Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT05024669
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2021-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-22', 'studyFirstSubmitDate': '2021-08-14', 'studyFirstSubmitQcDate': '2021-08-22', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of application of the desensitisers on post operative sensitivity on the day of composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.', 'timeFrame': 'Within 24 hours', 'description': 'The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth on the day of restoration on taking cold drinks, hot drinks, and sugar.'}, {'measure': 'Effect of application of the desensitisers on post operative sensitivity one week after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.', 'timeFrame': 'After one week', 'description': 'The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one week after the restoration on taking cold drinks, hot drinks, and sugar.'}, {'measure': 'Effect of application of the desensitisers on post operative sensitivity one month after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.', 'timeFrame': 'after one month', 'description': 'The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one month after the restoration on taking cold drinks, hot drinks, and sugar.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gluma', 'Sheildforce Plus', 'Telio CS', 'Desensitisers'], 'conditions': ['Sensitivity']}, 'descriptionModule': {'briefSummary': 'Composite is one of the common aesthetic restorations used in the dentistry. With the advancements in the biomaterials the application of the composites has broadened. However due to various factors the composites are associated with dental sensitivity. Hence in our study we evaluate and compare the effectiveness of three desensitizing agents in reducing the post-treatment sensitivity for class I composite restoration.', 'detailedDescription': 'A double-blind, randomized, controlled clinical trial was conducted in which 80 subjects requiring class I cavity were randomly assigned to 4 groups of 20 patients each: Group C (Control group), Group GL (Gluma group), Group SF (Shield Force Plus group), and Group TC (Telio CS group). The class 1 cavity was prepared and after etching, the desensitizers were applied (except in the control group) and later composite restoration was done. The postoperative pain/sensitivity level was recorded according to the Visual Analogue Scale (VAS) on intake of cold drinks; intake of hot drinks; and intake of sugar for different periods of time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe selection criteria:\n\n* Age was 20-45 years.\n* Vital teeth, (electric pulp test)\n* Apical periodontal ligament space radiographically identified\n* The remaining dentin thickness at least 1mm.\n\nExclusion Criteria:\n\n* Restored, periodontally weak nonvital teeth are excluded.'}, 'identificationModule': {'nctId': 'NCT05024669', 'briefTitle': 'Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University of Jazan'}, 'officialTitle': 'Efficacy of Three Commercially Available Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Harisha'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'where no desensitizer application was done,'}, {'type': 'EXPERIMENTAL', 'label': 'Group GL', 'description': 'applied with Gluma dentin desensitizer', 'interventionNames': ['Combination Product: Gluma desensitiser']}, {'type': 'EXPERIMENTAL', 'label': 'Group SF', 'description': 'applied with Shieldforce desensitizer', 'interventionNames': ['Combination Product: Sheildforce Plus desensitiser']}, {'type': 'EXPERIMENTAL', 'label': 'Group TC', 'description': 'applied with Telio CS desensitizer', 'interventionNames': ['Combination Product: Telio CS desensitiser']}], 'interventions': [{'name': 'Gluma desensitiser', 'type': 'COMBINATION_PRODUCT', 'description': 'Gluma desensitiser was used before restoration.', 'armGroupLabels': ['Group GL']}, {'name': 'Sheildforce Plus desensitiser', 'type': 'COMBINATION_PRODUCT', 'description': 'Sheildforce Plus desensitiser was used before restoration.', 'armGroupLabels': ['Group SF']}, {'name': 'Telio CS desensitiser', 'type': 'COMBINATION_PRODUCT', 'description': 'Telio CS desensitiser was used before restoration.', 'armGroupLabels': ['Group TC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45142', 'city': 'Jizan', 'country': 'Saudi Arabia', 'facility': 'Harisha Dewan', 'geoPoint': {'lat': 16.88917, 'lon': 42.55111}}], 'overallOfficials': [{'name': 'Harisha Dewan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Jazan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jazan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Harisha Dewan', 'investigatorAffiliation': 'University of Jazan'}}}}