Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-02-09 @ 5:35 AM
Study NCT ID:
NCT06449950
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Different Oral Hygiene Instructions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor -performing the final examination- carried out the final OHI-S index scoring blindly without knowing which Oral Hygiene Instruction group (verbal and video-based) the participants were in.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'For each age group (6-9 and 10-12) participants were randomly assigned to verbal and video-based oral hygiene instruction groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simplified Oral Hygiene Index (OHI-S) Scoring', 'timeFrame': '30 days', 'description': 'In the present study, 30 days after verbal and video-based oral hygiene instructions were given to patients, oral hygiene status was similarly determined and recorded using OHI-S index method (OHI-S final scores).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral health education', 'Oral hygiene', 'Pediatric dental patients', 'Toothbrushing'], 'conditions': ['Oral Hygiene Education', 'Oral Hygiene Education Methods']}, 'referencesModule': {'references': [{'pmid': '39887898', 'type': 'DERIVED', 'citation': 'Demirel A, Guclu HS, Guclu M, Bagis N. Evaluation of Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):575-583. doi: 10.1111/idh.12898. Epub 2025 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S). Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages). Patients were re-called for after 30 days and final OHI-S scores were recorded.', 'detailedDescription': 'In pediatric dentistry, preventive dental approaches are essential in providing sustainable oral health of children. Despite all the preventive applications, dental caries is still an important public health problem affecting preschool and school children. Oral hygiene education has an important role on the dental health services. This aims to increase awareness of oral health, provide information about it and encourage individuals to maintain oral health. Based on, the current study aims to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S). Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages). Patients were re-called for after 30 days and final OHI-S scores were recorded. Data were analysed with Shapiro-Wilk, Mann-Whitney U and Wilcoxon Signed Rank tests. Statistical significance level was considered as 5%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-9 years or 10-12 years\n* Children who were medically free of chronic/systemic conditions\n* Patients without physical or mental disabilities or syndromes\n* Patients without motor dysfunction diseases\n* Patients whose permanent central incisor and permanent first molar teeth had erupted and had not been extracted for any reason\n\nExclusion Criteria:\n\n* Children aged \\<6 or \\>12 years\n* Children with chronic/systemic conditions\n* Patients with physical or mental disabilities or syndromes\n* Patients with motor dysfunction diseases\n* Patients whose permanent central incisor and permanent first molar teeth had not erupted'}, 'identificationModule': {'nctId': 'NCT06449950', 'briefTitle': 'The Effects of Different Oral Hygiene Instructions', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'The Evaluation of the Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '11/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verbal Oral Hygiene Instruction Group', 'description': 'Verbal oral hygiene instructions were given to the pediatric patients by the instructor using the Bass brushing technique without any training model or visual aids, only with the verbal instructions.', 'interventionNames': ['Behavioral: Behavioral: Verbal Oral Hygiene Instructions']}, {'type': 'EXPERIMENTAL', 'label': 'Video-Based Oral Hygiene Instruction Group', 'description': 'The video-based oral hygiene instructions to be delivered to the paediatric dental participants were given by watching a pre-prepared video tape on a tooth and jaw model, using the instructions specified in the verbal education.', 'interventionNames': ['Behavioral: Behavioral: Video-Based Oral Hygiene Instructions']}], 'interventions': [{'name': 'Behavioral: Verbal Oral Hygiene Instructions', 'type': 'BEHAVIORAL', 'description': 'OHI-S index scores of patients who received verbal oral hygiene education were measured at baseline and final (in post-education).', 'armGroupLabels': ['Verbal Oral Hygiene Instruction Group']}, {'name': 'Behavioral: Video-Based Oral Hygiene Instructions', 'type': 'BEHAVIORAL', 'description': 'OHI-S index scores of patients who received video-based oral hygiene education were measured at baseline and final (in post-education).', 'armGroupLabels': ['Video-Based Oral Hygiene Instruction Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Akif Demirel', 'investigatorAffiliation': 'Ankara University'}}}}