Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT05995158
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2023-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metagenomic Analysis of the Link Between Periodontitis and Smoking: Case-control Study
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'samples of the subgingival plaque'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oral microbiome composition by NGS sequencing using next generation sequencer', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Probing depth (mm) by periodontal probe', 'timeFrame': '1 month'}, {'measure': 'Bleeding on probing tested by a periodontal probe % of sites with bleeding on probing', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Condition, Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'Periodontitis is a widely prevalent disease worldwide that has serious public health consequences. Its prognosis includes tooth loss and edentulism, a condition that negatively affects chewing causing functional disability; and esthetics causing social impairment. Consequently, periodontitis may end up causing marked impairment of the quality of life of the affected patients, impairment of general health and increasing the dental care costs significantly.\n\nDysbiotic changes in the oral microbiome arise after some microbial species are enriched by primary products resulting from tissue breakdown due to gingivitis. It then triggers the host cells to produce proteinases that mediate loss of marginal periodontal ligaments, apical migration of the junctional epithelium and apical spread of bacterial biofilm.\n\nHowever, the dysbiotic changes may be more likely to occur in some patients rather than others due to certain risk factors including smoking and immuneinflammatory responses. Thus, the severity of periodontal disease in these patients would be higher. Tobacco smoking is no longer considered to be a habit, but a dependence to nicotine and a chronic relapsing medical disorder. Among its detrimental effects on general health, tobacco smoking increases the risk of periodontitis by 2 to 5 folds. This takes place by increasing the dysbiotic changes in the oral microbiome and so, increasing the severity and extent of the periodontal disease at a younger age. Therefore, smoking has been considered as a modifying factor of periodontitis that should be considered upon periodontitis case grading definition.\n\nTherefore, this research aims to identify the difference in dysbiosis between the three categories of periodontitis, trying to understand the cause of the resistance of each category to treatment compared to the milder category.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients clinically diagnosed to have chronic periodontitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years or older.\n* Patients with periodontitis.\n* Probing pocket depth ≥ 4 mm.\n* Teeth with CAL≥ 3 mm at ≥2 non-adjacent teeth.\n* Clinical indication and/or patient request for treatment of the periodontal condition.\n\nExclusion Criteria:\n\n* Patients with any systemic diseases.\n* Pregnant females.\n* Patients who took any antibiotic in the past month.\n* Handicapped and mentally retarded patients.\n* Patients undergoing radiotherapy.'}, 'identificationModule': {'nctId': 'NCT05995158', 'briefTitle': 'Metagenomic Analysis of the Link Between Periodontitis and Smoking: Case-control Study', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': 'Metagenomic Analysis of the Link Between Periodontitis and Smoking: Case-control Study', 'orgStudyIdInfo': {'id': '127-10-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smokers ≥ 10 cigarettes/day', 'description': 'metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)', 'interventionNames': ['Procedure: Metagenomic testing of the subgingival plaque samples']}, {'label': 'Smokers < 10 cigarettes/day', 'description': 'metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)', 'interventionNames': ['Procedure: Metagenomic testing of the subgingival plaque samples']}, {'label': 'non-smokers', 'description': 'metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)', 'interventionNames': ['Procedure: Metagenomic testing of the subgingival plaque samples']}], 'interventions': [{'name': 'Metagenomic testing of the subgingival plaque samples', 'type': 'PROCEDURE', 'description': 'sampling, extraction and sequencing of the oral microbiome in the samples', 'armGroupLabels': ['Smokers < 10 cigarettes/day', 'Smokers ≥ 10 cigarettes/day', 'non-smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21589', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz University', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Jazia A Alblowi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdulaziz University Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jazia Alblowi', 'investigatorAffiliation': 'King Abdulaziz University'}}}}