Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT02930356
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2016-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tooth Cleaning in Smokers and Non Smokers With Gum Disease.
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': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2016-10-10', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome of the study was to measure plasma heaptocyte growth factor level', 'timeFrame': 'baseline, 3 months', 'description': 'The change in plasma hepatocyte growth factor level was measured at baseline and at the end of 3 months after scaling and root planing.2 ml blood was drawn from the patient to assess the hepatocyte growth factor levels.biochemical analysis was done by ELISA test i.e., blood samples from both smokers and non smokers with chronic periodontitis were taken at baseline and at the end of 3 monthd'}], 'secondaryOutcomes': [{'measure': 'gingival index', 'timeFrame': 'baseline and 3 months', 'description': 'The secondary outcome of the study is to measure gingival index at baseline and 3 months after scaling and root planing. gingival index was assesed using williams periodontal probe'}, {'measure': 'periodontal index', 'timeFrame': 'baseline and 3 months', 'description': 'The secondary outcome of the study is to measure periodontal index at baseline and 3 months after scaling and root planing. periodontal index was assesed using williams periodontal probe'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Periodontitis']}, 'referencesModule': {'references': [{'pmid': '25389376', 'type': 'BACKGROUND', 'citation': 'Anil S, Vellappally S, Preethanath RS, Mokeem SA, AlMoharib HS, Patil S, Chalisserry EP, Al Kheraif AA. Hepatocyte growth factor levels in the saliva and gingival crevicular fluid in smokers with periodontitis. Dis Markers. 2014;2014:146974. doi: 10.1155/2014/146974. Epub 2014 Oct 15.'}, {'pmid': '21976839', 'type': 'BACKGROUND', 'citation': 'Rudrakshi C, Srinivas N, Mehta DS. A comparative evaluation of hepatocyte growth factor levels in gingival crevicular fluid and saliva and its correlation with clinical parameters in patients with and without chronic periodontitis: A clinico-biochemical study. J Indian Soc Periodontol. 2011 Apr;15(2):147-51. doi: 10.4103/0972-124X.84384.'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to measure hepatocyte growth factor levels in smokers and non smokers with periodontitis before and after non surgical periodontal therapy.', 'detailedDescription': 'The study was randomised prospective,interventional clinical trial. The sample size for the study was 40 individuals aged between 20 to 60 years,equally divided into two groups.\n\nGroup l - smokers with chronic periodontitis (test) group. Group ll - non smokers with chronic periodontitis (controls)\n\nAt baseline both the groups were analysed for clinical and biochemical parameters and underwent non surgical periodontal therapy( scaling and root planning). All parameters were reassesed after 3 months.\n\nA total of 40 patients( 20 somkers and 20 non smokers) from the outpatient wing of department of periodontics, Panineeya mahavidyalaya institute of dental sciences and research centre diagnosed with chronic periodontitis and willing to participate in the study.\n\nClicical parameters included gingival index and periodontal index. Biochmeical parameters included plasma hepatocyte growth factor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* probing depth \\>4mm\n* clinical attachment loss\\>2mm\n\nExclusion Criteria:\n\n* patients younger than 20 years and greater than 60 years\n* presence of any chronic conditions like diabetes,infections\n* antibiotic therapy received preceeding 3 months\n* former smokers who had quit the habit of smoking\n* patients who already underwent periodontal therapy'}, 'identificationModule': {'nctId': 'NCT02930356', 'acronym': 'ETCSNSGD', 'briefTitle': 'Effect of Tooth Cleaning in Smokers and Non Smokers With Gum Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}, 'officialTitle': 'Effects of Nonsurgical Periodontal Therapy on Plasma Hepatocyte Growth Factor Levels in Smokers and Non Smokers With Chronic Periodontitis', 'orgStudyIdInfo': {'id': 'D149206028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NSPT-Test group', 'description': 'NSPT was done after administration of pre procedural mouth rinse in the test group (20 smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to asses the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.', 'interventionNames': ['Other: NSPT']}, {'type': 'EXPERIMENTAL', 'label': 'Scaling and root planing-Control group', 'description': 'Scaling and root planing was done after administration of pre procedural mouth rinse in the control group (20 non smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to asses the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.', 'interventionNames': ['Other: Scaling and root planing']}], 'interventions': [{'name': 'NSPT', 'type': 'OTHER', 'description': 'NSPT was done by ultrasonic scalers after administration of pre procedural mouth rinse in the test group (20 smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to assess the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.', 'armGroupLabels': ['NSPT-Test group']}, {'name': 'Scaling and root planing', 'type': 'OTHER', 'description': 'Scaling and root planing was done by ultrasonic scalers after administration of pre procedural mouth rinse in the control group (20 non smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to assess the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.', 'armGroupLabels': ['Scaling and root planing-Control group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dr.Veerendranath R Panthula, MDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PG STUDENT', 'investigatorFullName': 'C.BHARGAVI', 'investigatorAffiliation': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}}}}