Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT04982302
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2021-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gut Microbial Changes After Periodontal Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D064806', 'term': 'Dysbiosis'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva and stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in microbiome alpha diversity measured from stool samples at 3 months', 'timeFrame': '[Time Frame: Baseline and 90 days]', 'description': 'Taxonomic and functional variation of gut bacteria after treatment'}], 'secondaryOutcomes': [{'measure': 'Changes in microbiome alpha diversity measured from saliva samples at 3 months', 'timeFrame': '[Time Frame: Baseline and 90 days]', 'description': 'Taxonomic and functional variation of salivary bacteria after treatment'}, {'measure': 'Changes in mean clinical attachment level (CAL) at 3 months', 'timeFrame': '[Time Frame: Baseline and 90 days]', 'description': 'Variation in CAL after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element'}, {'measure': 'Changes in periodontal pocket depth (PPD) at 3 months', 'timeFrame': '[Time Frame: Baseline and 90 days]', 'description': 'Variation in PPD after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element'}, {'measure': 'Changes in full mouth bleeding score (FMBS) at 3 months', 'timeFrame': '[Time Frame: Baseline and 90 days]', 'description': 'Variation in the percentage of bleeding sites after therapy assessed by gentle probing at 6 sites per tooth element'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis', 'Dysbiosis', 'Intestinal Disease']}, 'descriptionModule': {'briefSummary': "Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that non-surgical periodontal treatment may reduce bacterial alpha diversity in stool samples. Fifty patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and 3 months after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be consecutively selected among the patients diagnosed of Stage III-IV periodontitis at the Section of Periodontology of the C.I.R. Dental School of Turin.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* periodontitis Stage III or IV\n* BMI between 20 and 29 kg/m2\n* free diet\n* presence of at least 20 teeth\n\nExclusion Criteria:\n\n* systemic diseases (including diabetes, thyroid, liver, or kidney diseases)\n* dietary allergies\n* use of antibiotics or probiotics during the previous 30 days\n* pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT04982302', 'briefTitle': 'Gut Microbial Changes After Periodontal Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Evaluation of Salivary and Intestinal Microbiological Response in Patients With Stage III-IV Periodontitis After Non-surgical Periodontal Therapy', 'orgStudyIdInfo': {'id': 'Perio-gut connection'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-surgical periodontal treatment NSPT', 'description': 'Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets in 2 or 4 appointments', 'interventionNames': ['Procedure: Non-surgical periodontal treatment']}], 'interventions': [{'name': 'Non-surgical periodontal treatment', 'type': 'PROCEDURE', 'description': 'Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets', 'armGroupLabels': ['Non-surgical periodontal treatment NSPT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'CIR Dental School', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}