigator at intervals of 1 week, 1 month, 3 months, 6 months and 1 year.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22110', 'city': 'Irbid', 'country': 'Jordan', 'facility': 'Jordan University of Science and Technology', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}], 'overallOfficials': [{'name': 'Ola Al-Batayneh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordan University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}