Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT04723732
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2020-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D003773', 'term': 'Dental Plaque'}], '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'}, {'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': "IL-1β is an important mediator of the inflammatory response. Elevated IL-1β levels have been reported in a number of infectious disease conditions and in noninfectious inflammatory conditions. Human IL-1β ELISA kit by BioVendor was utilized to determine the IL-1β level. Preparation of reagents, execution of test protocol, and calculation of results were done adhering to the manufacturer's Product Data Sheet enclosed with the kit. The absorbance of each strip was read on a spectro-photometer at 450 nm wave length."}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 14', 'timeFrame': 'Baseline, Day 7, and Day 14', 'description': 'The MGI is a noninvasive visual assessment tool to assess the severity of gingivitis over time. It uses a rating score between 0 (normal gingiva) and 3 (severe inflammation with tendency to spontaneous bleeding). Change = (Day 14 Score - Baseline Score)'}, {'measure': "Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 14", 'timeFrame': 'Baseline, Day 7, and Day 14', 'description': 'The PI is a validated assessment tool based on recording of the presence of soft debris and mineralized deposits on all 4 surfaces of all teeth. It uses a rating score between 0 (no plaque) and 1 (plaque present at gingival margin). Change = (Day 14 Score - Baseline Score)'}, {'measure': 'Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': 'The GBI is a reliable indicator of gingival inflammation and periodontal stability. It uses gentle probing of the orifice of the gingival sulcus. The bleeding on probing (BOP) was assessed using a standardized periodontal probe with a 0.6 mm tip and 1 mm marking. A trained examiner measured BOP applying probing forces not exceeding 0.25 N (25 g). A positive finding was recorded if bleeding occured within 10 seconds.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gingivitis', 'herbal', 'myrrh', 'myrrha', 'antigingivitis', 'antiplaque', 'IL-1', 'dental plaque'], 'conditions': ['Gingivitis', 'Dental Plaque']}, 'descriptionModule': {'briefSummary': 'Myrrh-based mouthwash has the potential to be a suitable alternative to the gold standard chlorhexidine mouthwash for dental plaque and gingivitis reduction. To date, however, little research has been carried out to determine its true clinical significance on periodontal health. The purpose of this study is to evaluate and compare the efficacy of 1% myrrh mouthwash with commercially available 0.2% chlorhexidine mouthwash in terms of plaque and gingivitis reduction and inflammatory mediator (interleukin-1β) inhibition.', 'detailedDescription': 'This will be a single-center, triple-blinded, randomized, three-arm parallel, controlled trial in periodontally healthy adult volunteers (no clinical attachment loss and bleeding on probing \\< 10%). We will include all eligible patients seeking dental treatment at the center after gaining a written informed consent. After the initial dental screening and a session of professional teeth cleaning procedures, participants will be instructed to refrain from regular oral hygiene practices for 2 weeks to develop experimental gingivitis. Participants will then be randomly allocated to one of the three treatment groups \\[1:1:1\\] using a simple randomization method (i.e. computer-generated random numbers). They will be instructed to continue refrain from regular oral hygiene practices and use 10 ml of the assigned mouthwash twice daily for 1 minute. Treatment effect will be evaluated by comparing the baseline (day 0) and post-intervention (day 14) values of all clinical parameters (modified gingival index, plaque index, proinflammatory interleukin-1β biomarker, and Gingival Bleeding Index).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* good periodontal health;\n* dentition of ≥20 teeth and a minimum of 5 teeth per quadrant;\n* the absence of any systemic illness;\n* no history of oral prophylaxis in the past 6 months;\n* no relevant medical history that might compromise normal oral hygiene practice.\n\nExclusion Criteria:\n\n* pocket depth \\>3 mm\n* severe misalignment of teeth;\n* the presence of orthodontic appliances;\n* intake of antibiotic and/or anti-inflammatory medications within the past 6 months;\n* use of tobacco;\n* inability of comply with the study's appointment schedule;\n* pregnant or breast-feeding mothers."}, 'identificationModule': {'nctId': 'NCT04723732', 'briefTitle': 'Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': 'A Clinical Study Comparing the Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash With Chlorhexidine Mouthwash in a 14-Day Experimental Gingivitis Model', 'orgStudyIdInfo': {'id': '058-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myrrh mouthwash', 'description': '1% mouthwash of Commiphora myrrha made from resin extract. Participants will use 10 ml of the mouthwash twice daily for 14 days.', 'interventionNames': ['Drug: Myrrh mouthwash']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine Mouthwash', 'description': 'Commercial 0.2% Chlorhexidine gluconate mouthwash (Avalon Pharma, Riyadh). Participants will use 10 ml of the mouthwash twice daily for 14 days.', 'interventionNames': ['Drug: Chlorhexidine mouthwash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Commercial 0.9% sodium chloride solution (Pharmaceutical solutions industry, Jeddah). Participants will use 10 ml of the mouthwash twice daily for 14 days.', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Myrrh mouthwash', 'type': 'DRUG', 'otherNames': ['Commiphora myrrha mouthwash'], 'description': '1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.', 'armGroupLabels': ['Myrrh mouthwash']}, {'name': 'Chlorhexidine mouthwash', 'type': 'DRUG', 'otherNames': ['Chlorhexidine gluconate mouthwash', 'Avalon Avohex mouthwash'], 'description': '0.2% mouthwash solution of chlorhexidine gluconate.', 'armGroupLabels': ['Chlorhexidine Mouthwash']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Sodium Chloride solution'], 'description': '0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride)', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21589', 'city': 'Jeddah', 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'facility': 'King Abdul Aziz University', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Talal Zahid, M.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdulaziz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'talal zahid', 'investigatorAffiliation': 'King Abdulaziz University'}}}}