Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-29 @ 9:51 AM
Study NCT ID:
NCT06953557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Salivary-free Amino Acids Levels (Glycine , Proline , Lysine , and Alanine ) With Caries Activity
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-04-23', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary-free amino acid analysis', 'timeFrame': 'Baseline :unstimulated saliva collection for salivary glycine , proline , lysine and alanine measurement', 'description': 'Unstimulated saliva collection for salivary free amino acids analysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Salivary -free amino acid measurment'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'This study will be aimed to investigated the correlation between levels of salivary amino acids (glycine , proline , lysine , alanine ) in the saliva of healthy children with and without active carious lesions and to estimate the predictive capacity of caries susceptibility', 'detailedDescription': '80 healthy children (8-10 years old) will be recruited from primary schools of Baghdad city/ Iraq, will be classified according to their level of caries activity (high caries activity, n = 40; negative caries activity, n = 40). Total stimulated and unstimulated saliva will be collected to estimate the caries activity by using the Snyder test, and Amino acid analysis of the saliva will be performed by reversed phase - high performance liquid chromatography (RP-HPLC), respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children in both genders in 8-10 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged (8,9,10) years with different caries\n* Absence of signs of gingivitis or periodontal disease.\n\nExclusion Criteria:\n\n* Children out the range of age\n* Children with any systemic discases.\n* Children with appliances in the mouth.\n* Children with appliances in the mouth.\n* Children with antibiotic treatment or any other drug over the last two weeks. B'}, 'identificationModule': {'nctId': 'NCT06953557', 'briefTitle': 'Evaluation of the Salivary-free Amino Acids Levels (Glycine , Proline , Lysine , and Alanine ) With Caries Activity', 'organization': {'class': 'OTHER', 'fullName': 'Al-Mustansiriyah University'}, 'officialTitle': 'Evaluation of the Salivary-free Amino Acids Levels With Caries Activity', 'orgStudyIdInfo': {'id': 'Mustansiriyah'}}, 'armsInterventionsModule': {'interventions': [{'name': 'To compare the effect of salivary glycine , proline , lysine and alanine concentration between participants with high caries activity and participants with negative caries activity', 'type': 'DIAGNOSTIC_TEST', 'description': 'The investigators will measure Salivary-free amino acids by using reverse phase high performance liquid chromatography'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abeer Ibrahim Mohammed, B.D.S', 'role': 'CONTACT', 'email': 'abeeribrahim93@uomustansiriyah.edu.iq', 'phone': '+9647709497799'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Mustansiriyah University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Princible investigator', 'investigatorFullName': 'Abeer Ibrahim Mohammed', 'investigatorAffiliation': 'Al-Mustansiriyah University'}}}}