Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-06 @ 2:56 PM
Study NCT ID:
NCT02989233
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2016-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Three Different Education Methods on Oral Hygiene
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-12', 'studyFirstSubmitDate': '2016-12-08', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Theoretical Test Application', 'timeFrame': 'Baseline and 6 months after treatment', 'description': 'The changes in theoretical test scores after education'}], 'secondaryOutcomes': [{'measure': 'Gingival index', 'timeFrame': 'Baseline and 6 months after treatment', 'description': 'The changes in gingival index after education'}, {'measure': 'Plaque index', 'timeFrame': 'Baseline and 6 months after treatment', 'description': 'The changes in plaque index after education'}, {'measure': 'Bleeding on probing', 'timeFrame': 'Baseline and 6 months after treatment', 'description': 'The changes in bleeding on probing after education'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oral Hygiene']}, 'descriptionModule': {'briefSummary': 'In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated.', 'detailedDescription': 'Aim: The aim the present study was to evaluate the impact of three different education methods on the oral hygiene levels of school children using clinical and theoretical findings.\n\nMethods: In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated. The data was statistically analysed by using Kolmogorov-Smirnov and One-way ANOVA tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* According to the Simplified Oral Hygiene Index, the patients having the score of 2 and over were accepted.\n\nExclusion Criteria:\n\n* According to the Simplified Oral Hygiene Index, the patients having the score under 2 were not included in the study'}, 'identificationModule': {'nctId': 'NCT02989233', 'briefTitle': 'Impact of Three Different Education Methods on Oral Hygiene', 'organization': {'class': 'OTHER', 'fullName': 'Bulent Ecevit University'}, 'officialTitle': 'Impact of Three Different Education Methods on Oral Hygiene and Theoretical Knowledge of Schoolchildren', 'orgStudyIdInfo': {'id': '36290600/93'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Brochure-Female-8/10', 'description': 'Female 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brochure-Male-8/10', 'description': 'Male 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model-Female-8/10', 'description': 'Female 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model-Male-8/10', 'description': 'Male 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Video-Female-8/10', 'description': 'Female 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Video-Male-8/10', 'description': 'Male 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brochure-Female-11/13', 'description': 'Female 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brochure-Male-11/13', 'description': 'Male 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model-Female-11/13', 'description': 'Female 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model-Male-11/13', 'description': 'Male 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Video-Female-11/13', 'description': 'Female 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Video-Male-11/13', 'description': 'Male 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment', 'interventionNames': ['Other: Non-surgical periodontal treatment']}], 'interventions': [{'name': 'Non-surgical periodontal treatment', 'type': 'OTHER', 'description': 'Scaling and oral hygiene instructions with brochure, model or video', 'armGroupLabels': ['Brochure-Female-11/13', 'Brochure-Female-8/10', 'Brochure-Male-11/13', 'Brochure-Male-8/10', 'Model-Female-11/13', 'Model-Female-8/10', 'Model-Male-11/13', 'Model-Male-8/10', 'Video-Female-11/13', 'Video-Female-8/10', 'Video-Male-11/13', 'Video-Male-8/10']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umut BALLI', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Faculty of Dentistry', 'investigatorFullName': 'Umut BALLI', 'investigatorAffiliation': 'Bulent Ecevit University'}}}}