Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-01-27 @ 10:02 AM
Study NCT ID:
NCT02235532
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2014-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Aloe Vera Toothpaste on Periodontal Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2014-08-30', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measuring gingival index', 'timeFrame': '1-2days', 'description': 'to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.'}], 'secondaryOutcomes': [{'measure': 'measuring gingival index', 'timeFrame': '1-2 days', 'description': 'to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.'}, {'measure': 'measuring plaque index', 'timeFrame': '1-2 days', 'description': 'to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the plaque index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clinical trial', 'oral hygiene', 'Gingivitis', 'Aloevera', 'Toothpaste', 'anti-inflammatory agents'], 'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.\n\nThe single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days . This order was reversed in group 2.', 'detailedDescription': 'Toothpastes are used with tooth brushing to better control microbial plaque. Herbal toothpastes have recently gained attention. This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.\n\nThis single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days and then their plaque index (PI) and gingival index (GI) were recorded. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days and underwent PI and GI assessment again. This order was reversed in group 2. Wilcoxon-Sign Rank and two way Repeated Measure ANOVA tests were applied for statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects were selected among dental students with at least 20 natural teeth without systemic disease\n* No periodontal treatment at least 6 months to the study\n* No use of systemic antibiotic and anti-inflammatory drugs within the last 3 months, nonsmokers, no pregnancy or lactating women\n* Subjects with PD≤3mm, (clinical attachment level)CAL\\<1mm, PI≥2 and gingival bleeding in more than 30% of the tested areas were enrolled with the diagnosis of plaque-related gingivitis.\n\nExclusion Criteria:\n\n* Subjects with orthodontic appliances ,multiple bridges, partial denture, multiple caries were excluded from the study'}, 'identificationModule': {'nctId': 'NCT02235532', 'briefTitle': 'Effects of Aloe Vera Toothpaste on Periodontal Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Islamic Azad University, Sanandaj'}, 'officialTitle': 'Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients With Gingivitis', 'orgStudyIdInfo': {'id': 'IRCT2014040517053N2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foramen Herbal Aloe toothpaste', 'description': 'test group was asked to brush the teeth with Foramen Herbal Aloe toothpaste for 30 days once a day.', 'interventionNames': ['Other: Foramen Herbal Aloe toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'use of fluoride toothpaste (signal)', 'description': 'use of a fluoride toothpaste (signal) in control group once a day for 30 days .', 'interventionNames': ['Other: fluoride toothpaste']}], 'interventions': [{'name': 'Foramen Herbal Aloe toothpaste', 'type': 'OTHER', 'description': 'use of aloe-vera toothpaste for 30 days in the test group.', 'armGroupLabels': ['Foramen Herbal Aloe toothpaste']}, {'name': 'fluoride toothpaste', 'type': 'OTHER', 'otherNames': ['signal'], 'description': 'use of signal toothpaste once a day for 30 days in the control group.', 'armGroupLabels': ['use of fluoride toothpaste (signal)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19585175', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Tehran Dental Branch, Islamic azad University', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Ferena Sayar, DDS;MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran Dental Branch, Islamic Azad University,Tehran/Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Islamic Azad University, Sanandaj', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Ferena Sayar', 'investigatorAffiliation': 'Islamic Azad University, Sanandaj'}}}}