Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04930458
Status:
UNKNOWN
Last Update Posted:
2022-05-17
First Post:
2021-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012969', 'term': 'Sodium Fluoride'}, {'id': 'C094502', 'term': 'Bifluorid 12'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of patient with arrested dental caries using international caries detection and assessment system II(ICDAS II)', 'timeFrame': 'Change in the state of dental caries after one and 3 months after topical application of nanosilver fluoride and sodium fluoride with casein phosphopeptides amorphous calcium phosphate', 'description': 'The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by blunt probe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental caries remineralization', 'Nanosilver fluoride'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between nanosilver fluoride and sodium fluoride with Casein phosphopeptides\\_amorphous calcium phosphate in the remineralization of dental caries.', 'detailedDescription': 'the patients will be randomly assigned to one of three study groups the first group is nanosilver fluoride,the second is casein phosphopeptides\\_amorphous calcium phosphate and the third is sodium fluoride as positive control..the three material will be applied in single application with no repetition ..follow up after one and three month ..the patient should have at least one carious lesion(ICDASII code 5)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Clinical diagnosis of carious lesion\n* participants should be free of any systemic diseases.\n\nExclusion Criteria:\n\n* sensitivity to Silver or other heavy-metal ions or any milk-related allergies and medical conditions involving the kidneys.\n* The tooth was excluded if it had pulp exposure, abscess/fistula, sensitivity to percussion'}, 'identificationModule': {'nctId': 'NCT04930458', 'briefTitle': 'Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Remineralization of Dentine Caries Using Nanosilver Fluoride and Casein Phosphopeptides-amorphous Calcium Phosphate (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'Dentine caries remineralizatio'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nanosilver fluoride group', 'description': 'Nanosilver fluoride will be applied on carious lesion', 'interventionNames': ['Other: Nanosilver fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group', 'description': 'Sodium fluoride with casein phosphopeptides\\_Amorphous calcium phosphate will be applied on carios lesion', 'interventionNames': ['Other: Sodium fluoride with casein phosphopeptides amorphous calcium phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium fluoride varnish group', 'description': 'Sodium fluoride varnish will be applied on carios lesion', 'interventionNames': ['Other: Sodium fluoride varnish']}], 'interventions': [{'name': 'Nanosilver fluoride', 'type': 'OTHER', 'description': 'Nanosilver fluoride will be applied to the affected tooth in single application and then follow up after one and three months', 'armGroupLabels': ['Nanosilver fluoride group']}, {'name': 'Sodium fluoride with casein phosphopeptides amorphous calcium phosphate', 'type': 'OTHER', 'description': 'Sodium fluoride with casein phosphopeptides amorphous calcium phosphatewill be applied to the affected tooth in single application and then follow up after one and three months', 'armGroupLabels': ['Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group']}, {'name': 'Sodium fluoride varnish', 'type': 'OTHER', 'description': 'Sodium fluoride varnish will be applied to the affected tooth in single application and then follow up after one and three months', 'armGroupLabels': ['Sodium fluoride varnish group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karbala', 'status': 'RECRUITING', 'country': 'Iraq', 'contacts': [{'name': 'Duaa Jawad', 'role': 'CONTACT', 'email': 'Duaajawad1@gmail.com', 'phone': '07707535959'}, {'name': 'Aseel Haider', 'role': 'CONTACT', 'email': 'dr.aseelhaider@codental.uobaghdad.edu.iq', 'phone': '07901810659'}], 'facility': 'Alhur alriyahi specialized dental center', 'geoPoint': {'lat': 32.61603, 'lon': 44.02488}}], 'centralContacts': [{'name': 'Duaa Jawad', 'role': 'CONTACT', 'email': 'duaajawad1@gmail.com', 'phone': '07707535959'}, {'name': 'Aseel Haider', 'role': 'CONTACT', 'email': 'dr.aseelhaider@codental.uobaghdad.edu.iq', 'phone': '07901810659'}], 'overallOfficials': [{'name': 'Duaa Jawad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Baghdad'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dentist.. master student', 'investigatorFullName': 'duaa jawad', 'investigatorAffiliation': 'University of Baghdad'}}}}