Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-07 @ 7:35 PM
Study NCT ID:
NCT02764060
Status:
COMPLETED
Last Update Posted:
2016-05-06
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Tongue Cleaning in Periodontitis 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': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-03', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extension of the tongue coating', 'timeFrame': '14 days', 'description': 'Extension of the tongue coating measured according to Miyazaki (1995) and Winkel (2003).'}], 'secondaryOutcomes': [{'measure': 'Bacterial load measured by culturing methods', 'timeFrame': '14 days', 'description': 'Microbiological composition of the tongue coating.'}, {'measure': 'Bacterial load measured by means of qPCR', 'timeFrame': '14 days', 'description': 'Microbiological composition of the tongue coating.'}, {'measure': 'Bacterial composition of unstimulated saliva (measured with the aid of culturing methods)', 'timeFrame': '14 days', 'description': 'Microbiological composition of the saliva.'}, {'measure': 'Bacterial composition of unstimulated saliva (measured with qPCR)', 'timeFrame': '14 days', 'description': 'Microbiological composition of the saliva.'}, {'measure': 'Experience of the subject of tongue coating related factors measured using a questionnaire', 'timeFrame': '14 days', 'description': 'Experience of the subject of the breath odour, taste perception; and cleanliness of the tongue.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Periodontitis', 'Tongue coating', 'Tongue cleaning', 'Bacterial load'], 'conditions': ['Periodontitis', 'Tongue Coating']}, 'referencesModule': {'references': [{'pmid': '15191584', 'type': 'BACKGROUND', 'citation': 'Quirynen M, Avontroodt P, Soers C, Zhao H, Pauwels M, van Steenberghe D. Impact of tongue cleansers on microbial load and taste. J Clin Periodontol. 2004 Jul;31(7):506-10. doi: 10.1111/j.0303-6979.2004.00507.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to examine in periodontitis patients with visible tongue coating the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper versus the use of a regular toothbrush to clean the tongue.', 'detailedDescription': "Volatile sulphur compounds (VSC's) are the most important causes of bad breath. Since the micro-organisms that produce VSC's are also periodopathogens, intuitively, one would think that there is a positive correlation between VSC levels in exhaled breath and periodontitis. However, not all periodontitis patients have bad breath. A possible explanation can be a positive relationship between tongue coating an bad breath. In the past, tongue cleaning was already researched in an oral healthy population. This research aimed to examine in periodontitis patients with visible tongue coating the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper versus the use of a regular toothbrush to clean the tongue. Additionally changes in tongue coating; and patient perception about tongue cleaning was researched."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy patients\n* periodontitis patients\n\nExclusion Criteria:\n\n* already using a tongue cleaning device\n* use of antibiotics the previous 6 months\n* rinsing with a chlorhexidine mouth rinse the past month\n* smokers\n* patients who underwent periodontal therapy the past three years were not included.'}, 'identificationModule': {'nctId': 'NCT02764060', 'briefTitle': 'The Effect of Tongue Cleaning in Periodontitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'The Effect of Tongue Scraping Compared to Tongue Cleaning on the Tongue Coating of Periodontitis Patients', 'orgStudyIdInfo': {'id': 's54161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tongue scraper', 'description': 'In this group the subjects are explained how to use a plastic loop-formed tongue cleaner (Halita® tongue cleaner (Dentaid, Spain)) to clean their tongues.', 'interventionNames': ['Device: Tongue scraper']}, {'type': 'EXPERIMENTAL', 'label': 'Toothbrush', 'description': 'In this group the subjects are explained how to use a toothbrush (Oral-B® Indicator® medium tooth brush) to clean their tongues.', 'interventionNames': ['Device: Toothbrush']}], 'interventions': [{'name': 'Tongue scraper', 'type': 'DEVICE', 'otherNames': ['Tongue scraper (Halita® tongue cleaner (Dentaid, Spain))'], 'description': 'The patients were instructed to start cleaning the tongue by two pulling strokes along the median sulcus of the tongue, followed by two pulling strokes along the lateral edges of the tongue.', 'armGroupLabels': ['Tongue scraper']}, {'name': 'Toothbrush', 'type': 'DEVICE', 'otherNames': ['Toothbrush (Oral-B® Indicator® medium tooth brush)'], 'description': 'The patients who were assigned to the tooth brush group were taught to perform three forward and backward strokes along the median sulcus and at each lateral part of the tongue.', 'armGroupLabels': ['Toothbrush']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZLeuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Marc Quirynen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'marc.quirynen@uzleuven.be'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}