Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-11 @ 4:23 AM
Study NCT ID:
NCT07003958
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-18', 'size': 922856, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-26T10:55', 'hasProtocol': True}, {'date': '2023-12-18', 'size': 758910, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-26T10:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-08-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Marginal Coloration Evaluation Criteria', 'timeFrame': 'Following the sealant application, checks will be made at3, 6, 12 and 24 months', 'description': 'Marginal Coloration Evaluation Criteria 0 No color change between fissure sealant and tooth. 1 Color change in only one area. 2 Color change in many areas. 3 Severe color change indicating leakage.'}, {'measure': 'Anatomical Form Evaluation Criteria', 'timeFrame': 'Following the sealant application, checks will be made at 3,6, 12 and 24 months', 'description': 'Anatomical Form Evaluation Criteria 0 Consistent with and continuous with occlusal form and structure. 1 Change in anatomical form but all pits and fissures covered. 2a Partial loss of one or two pits or fissures but no need to repair or replace fissure sealant. 2b Partial loss of pits and fissures, fissure sealant needs to be replaced or repaired. 3 Loss of all pits and fissures. 7 Partial loss due to occlusion 9 Bleb not connected to margins'}], 'primaryOutcomes': [{'measure': 'Modified Simonsen Criteria', 'timeFrame': 'Following the sealant application, controls will be made at 3,6, 12 and 24 months', 'description': 'Modified Simonsen Criteria Score 0 Fissure sealant is completely in the mouth and there is no new caries. Score 1 Partial loss of fissure sealant, no new caries. Score 2 Partial loss of fissure sealant and new caries. Score 3 Complete loss of fissure sealant, no new caries. Score 4 Complete loss of fissure sealant and new caries.'}], 'secondaryOutcomes': [{'measure': 'Edge Integrity Evaluation Criteria', 'timeFrame': 'Following the sealant application, controls will be made at 3,6, 12 and 24 months.', 'description': 'Edge Integrity Evaluation Criteria 0 The fissure sealant and tooth surface are intact and cannot be distinguished with a probe. 1 The edges of the fissure sealants can be distinguished with a probe. 2 There is a gap along the edge of the fissure sealant and deep cracks reaching the central fossa.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deproteinization agents', 'sodium hypochlorite', 'hypochlorous acid', 'fissure sealent', 'Primary Teeth'], 'conditions': ['Fissure Sealant']}, 'referencesModule': {'references': [{'pmid': '11145354', 'type': 'RESULT', 'citation': 'Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. doi: 10.1177/00220345000790110601.'}, {'pmid': '1835987', 'type': 'RESULT', 'citation': 'Simonsen RJ. Retention and effectiveness of dental sealant after 15 years. J Am Dent Assoc. 1991 Oct;122(10):34-42. doi: 10.14219/jada.archive.1991.0289.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of the effect of deproteinization agents on the clinical success of non-invasive fissure sealant application, which is a non-invasive method used to prevent caries formation or to stop the progression of initial caries lesions limited to enamel on tooth surfaces thought to be at high risk of caries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 4-6 who do not have any systemic problems\n* Have a score of 3 and 4 on the Frankl Behavior Scale\n* Do not have a habit of clenching and/or grinding their teeth\n* Have lower second primary molars without caries\n* Have an indication for fissure sealant application\n\nExclusion Criteria:\n\n* Teeth with fissure sealants\n* Teeth with developmental defects such as hypoplasia\n* Teeth with approximal or incipient caries lesions on one or both mandibular second primary molars'}, 'identificationModule': {'nctId': 'NCT07003958', 'briefTitle': 'The Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth: Splint Mouth Clinical Study', 'orgStudyIdInfo': {'id': '23-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium Hypochlorite, Wizard', 'description': 'There are many studies in the literature showing that the use of 5.25% NaOCl as an enamel deproteinization agent is successful in positively affecting adhesion by removing organic elements from both the enamel structure and the pellicle on the enamel surface before acid application. However, sodium hypochlorite is a strong oxidizing agent and has disadvantages such as the risk of reaction in the soft tissues of the mouth, bad odor and bad taste, especially if not used carefully in pediatric dentistry, which has led to the search for an alternative material.', 'interventionNames': ['Other: application of deproteinization agents']}, {'type': 'EXPERIMENTAL', 'label': 'Hypochlorous Acid, Superox', 'description': "Hypochlorous acid is produced by the body's immune system cells, neutrophilic polymorphonuclear leukocytes, as a result of oxidative reactions to overcome pathogenic microorganisms and fight infection. Recently, slightly acidic HOCl solutions, developed by electrolysis of NaOCl, have been widely used as disinfectants. Hypochlorous acid has been shown to significantly reduce the lipopolysaccharide concentration of Porphyromonas gingivalis compared to NaOCl and chlorhexidine and to be an agent tolerated by oral tissues. It has also been reported that HOCl used as a mouthwash does not produce any systemic side effects. In clinical dentistry, HOCl has been shown to be highly effective as a result of its antimicrobial and deproteinizing properties. HOCl, with its low acidity, is an antiseptic irrigant with extraordinary properties, not only exhibiting biocompatibility and low cytotoxicity, but also having rapid and highly effective antimicrobial activity in physiological concentration ran", 'interventionNames': ['Other: application of deproteinization agents']}], 'interventions': [{'name': 'application of deproteinization agents', 'type': 'OTHER', 'description': 'Since there is no in vivo study in the literature evaluating the clinical success of the use of hypochlorous acid for deproteinization in fissure sealants, our planned study is the first in this regard.', 'armGroupLabels': ['Hypochlorous Acid, Superox', 'Sodium Hypochlorite, Wizard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60100', 'city': 'Tokat Province', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'alem coşgun', 'role': 'CONTACT', 'email': 'alemcosgun@hotmail.com', 'phone': '05524133222'}], 'facility': 'Tokat Gaziosmanpaşa University, Tokat, 60030', 'geoPoint': {'lat': 40.31389, 'lon': 36.55444}}], 'centralContacts': [{'name': 'alem coşgun', 'role': 'CONTACT', 'email': 'alemcosgun@hotmail.com', 'phone': '+905524133222'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant proffessor', 'investigatorFullName': 'Alem Coşgun', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}