Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-17 @ 9:21 AM
Study NCT ID:
NCT02214095
Status:
TERMINATED
Last Update Posted:
2014-08-12
First Post:
2014-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucosamine Periodontal Adjunctive Therapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005944', 'term': 'Glucosamine'}, {'id': 'D007785', 'term': 'Lactose'}], 'ancestors': [{'id': 'D006595', 'term': 'Hexosamines'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'had been finished', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2014-07-08', 'studyFirstSubmitQcDate': '2014-08-11', 'lastUpdatePostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gingival crevicular fluid IL-1β level', 'timeFrame': '0-3 months', 'description': 'baseline and after three months of Glucosamine Sulphate administration'}], 'secondaryOutcomes': [{'measure': 'probing depth', 'timeFrame': '0-3 months', 'description': 'the distance from the gingival margin to the base of the pocket was measured at baseline and 3 months after drug administration'}, {'measure': 'clinical attachment level', 'timeFrame': '0-3 months', 'description': 'distance from cemento-enamel junction and base of the pocket was measured at baseline and 3 months after drug administration'}, {'measure': 'gingival index', 'timeFrame': '0-3 months', 'description': 'gingival inflammation was measured by gingival index at baseline and 3 months after drug administration.'}, {'measure': 'plaque index', 'timeFrame': '0-3 months', 'description': 'plaque deposits was measured by plaque index at baseline and 3 months after drug therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cytokines', 'interleukin-1β', 'chronic periodontitis', 'host modulation', 'glucosamine sulphate.'], 'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'This study is the first evidence based work evaluated the systemic use of glucosamine as an adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of patients with moderate to advanced chronic periodontitis', 'detailedDescription': 'Targeting the inflammatory response may be a rational approach to the medical treatment of chronic periodontitis. Glucosamine sulphate (GS) was proven to have anti-inflammatory actions with minimal side effect profile. Objectives; The main objectives of this study were to evaluate clinically the efficacy of GS; as a novel adjunctive host modulating agent in periodontal therapy and to investigate its effect on gingival crevicular fluid (GCF) level of IL-1β. Methods; Forty patients with moderate to severe chronic periodontitis (CP) were included in this study. They were randomly divided into two groups. Group I (G1) patients (n=20) received 500 mg GS capsules three times daily for 3 months following full mouth scaling and root planing (SRP), while group II (G2) patients (n=20) received a placebo for the same period following full mouth SRP. Clinical periodontal parameters and GCF IL-1β levels were analyzed at baseline and 3 months following therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. good compliance with the plaque control instructions following initial therapy\n2. each subject contributed a single premolar or molar tooth with interproximal probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm\n3. teeth involved were all vital with score 0-1 mobility\n4. availability for the follow-up and maintenance program;\n\nExclusion Criteria:\n\n1. no systemic diseases which could influence the outcome of therapy as evidenced by Burket's Oral Medicine health history questionnaire\n2. absence of periodontal treatment for the previous year\n3. absence of systemic medication or antibiotic treatment for the previous six months\n4. absence of a smoking habit.\n5. post menopausal, pregnant or breast feeding women were excluded from participating in the study. Patients with contraindications to glucosamine sulphate therapy e.g., hypersensitivity to any of the product's components or with inadequate compliance with the oral hygiene maintenance schedule were also excluded from the study."}, 'identificationModule': {'nctId': 'NCT02214095', 'briefTitle': 'Glucosamine Periodontal Adjunctive Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Glucosamine Sulphate as an Adjunctive Therapy to Closed Mechanical Debridement Reduced Gingival Cervicular Fluid IL-1β in Patients With Chronic Periodontitis', 'orgStudyIdInfo': {'id': 'randomized clinical trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'glucosamine sulphate capsules', 'description': '500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.', 'interventionNames': ['Drug: glucosamine sulphate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'lactose capsules', 'description': 'lactose capsules three times daily for 3 months', 'interventionNames': ['Drug: lactose capsules']}], 'interventions': [{'name': 'glucosamine sulphate', 'type': 'DRUG', 'otherNames': ['antiarthritis drugs', 'antiinflammatory drugs'], 'description': 'group I (G1) patients received 500 mg glucosamine sulphate capsules (Glucosamine Compound) , three times daily for 3 months following initial cause related therapy. Group II patients were given placebo capsules( Lactose) for the same period following initial cause related therapy', 'armGroupLabels': ['glucosamine sulphate capsules']}, {'name': 'lactose capsules', 'type': 'DRUG', 'armGroupLabels': ['lactose capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ainshams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmaed Y Gamal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ainshams University'}, {'name': 'Hala A Elela, professer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ainshams University'}, {'name': 'Mai S Attia, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of oral medicine and periodontology', 'investigatorFullName': 'Mai Shafik Attia', 'investigatorAffiliation': 'Ain Shams University'}}}}