Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
Study NCT ID:
NCT02939092
Status:
UNKNOWN
Last Update Posted:
2018-01-24
First Post:
2016-10-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005884', 'term': 'Gingival Hemorrhage'}], 'ancestors': [{'id': 'D006472', 'term': 'Oral Hemorrhage'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding on brushing, Measurement: asking patient , Unit: Binary', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival Bleeding on probing'], 'conditions': ['Gingival Bleeding']}, 'referencesModule': {'references': [{'pmid': '23762148', 'type': 'BACKGROUND', 'citation': "Howell AB, D'Souza DH. The pomegranate: effects on bacteria and viruses that influence human health. Evid Based Complement Alternat Med. 2013;2013:606212. doi: 10.1155/2013/606212. Epub 2013 May 20."}, {'pmid': '26955605', 'type': 'BACKGROUND', 'citation': 'Umar D, Dilshad B, Farhan M, Ali A, Baroudi K. The effect of pomegranate mouthrinse on Streptococcus mutans count and salivary pH: An in vivo study. J Adv Pharm Technol Res. 2016 Jan-Mar;7(1):13-6. doi: 10.4103/2231-4040.173266.'}, {'pmid': '25728105', 'type': 'BACKGROUND', 'citation': 'Tulsani SG, Chikkanarasaiah N, Siddaiah SB, Krishnamurthy NH. The effect of Propolis and Xylitol chewing gums on salivary Streptococcus mutans count: a clinical trial. Indian J Dent Res. 2014 Nov-Dec;25(6):737-41. doi: 10.4103/0970-9290.152182.'}, {'pmid': '12397186', 'type': 'BACKGROUND', 'citation': 'Ajdic D, McShan WM, McLaughlin RE, Savic G, Chang J, Carson MB, Primeaux C, Tian R, Kenton S, Jia H, Lin S, Qian Y, Li S, Zhu H, Najar F, Lai H, White J, Roe BA, Ferretti JJ. Genome sequence of Streptococcus mutans UA159, a cariogenic dental pathogen. Proc Natl Acad Sci U S A. 2002 Oct 29;99(22):14434-9. doi: 10.1073/pnas.172501299. Epub 2002 Oct 23.'}, {'pmid': '15943766', 'type': 'BACKGROUND', 'citation': 'Filoche SK, Soma K, Sissons CH. Antimicrobial effects of essential oils in combination with chlorhexidine digluconate. Oral Microbiol Immunol. 2005 Aug;20(4):221-5. doi: 10.1111/j.1399-302X.2005.00216.x.'}, {'pmid': '24800189', 'type': 'BACKGROUND', 'citation': 'Zarfeshany A, Asgary S, Javanmard SH. Potent health effects of pomegranate. Adv Biomed Res. 2014 Mar 25;3:100. doi: 10.4103/2277-9175.129371. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://doi.org/10.4103/2231-4040.173266', 'label': 'Related Info'}, {'url': 'http://www.ijdr.in/text.asp?2014/25/6/737/152182', 'label': 'Related Info'}, {'url': 'http://onlinelibrary.wiley.com/doi/10.1111/j.1399-302X.2005.00216.x/abstract', 'label': 'Related Info'}, {'url': 'http://doi.org/10.4103/2277-9175.129371', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.', 'detailedDescription': 'To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.\n\nPICO:\n\nPopulation (P): Children with full permanent dentition. Intervention (I): Pomegranates peel extract. Comparator (C): Chlorhexidine.\n\nOutcome(O):\n\nPrimary outcome: Bleeding on brushing, criteria:Asking patient, unit:Binary. Secondary outcome:Counting streptococcus mutans, criteria: Agar plate, unit: CFUs/mL'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children aged 12-15 years old.\n* Cooperative children.\n* Both genders.\n* Medically free.\n\nExclusion Criteria:\n\n* Children undergoing orthodontic treatment.\n* Children using any other oral hygiene aid other than routine teeth brushing.\n* Children with known history of allergy to any mouth rinse or drug.\n* Parents unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT02939092', 'briefTitle': 'The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing Among a Group of Egyptian Children With Full Permanent Dentition, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CairoE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pomegranate peel extract', 'description': 'Pomegranate is antimicrobial, anti inflammatory and antioxidant', 'interventionNames': ['Drug: Pomegranates peel extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine', 'description': 'Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis', 'interventionNames': ['Drug: Chlorhexidine']}], 'interventions': [{'name': 'Pomegranates peel extract', 'type': 'DRUG', 'description': 'Pomegranate is antimicrobial', 'armGroupLabels': ['Pomegranate peel extract']}, {'name': 'Chlorhexidine', 'type': 'DRUG', 'description': 'Chlorhexidine mouthwash is antiplaque agent', 'armGroupLabels': ['Chlorhexidine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Heba M Fouad, Bachelor', 'role': 'CONTACT', 'email': 'heba.fouad@dentistry.cu.edu.eg', 'phone': '01001798183'}, {'name': 'Manal El shiekh, Lecturer', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Salah El Behery, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Heba Moahmed Fouad', 'investigatorAffiliation': 'Cairo University'}}}}