Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-04 @ 11:24 AM
Study NCT ID:
NCT03851757
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2019-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cleansing Efficacy of Waist-shaped Interdental Brushes.
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-10', 'size': 203320, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-20T04:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomised, controlled, examiner-blinded, two-period crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2019-01-31', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turesky modification of the Quigley and Hein Plaque Index', 'timeFrame': '11 weeks', 'description': 'This is a plaque index scored as 0 = no plaque; 1 = slight flecks of plaque at the cervical margin of the tooth; 2 = a thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3 = a band of plaque wider than 1 mm but covering \\< 1/3 of the crown of the tooth; 4 = plaque covering at least 1/3 but \\< 2/3 of the crown of the tooth or 5 = plaque covering 2/3 or more of the crown of the tooth. A higher grade is worse (more plaque) than a lower grade. After measuring plaque grades on four sites per tooh, the mode is calculated, which is defined as the plaque grade most often measured in an individual.'}], 'secondaryOutcomes': [{'measure': 'papillary bleeding index by Saxer and Mühlemann', 'timeFrame': '11 weeks', 'description': 'A periodontal probe is inserted into the gingival sulcus at the line angle on the mesial and distal aspect of the papilla and then moved coronally to the papilla tip (score 0 - no bleeding; score 1 - a single discreet bleeding point; score 2 - several isolated bleeding points or a single line of blood; score 3 - the interdental triangle fills with blood; score 4 - profuse bleeding occurs after probing and flows immediately into the marginal sulcus). A higher bleeding grade is worse (more inflammed tissues) than a lower grade. After measuring papillary bleeeding grades on four sites per tooh, the mode is calculated, which is defined as the papillary bleeding grade most often measured in an individual.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biofilm', 'interdental brushes', 'interproximal', 'oral hygiene', 'periodontal disease(s)/periodontitis'], 'conditions': ['Periodontitis, Adult']}, 'referencesModule': {'references': [{'pmid': '22146002', 'type': 'BACKGROUND', 'citation': 'Chongcharoen N, Lulic M, Lang NP. Effectiveness of different interdental brushes on cleaning the interproximal surfaces of teeth and implants: a randomized controlled, double-blind cross-over study. Clin Oral Implants Res. 2012 May;23(5):635-40. doi: 10.1111/j.1600-0501.2011.02387.x. Epub 2011 Dec 6.'}, {'pmid': '5264376', 'type': 'BACKGROUND', 'citation': 'Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.'}, {'pmid': '351174', 'type': 'BACKGROUND', 'citation': 'Saxer UP, Turconi B, Elsasser C. Patient motivation with the papillary bleeding index. J Prev Dent. 1977 Jul-Aug;4(4):20-2. No abstract available.'}, {'pmid': '31609489', 'type': 'DERIVED', 'citation': 'Schnabl D, Goebel G, Kadletz A, Gaenzer H, Steiner R, Laimer J, Kapferer-Seebacher I. Cleansing efficacy of waist-shaped inter-dental brushes. A randomized-controlled crossover study. J Clin Periodontol. 2020 Jan;47(1):30-35. doi: 10.1111/jcpe.13210. Epub 2019 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present randomized and single-blinded cross-over study was to compare the cleansing efficacy of waist-shaped interdental brushes with that of cylindric interdental brushes in interproximal sites.', 'detailedDescription': 'Brushing efficacy of cylindric and waist-shaped interdental brushes was evaluated in a randomized, controlled, examiner-blinded, two-period crossover study. 20 periodontal maintenance patients of the University Hospital of Dental Prosthetics and Restorative Dentistry were recruited. Each subject was asked to attend three appointments. In the first visit (day one), baseline plaque and bleeding indices were assessed. Each proband was instructed by the same experienced dental hygienist with two sizes of waist-shaped and cylindric interdental brushes, respectively. Primary outcome measure plaque index and secondary outcome measure papillary bleeding index were assessed by two blinded and calibrated examiners at four sites per tooth.The odds ratio and confidence interval for establishing plaque free interdental sites were calculated with logistic regression analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Periodontitis stage 3\n* Completion of active periodontal treatment\n* Maximum probing pocket depths of 5 mm\n* No site ≥ 4 mm with bleeding on probing\n* Bleeding on probing \\< 10%\n* Open interproximal spaces both, in mandible and maxilla\n* Presence of \\> 23 natural teeth with no need for prosthetic rehabilitation.\n\nExclusion Criteria:\n\n* Oral or systemic diseases other than Periodontitis\n* Mucosal / periodontal swelling or Suppuration\n* Pregnancy\n* Minority\n* Need for frequent drug consumption'}, 'identificationModule': {'nctId': 'NCT03851757', 'acronym': 'Waist-shaped', 'briefTitle': 'Cleansing Efficacy of Waist-shaped Interdental Brushes.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Cleansing Efficacy of Waist-shaped Interdental Brushes. A Randomized-controlled Crossover Study.', 'orgStudyIdInfo': {'id': 'AN5123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'waist-shaped interdental brush', 'description': 'waist-shaped interdental brush, use four times per interdental space', 'interventionNames': ['Device: waist-shaped interdental brush']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cylindric interdental brush', 'description': 'cylindric interdental brush, use four times per interdental space', 'interventionNames': ['Device: cylindric interdental brush']}], 'interventions': [{'name': 'waist-shaped interdental brush', 'type': 'DEVICE', 'otherNames': ['Brand name: Circum Topcaredent'], 'description': 'use four times each per interdental space', 'armGroupLabels': ['waist-shaped interdental brush']}, {'name': 'cylindric interdental brush', 'type': 'DEVICE', 'otherNames': ['Brand name: Topcaredent'], 'description': 'use four times each per interdental space', 'armGroupLabels': ['cylindric interdental brush']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Ines Kapferer-Seebacher, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Innsbruck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}