Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT05215860
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2021-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062789', 'term': 'Tobacco Products'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The investigator who provided behavioural counselling to the participants was blinded to their clinical diagnosis of oral lesions'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective pilot interventional longitudinal study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2021-12-25', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Habit quit rates', 'timeFrame': '6 months', 'description': 'Discontinuation of habit more than 1 month.'}], 'secondaryOutcomes': [{'measure': 'Size of oral lesions', 'timeFrame': '6 months', 'description': 'Change in size of lesions from baseline in millimeters'}, {'measure': 'Oral burning sensation', 'timeFrame': '6 months', 'description': 'Change in oral burning sensation from baseline Visual Analogue Scale (VAS) scale 0-10; 0: No oral burning sensation; 10: Worst oral burning sensation'}, {'measure': 'Colour of oral lesions', 'timeFrame': '6 months', 'description': 'Change in colour of oral lesions from red to white'}, {'measure': 'Inter incisal mouth opening', 'timeFrame': '6 months', 'description': 'Change in interincisal mouth opening from baseline in millimeters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cessation', 'tobacco use', 'smokeless tobacco', 'areca', 'intraoral photography', 'abstinence'], 'conditions': ['Precancerous Conditions']}, 'descriptionModule': {'briefSummary': 'The success of tobacco and areca nut cessation programs in individuals with Oral Potentially Malignant Disorders (OPMDs) is imperative for risk reduction and prevention of oral cancer. A prospective pilot interventional study where 200 participants with current tobacco and areca nut habits and OPMD were randomly divided in two groups. Group A ( n=100; Habit cessation counselling with general and medical management for OPMD). Group B ( n=100; Habit cessation counselling with general and medical management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review).', 'detailedDescription': 'A prospective pilot interventional study was carried out in a Oral Medicine unit at a tertiary referral center where OPMD and Oral cancer screening is carried out routinely in all patients examined in the Out Patient Department (OPD). Ethical clearance for conducting the study and taking serial intraoral photographs of OPMD in consenting participants was obtained from the Institute Ethics Committee.All patients in OPD were initially screened for current habits of any form of tobacco and areca nut products through history and referred to the Tobacco Cessation Clinic (TCC) for individual counselling session.This counselling was based on the toolkit issued by the World Health Organization (WHO) for delivering brief tobacco intervention under WHO capacity building training package.The patients then underwent detailed intraoral examination for any oral mucosal changes. Those patients that were diagnosed as having any OPMD as per clinical diagnostic criteria were then recruited as participants in the study. A total of 200 participants with current tobacco and areca nut habits and OPMDs were recruited after informed written consent and randomly assigned to the two groups. The Control Group A had 100 participants who received standard management protocol for OPMD. The experimental Group B received all the management as in Control Group A but were also shown their intraoral photographs of oral lesions and explained about the areas of abnormalities that were of concern. All the participants were reviewed at 1, 3 and 6 months for surveillance of OPMD lesions and habit status.The data was analysed for statistically significant differences between the two groups p\\<0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current tobacco and areca nut users.\n* Presence of oral potentially malignant disorders\n\nExclusion Criteria:\n\n• Any oral lesion suspicious of malignancy.'}, 'identificationModule': {'nctId': 'NCT05215860', 'briefTitle': 'Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences'}, 'officialTitle': 'Visual Communication Through Personal Intraoral Photographs of Oral Potentially Malignant Disorders in Current Tobacco and Areca Nut Users Improves Habit Abstinence: a Pilot Interventional Study', 'orgStudyIdInfo': {'id': 'IEC-616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Habit cessation counselling with management for OPMD', 'description': 'n=100; Habit cessation counselling with general and medical management for OPMD', 'interventionNames': ['Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders']}, {'type': 'EXPERIMENTAL', 'label': 'Habit cessation counselling, management for OPMD and intraoral photographs', 'description': 'n=100; Habit cessation counselling with standard management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review', 'interventionNames': ['Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders', 'Other: visual exposure to personal intraoral photographs of oral lesions at baseline and review']}], 'interventions': [{'name': 'Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders', 'type': 'BEHAVIORAL', 'description': "WHO toolkit for Tobacco cessation (5A's and 5R's model)", 'armGroupLabels': ['Habit cessation counselling with management for OPMD', 'Habit cessation counselling, management for OPMD and intraoral photographs']}, {'name': 'visual exposure to personal intraoral photographs of oral lesions at baseline and review', 'type': 'OTHER', 'description': 'Chairside digital intraoral photographs of oral potentially malignant disorder with smart phone and showing the photograph to the participant explaining the abnormal areas of concern', 'armGroupLabels': ['Habit cessation counselling, management for OPMD and intraoral photographs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Oral Medicine and Radiology, CDER, AIIMS', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Shalini Gupta, MDS,FDSRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'All India Institute of Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'after publication in journal for a period of 12 months', 'ipdSharing': 'YES', 'description': 'The study data can be made available on request via email to principal investigator', 'accessCriteria': 'email of principal investigator shalinigupta@hotmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Additional Professor', 'investigatorFullName': 'Dr. Shalini Gupta', 'investigatorAffiliation': 'All India Institute of Medical Sciences'}}}}