Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-01-26 @ 10:55 AM
Study NCT ID:
NCT06714695
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Crossover Clinical Study to Evaluate the Effect of Chitosan Mouthwash on Recurrence of Black Stains in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D048271', 'term': 'Chitosan'}], 'ancestors': [{'id': 'D002686', 'term': 'Chitin'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-28', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2024-11-28', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of Black stains', 'timeFrame': '36 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Black stains', 'chromogenic', 'Children', 'Pediatric', 'Recurrence'], 'conditions': ['Black Stains']}, 'referencesModule': {'references': [{'pmid': '29411532', 'type': 'BACKGROUND', 'citation': 'Milleman KR, Creeth JE, Burnett GR, Milleman JL. A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation. J Esthet Restor Dent. 2018 Mar;30(2):E45-E51. doi: 10.1111/jerd.12355. Epub 2018 Feb 7.'}, {'type': 'BACKGROUND', 'citation': 'Qin C, Li H., Xiao Q, Liu Y, Zhu J, Du Y. Water-solubility of chitosan and its antimicrobial activity, Carbohydr Polyr 2006; 63:367-74.'}, {'pmid': '11985199', 'type': 'BACKGROUND', 'citation': 'Koch MJ, Bove M, Schroff J, Perlea P, Garcia-Godoy F, Staehle HJ. Black stain and dental caries in schoolchildren in Potenza, Italy. ASDC J Dent Child. 2001 Sep-Dec;68(5-6):353-5, 302.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Chitosan mouthwash works to affect the recurrence of black stains in pediatric patients. The main questions it aims to answer are:\n\nDoes Chitosan mouthwash lower the number of times participants need to do a scaling and polishing cleaning sessions more than normal? Does Chitosan mouthwash will decrease the recurrence of black stains in children and improve esthetics ?\n\nParticipants will:\n\nTake chitosan every day for 4 months Visit the clinic once every 6 weeks for checkups and data collection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Cooperative child to be able to perform and tolerate different oral hygiene procedures 2. Parents providing informed consent 3. Accept 18 weeks follow up period 4. Teeth showing black stains without calculus.\n\nExclusion Criteria:\n\n* 1\\. Patients with Allergic reactions to food \\& drugs containing derivatives from crustacean organisms. 2. Taking any antibiotic drugs within 2- week period before sample collection. 3. Taking any dietary supplements containing iron. 4. Teeth selected should be free of caries 5. Free of any developmental defects'}, 'identificationModule': {'nctId': 'NCT06714695', 'briefTitle': 'A Crossover Clinical Study to Evaluate the Effect of Chitosan Mouthwash on Recurrence of Black Stains in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of the Effective Concentration of Chitosan Mouthwash on the Recurrence of Black Stains in Pediatric Patients. a Crossover Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '(P-PE-22-03)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pediatric patients before and after using chitosan mouthwash', 'description': 'pediatric patients with black stains will be recruited in the study. Scaling and polishing will be done then followed up for 3 months, then scaling and polishing will be repeated after follow up period and the patient will be given chitosan mouthwash to be used for additional 3 months.', 'interventionNames': ['Drug: Chitosan']}], 'interventions': [{'name': 'Chitosan', 'type': 'DRUG', 'description': 'chitosan mouthwash', 'armGroupLabels': ['Pediatric patients before and after using chitosan mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Inas M Talaat', 'role': 'CONTACT', 'email': 'dent.g@azhar.edu.eg', 'phone': '+202-24053623'}, {'name': 'Mohamed H Mostafa', 'role': 'CONTACT'}], 'facility': 'Faculty of dental medicine Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Rawda W Hassan', 'role': 'CONTACT', 'email': 'rawda.el.hariry@gmail.com', 'phone': '+201005703873'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Misr International University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctorate candidate in faculty of dental medicine Azhar university girls', 'investigatorFullName': 'Rawda wagih Mostafa Hassan', 'investigatorAffiliation': 'Al-Azhar University'}}}}