Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-16 @ 1:40 PM
Study NCT ID:
NCT06509451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retention Rate of Giomer Pit and Fissure Sealant Applied With or Without Etching
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010895', 'term': 'Pit and Fissure Sealants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-26', 'studyFirstSubmitDate': '2024-07-14', 'studyFirstSubmitQcDate': '2024-07-14', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retention rate', 'timeFrame': '3 months, 6months , 1 year', 'description': 'To assess the sealant retention rate either total retention, partial loss or total loss'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caries Prevention']}, 'referencesModule': {'references': [{'pmid': '39511504', 'type': 'DERIVED', 'citation': 'Elmokanen MA, Gad HMA. Retention rate of giomer S-PRG filler containing pit and fissure sealant applied with or without etching: a randomized clinical trial. BMC Oral Health. 2024 Nov 7;24(1):1356. doi: 10.1186/s12903-024-05096-7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the retention rate of Giomer S-PRG filler containing pit and fissure sealant applied with or without etching by using split mouth technique.with null hypothesis that Giomer S-PRG filler containing pit and fissure sealant applied either with or without etching will have the same retention rate.', 'detailedDescription': "Study Settings:\n\nThe study will be carried out at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in Egypt. Ethical approval is taken from the Research Ethics Committee of the faculty of Dentistry, Cairo University. Signed informed consent is signed by each participant.\n\nRecruitment:\n\nParticipants are recruited from the patients' flow at the clinics of the Conservative Dentistry Department of Faculty of Dentistry, Cairo university.\n\nEligibility Criteria:\n\nInclusion Criteria:\n\n1. ICDAS score 0 or 1\n2. Satisfactory oral hygiene\n3. Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)\n4. Satisfactory cooperative behavior\n5. Age between 15- 30 years old\n6. Males or females\n7. Subjects who signed informed consent\n\nExclusion Criteria:\n\n1. ICDAS score \\> 1\n2. Poor oral hygiene\n3. Evidence of tempromandibular joint disorders or malocclusion\n\nMaterials used in this trial are the Giomer S-PRG filler containing pit and fissure sealant (Beautisealant) and its self etching primer (Beauisealant primer).\n\nControl group:\n\nIn the control group, an adequate amount of primer will be applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant will be applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions.\n\nIntervention Group:\n\nIn the intervention group, the same steps will be done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application.\n\nOutcome Assessment:\n\nThe results of sealant retention were assessed according to the following criteria (Simonsen):\n\nA complete retention B partial loss (B1, without caries; B2, with caries) C complete loss (C1, without caries; C2, with caries)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ICDAS score 0 or 1\n2. Satisfactory oral hygiene\n3. Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)\n4. Satisfactory cooperative behavior\n5. Age between 15- 30 years old\n6. Males or females\n7. Subjects who signed informed consent\n\nExclusion Criteria:\n\n1. ICDAS score \\> 1\n2. Poor oral hygiene\n3. Evidence of tempromandibular joint disorders or malocclusion'}, 'identificationModule': {'nctId': 'NCT06509451', 'briefTitle': 'Retention Rate of Giomer Pit and Fissure Sealant Applied With or Without Etching', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Retention Rate of Giomer S-PRG Filler Containing Pit and Fissure Sealant Applied With or Without Etching by Using Split Mouth Technique: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Giomer sealant with etching'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Giomer pit and fissure sealant without etching', 'description': "In the control group, an adequate amount of primer is applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant is applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions.", 'interventionNames': ['Drug: Giomer pit and fissure sealant without etching']}, {'type': 'EXPERIMENTAL', 'label': 'Giomer pit and fissure sealant with etching', 'description': 'In the intervention group, the same steps are done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application.', 'interventionNames': ['Drug: Giomer pit and fissure sealant with etching']}], 'interventions': [{'name': 'Giomer pit and fissure sealant without etching', 'type': 'DRUG', 'otherNames': ['Beautisealant without etching'], 'description': 'S-PRG filler containig pit and fissure sealant without etching step', 'armGroupLabels': ['Giomer pit and fissure sealant without etching']}, {'name': 'Giomer pit and fissure sealant with etching', 'type': 'DRUG', 'otherNames': ['Beautisealant with etching'], 'description': 'S-PRG filler containig pit and fissure sealant with etching step', 'armGroupLabels': ['Giomer pit and fissure sealant with etching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11555', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of dentistry, cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Cairo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Manar abd elmageed ahmed', 'investigatorAffiliation': 'Cairo University'}}}}