Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT03475394
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2018-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-03-22', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the periodontal pocket depth', 'timeFrame': '45 days', 'description': 'Measured by Probing pocket depth'}], 'secondaryOutcomes': [{'measure': 'Reduction in the Microbial count of periodontal pathogens', 'timeFrame': '45 days', 'description': 'Reduction in Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia'}, {'measure': 'Reduction in Plaque deposition', 'timeFrame': '45 days', 'description': 'Measured by Plquel index (Silness and Loe)'}, {'measure': 'Reduction in gingival inflammation', 'timeFrame': '45 days', 'description': 'Measured by Gingival index (Loe and Silness)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chlorhexidine gluconate', 'Morus alba', 'Microbiology', 'Gel', 'Root planing'], 'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'Background: Periodontitis is a chronic inflammatory disease of tooth and supporting tissues with clinical signs of bone and connective tissue loss and is mediated by a combination of periodontal pathogens and host defense systems. Currently the use of herbal products in dentistry is increasing due to their easy availability, low cost and lesser side effects. One such herbal plant is Morus alba which is known to possess medicinal properties. Therefore the present study was conducted to determine the clinical effectiveness of subgingivally delivered Morus alba gel incorporated into polaxamers vehicle for its controlled release on periodontal pocket in adjunct to scaling and root planing for treatment of moderate periodontitis patients.\n\nMethods: one hundred eighty patients with chronic periodontitis having pocket depth of ≥5 mm in atleast two different teeth were treated by full-mouth scaling and root planning (SRP) and curettage. They were randomly assigned into one of the three groups with 60 in each group: Group 1: Chlorhexidine Sol-gel was applied at baseline, 15 and 30 days. Group 2: Morus alba Sol-gel was applied at baseline, 15 and 30 days. Grpup 3: Placebo gel was applied at baseline, 15 and 30 days. Plaque index (PI) (Silness and Loe), Gingival index (GI) (Loe and Silness), Community Periodontal index, Periodontal pocket depth and quantitative analysis (anaerobic culture) of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia were assessed at baseline and after 45 days.', 'detailedDescription': 'Morus alba is invaluable member of the plant kingdom belonging to the family Moraceae and the genus Morus. It is extensively cultivated for leaf yield in sericulture. Morus alba have long been used in traditional medicine to improve eyesight, lower blood pressure, prevent diabetes, protect the liver, strengthen joints and treat fever. In particular, few studies on mulberry fruits have reported its biological activities such as antioxidative and anti-inflammatory activities. Even the root bark of has been traditionally used in Asian countries for medicinal purposes due to its anti-inflammatory, hypoglycemic, antibacterial activities. LD50 of extracts of Morus Alba leaves was found to be above 2000 mg/kg which is safe to be used in human beings. Therefore, in the present study the Morus alba leaves has been used in the gel preparation and its effectiveness is assessed against periodontal microorganisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 35 to 55 years old\n2. untreated moderate chronic periodontitis having probing pocket depth of ≥5 mm in atleast two different teeth\n\nExclusion Criteria:\n\n1. use of antibiotics or anti-inflammatory drugs during the last 6 months before baseline examination\n2. Received periodontal treatment in the last 6 months\n3. pregnant or lactating\n4. allergy to chlorhexidine or any of the components in the tested products\n5. using tobacco products in any form\n6. systemic diseases (e.g., diabetes mellitus, hypertension and immunological disorders)\n7. ) orthodontic treatment\n8. alcoholics\n9. removable prostheses\n10. Healthy with a normal BMI'}, 'identificationModule': {'nctId': 'NCT03475394', 'briefTitle': 'Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'KLE VK Institute of Dental Sciences'}, 'officialTitle': 'Comparison of Effectiveness of Morus Alba and Chlorhexidine Gels on Moderate Periodontitis Among 35 to 55 Year Old Subjects: A Hospital Based Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KLEU/Ethic/14-15/D-79'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 (Chlorhexidine gel)', 'description': 'Non surgical periodontal treatment at baseline and 0.1 ml of 1% chlorhexidine gel administered in subsequent visits.', 'interventionNames': ['Other: Chlorhexidine gel']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Morus alba gel)', 'description': 'Non surgical periodontal treatment at baseline and 0.1 ml of 16% Morus alba gel administered in subsequent visits.', 'interventionNames': ['Other: Morus alba gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3 (Placebo)', 'description': 'Non surgical periodontal treatment at baseline and 0.1 ml of placebo gel administered in subsequent visits.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Chlorhexidine gel', 'type': 'OTHER', 'description': '0.1 ml of Chlorhexidine gel was administered into the periodontal pocket', 'armGroupLabels': ['Group 1 (Chlorhexidine gel)']}, {'name': 'Morus alba gel', 'type': 'OTHER', 'description': '0.1 ml of Morus alba gel was administered into the periodontal pocket', 'armGroupLabels': ['Group 2 (Morus alba gel)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '0.1 ml of Placebo gel was administered into the periodontal pocket', 'armGroupLabels': ['Group 3 (Placebo)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KLE VK Institute of Dental Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Shilpa Gunjal', 'investigatorAffiliation': 'KLE VK Institute of Dental Sciences'}}}}