Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-01-28 @ 8:36 AM
Study NCT ID:
NCT02767050
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2016-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Caries in Smoking and Smokeless Tobacco
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 613}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2016-05-06', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental caries in smoking and smokeless tobacco chewers is determined by proper clinical examination of caries and is scored by DMFT index in both smoking and smokeless tobacco chewers separately and measured.', 'timeFrame': '5-6 MONTHS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DENTAL CARIES', 'TOBACCO USERS', 'SMOKERS', 'SMOKELESS TOBACCO CHEWERS'], 'conditions': ['DENTAL CARIES']}, 'referencesModule': {'references': [{'pmid': '18661810', 'type': 'RESULT', 'citation': 'Vellappally S, Jacob V, Smejkalova J, Shriharsha P, Kumar V, Fiala Z. Tobacco habits and oral health status in selected Indian population. Cent Eur J Public Health. 2008 Jun;16(2):77-84. doi: 10.21101/cejph.a3448.'}, {'pmid': '17958204', 'type': 'RESULT', 'citation': 'Vellappally S, Fiala Z, Smejkalova J, Jacob V, Shriharsha P. Influence of tobacco use in dental caries development. Cent Eur J Public Health. 2007 Sep;15(3):116-21. doi: 10.21101/cejph.a3431.'}, {'pmid': '21731272', 'type': 'RESULT', 'citation': 'Rooban T, Vidya K, Joshua E, Rao A, Ranganathan S, Rao UK, Ranganathan K. Tooth decay in alcohol and tobacco abusers. J Oral Maxillofac Pathol. 2011 Jan;15(1):14-21. doi: 10.4103/0973-029X.80032.'}]}, 'descriptionModule': {'briefSummary': 'The following observational study evaluates incidence of caries in smoking and smokeless tobacco based on habit history by clinical examination and DMFT index.', 'detailedDescription': 'Dental caries is an irreversible microbial disease of the calcified tissues of the teeth, characterized by demineralization of the inorganic portion and destruction of the organic substance of the tooth, which often leads to cavitation. It is a complex and dynamic process where a multitude of factors influence and initiate the progression of disease. There are practically no geographic areas in the world whose inhabitants do not exhibit some evidence of dental caries. It affects persons of both genders in all races, all socioeconomic strata and every age group. Likewise, there is strong evidence that tobacco use has numerous negative effects on oral health, for example staining of teeth, dental restoration, development of oral diseases. A biologically reasonable explanation for an association between chewing tobacco use and dental caries may be the presence of higher levels of fermentable sugars in chewing tobacco products which can stimulate the growth of carcinogenic bacteria. The decreased buffering effect possible lower pH of smokers saliva and higher number of lactobacilli and streptococcus mutans group may indicate an increased susceptibility to caries in smokers. On the other hand, there are researches which conclude that presence of extrinsic tobacco stains appear to provide a protective effect from caries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending Panineeya Institute of Dental Sciences and Research Centre having tobacco chewing and smoking habits without fluorosis would be included in the study after their informed consent.\n\nDMFT index is scored for 613 patient of both the genders, visiting OPD of oral medicine and radiology after the clinical diagnosis of caries along with radiographs. The clinical scores are recorded along with investigations and a proforma would include the habit with duration, frequency, area of placement and form of tobacco intake.', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Patients who are willing for the study.\n* A positive history of dental caries in smokers and smokeless tobacco.\n* Patients with caries not under any treatment of the same.\n\nEXCLUSION CRITERIA:\n\n* Unwilling patients who do not want to be a part of the study.\n* Patient with fluorosis.'}, 'identificationModule': {'nctId': 'NCT02767050', 'acronym': 'ICSSLT', 'briefTitle': 'Incidence of Caries in Smoking and Smokeless Tobacco', 'organization': {'class': 'OTHER', 'fullName': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}, 'officialTitle': 'Incidence of Caries in Smoking and Smokeless Tobacco-An Observation Study', 'orgStudyIdInfo': {'id': 'PMVIDS&RC/IEC/OMR/PR/0046-15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GROUP 1: CONTROL GROUPS', 'description': 'Patients with no habit history of tobacco are included in group 1.'}, {'label': 'GROUP 2: SMOKING TOBACCO', 'description': 'Patients with a history of tobacco consumption in the form of smoking.'}, {'label': 'GROUP 3: SMOKELESS TOBACCO', 'description': 'Patients with a history of tobacco consumption in the form of chewing.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '500060', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Panineeya Institute of Dental Sciences', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'overallOfficials': [{'name': 'NALLAN CHAITANYA, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Panineeya Mahavidhyalaya 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': 'Resident', 'investigatorFullName': 'Dr.Alekhya', 'investigatorAffiliation': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}}}}