Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-03 @ 8:15 PM
Study NCT ID:
NCT04737057
Status:
UNKNOWN
Last Update Posted:
2021-02-05
First Post:
2021-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024633', 'term': 'silver diamine fluoride'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'not possible, since interventions are different'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2021-01-31', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Child's behavior", 'timeFrame': 'immediately after the procedure', 'description': "evaluate the Child's behavior by Frankl scale (FS) through Scores (1-2-3-4) ,(higher scores mean a better outcome)"}], 'secondaryOutcomes': [{'measure': 'Canine overbite', 'timeFrame': 'one year', 'description': 'measure the canine over bite discrepancy by Boley Gauge by Millimeter'}, {'measure': 'Arresting caries in SDF', 'timeFrame': 'one year', 'description': 'assess caries activity according to International Caries Detection and Assessment System (ICDAS) through Codes 0-1-2-3-4-5-6 ,( higher scores mean a worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hall technique', 'Silver diamide fluoride', 'non invasive technique'], 'conditions': ['Early Childhood Caries']}, 'descriptionModule': {'briefSummary': 'This study will compare two non- invasive treatment options: Hall technique and 38% Silver diamine fluoride. Both are methods used to create a more favorable environment without removal of caries leading to the arrest of the progression of demineralization process and restoring the function of the diseased molars.', 'detailedDescription': 'Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2\n\nPrevious studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: From 4 to 6 years\n2. Caries in primary molars within enamel / dentin without pulp disease\n\nExclusion Criteria:\n\n1. Presence of signs and symptoms of necrosis\n2. Root caries\n3. Spontaneous pain'}, 'identificationModule': {'nctId': 'NCT04737057', 'briefTitle': "Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:", 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': "Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:", 'orgStudyIdInfo': {'id': 'CairoU1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hall Technique', 'description': 'The Hall Technique is a non-invasive treatment for decayed molar teeth. Decay is sealed under preformed (stainless steel) crowns, avoiding injections and drilling. It is one of a number of biologically orientated strategies for managing dental decay', 'interventionNames': ['Procedure: SDF', 'Procedure: Hall technique']}, {'type': 'EXPERIMENTAL', 'label': 'SDF', 'description': 'a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a promising therapeutic agent for managing caries lesions in young children and those with special care needs', 'interventionNames': ['Procedure: SDF', 'Procedure: Hall technique']}], 'interventions': [{'name': 'SDF', 'type': 'PROCEDURE', 'otherNames': ['Silver Diamine Fluoride'], 'description': 'Apply this topical medication through : 1)Dry with a gentle flow of compressed air to decayed tooth surfaces. 2) Bend micro sponge brush to remove excess liquid before application apply SDF directly to only the affected tooth surface. 3) Apply the SDF material 4)Dry with a gentle flow of compressed air for at least one minute. and Remove excess SDF with gauze', 'armGroupLabels': ['Hall Technique', 'SDF']}, {'name': 'Hall technique', 'type': 'PROCEDURE', 'description': "this technique is performed through :1) Orthodontic separator being stretched between two pieces of floss, then placed between the contact points of primary molars (for five days.) 2)The correct size of crown will not impinge on the teeth on either side, and a slight 'spring back' will be felt when the PMC is gently pushed up to (but not through) the contact points and the PMC has been filled with a Riva self-cure capsule cement, extruded cement is quickly wiped away and the child is asked to keep biting on the crown for two minutes, until the cement is set, to prevent 'spring back' of the PMC from the fully seated position", 'armGroupLabels': ['Hall Technique', 'SDF']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'lamia S El-Sheikh, bachelor', 'role': 'CONTACT', 'email': 'lamiaa.alsheikh@dentistry.cu.edu.eg', 'phone': '+2 01004733637'}], 'overallOfficials': [{'name': 'gihan abo el neil, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'ahmed alkhadem, assistant professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo univeristy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '2 years', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Lamiaa Saeed Ahmed Elshiekh', 'investigatorAffiliation': 'Cairo University'}}}}