Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 5:04 AM
Study NCT ID:
NCT04259034
Status:
UNKNOWN
Last Update Posted:
2020-02-11
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periodontal Status in Oral Lichen Planus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-08', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical attachment level', 'timeFrame': '6 months', 'description': 'CAL will be measured from cementoenamel junction to the base of the pocket using a periodontal probe at 6 sites'}], 'secondaryOutcomes': [{'measure': 'Bleeding on probing', 'timeFrame': '6 months', 'description': 'BOP will be measured using a periodontal probe at 4 sites'}, {'measure': 'PLAQUE INDEX', 'timeFrame': '6 months', 'description': 'PI will be measured using a periodontal probe at 4 sites'}, {'measure': 'Gingival index', 'timeFrame': '6 months', 'description': 'Gingival index will be measured using a periodontal probe at 4 sites'}, {'measure': 'Probing pocket depth', 'timeFrame': '6 months', 'description': 'Probing pocket depth will be measured from gingival margin to the base of the pocket using a periodontal probe at 6 sites'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The aim is to investigate the influence of oral lichen planus on periodontal status of systemically healthy individuals.', 'detailedDescription': 'Lichen planus, a chronic immune-mediated inflammatory disease affects the skin and mucous membranes. Oral lichen planus is the mucosal counterpart of cutaneous lichen planus. It was reported first described in 1866 as white papular eruptions in the oral cavity. The prevalence of OLP varies from 0.1% to 4%. OLP mostly occurs in middle aged and elderly patients, with female to male ratio of 3:2. OLP is characterized by lesions consisting of radiating white, grey, velvety, thread-like papules in a linear, annular and retiform arrangement forming typical lacy, reticular patches, rings and streaks. The lesions are most common on buccal mucosa, tongue, lips, gingiva, floor of mouth, palate. Clinically OLP has six clinical presentations namely reticular, erosive, atrophic, plaque-like, papular, bullous.\n\nReticular form, the most common clinical form presents as fine, asymptomatic intertwined lace-like pattern called "Wickham striae" in a bilateral symmetrical form. It mainly involves the posterior mucosa of the cheek. Erosive OLP represents symptomatic lesions. Atrophic lesions may resemble the combination of two clinical forms, such as the presence of white striae characteristic of the reticular type surrounded by an erythematous area. Plaque-like form mainly found on dorsum of the tongue and the mucosa of the cheek reveals whitish homogeneous irregularities similar to leukoplakia. Papular form presents with small white papules with fine striae in its periphery. Bullous form is the most unusual clinical form, exhibiting blisters that increase in size and tend to rupture, leaving the surface ulcerated and painful.\n\nThe pathogenesis of the disease is characterized by cytotoxic CD8+ T lymphocytes migration to the epithelium inducing apoptosis of basal keratinocytes. A number of etiological factors in OLP have been proposed such as local and systemic inducers of cell-mediated hypersensitivity, drugs, dental materials, infectious agents, and stress. The existence of a local cell-mediated immune disorder has been postulated as a factor underlying development of the lesions specifically, a delayed cellular hypersensitivity response probably triggered by some exogenous agent. Periodontal diseases are the most prevalent oral microbial infections that lead to chronic inflammation of the supporting tissues of teeth. Periodontal disease has a complex pathogenesis involving host microbiome interactions. It has an impact on both local and systemic health. The pathogenesis of periodontal disease involves a local inflammatory reaction and the activation. Thus, it is possible to speculate that some interference could exist and that the potential effect arising from these shared mechanisms⁄ mediators could be localized to sites where OLP lesions are present and alteration of host immune response in OLP may have an impact on periodontal health. With this consideration, the present study is aimed to assess periodontal status in systemically healthy individuals with and without oral lichen planus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'systemically healthy individuals with and without oral lichen planus', 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals aged 40-50 yrs. Clinically diagnosed and histo-pathologically confirmed cases of oral Lichen Planus\n\nExclusion Criteria:\n\nHistory of periodontal therapy in last one year. Drug-induced lichenoid reaction or any other red or white lesions in the oral cavity.\n\nThe presence of any tooth restoration near the lesions. Smokers or patients with history of smoking. systemic diseases or conditions that are reported to be associated with periodontal diseases, including diabetes mellitus, osteoporosis, rheumatoid arthritis Pregnant and lactating women. Patients with history of systemic treatment for oral Lichen Planus Patients with cutaneous lichen planus'}, 'identificationModule': {'nctId': 'NCT04259034', 'briefTitle': 'Periodontal Status in Oral Lichen Planus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Assessment of Periodontal Status in Patients With Oral Lichen Planus', 'orgStudyIdInfo': {'id': 'RMA PGIDS/IEC/2019/32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'systemically healthy individuals with oral lichen planus', 'description': 'systemically healthy individuals diagnosed with oral lichen planus on clinical and histopathological basis.', 'interventionNames': ['Other: diagnosis of periodontitis in oral lichen planus patients']}, {'label': 'systemically healthy individuals without oral lichen planus', 'description': 'systemically healthy individuals without any clinical feature of oral lichen planus.', 'interventionNames': ['Other: diagnosis of periodontitis in systemically healthy individuals without oral lichen planus']}], 'interventions': [{'name': 'diagnosis of periodontitis in oral lichen planus patients', 'type': 'OTHER', 'description': 'diagnosis of periodontitis in oral lichen planus patients', 'armGroupLabels': ['systemically healthy individuals with oral lichen planus']}, {'name': 'diagnosis of periodontitis in systemically healthy individuals without oral lichen planus', 'type': 'OTHER', 'description': 'diagnosis of periodontitis in systemically healthy individuals without oral lichen planus', 'armGroupLabels': ['systemically healthy individuals without oral lichen planus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Narula', 'role': 'CONTACT', 'email': 'scnarula@gmail.com', 'phone': '01262283876'}], 'facility': 'Post Graduate Institute of Dental Sciences', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}], 'centralContacts': [{'name': 'Satish Narula, MDS', 'role': 'CONTACT', 'email': 'scnarula@gmail.com', 'phone': '01262283876'}, {'name': 'TEWARI, MDS', 'role': 'CONTACT', 'email': 'principalpgids@yahoo.in', 'phone': '01262283876'}], 'overallOfficials': [{'name': 'RMA ARYA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'study protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}