Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT02931734
Status:
COMPLETED
Last Update Posted:
2016-10-14
First Post:
2016-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500418', 'term': 'Clinpro Sealant'}, {'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of cervical dentin hypersensitivity, measured by visual analog scale', 'timeFrame': '24 weeks', 'description': 'Evaluate the reduction in Cervical Dentin Hypersensitivity with a 24 weeks follow up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypersensitivity Dentin', 'Dentin Sensitivity', 'Dentin Hypersensitivity', 'Dentine Hypersensitivity']}, 'referencesModule': {'references': [{'pmid': '7702459', 'type': 'BACKGROUND', 'citation': 'Orchardson R, Gangarosa LP Sr, Holland GR, Pashley DH, Trowbridge HO, Ashley FP, Kleinberg I, Zappa U. Dentine hypersensitivity-into the 21st century. Arch Oral Biol. 1994;39 Suppl:113S-119S. doi: 10.1016/0003-9969(94)90197-x. No abstract available.'}, {'pmid': '16687880', 'type': 'BACKGROUND', 'citation': 'Lussi A. Erosive tooth wear - a multifactorial condition of growing concern and increasing knowledge. Monogr Oral Sci. 2006;20:1-8. doi: 10.1159/000093343.'}, {'pmid': '24724135', 'type': 'BACKGROUND', 'citation': 'Davari A, Ataei E, Assarzadeh H. Dentin hypersensitivity: etiology, diagnosis and treatment; a literature review. J Dent (Shiraz). 2013 Sep;14(3):136-45.'}, {'pmid': '12662460', 'type': 'BACKGROUND', 'citation': 'Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.'}, {'pmid': '11203968', 'type': 'BACKGROUND', 'citation': 'Coleman TA, Grippo JO, Kinderknecht KE. Cervical dentin hypersensitivity. Part II: Associations with abfractive lesions. Quintessence Int. 2000 Jul-Aug;31(7):466-73.'}, {'pmid': '5218158', 'type': 'BACKGROUND', 'citation': 'Brannstrom M. Sensitivity of dentine. Oral Surg Oral Med Oral Pathol. 1966 Apr;21(4):517-26. doi: 10.1016/0030-4220(66)90411-7. No abstract available.'}, {'pmid': '22296690', 'type': 'BACKGROUND', 'citation': 'Grippo JO, Simring M, Coleman TA. Abfraction, abrasion, biocorrosion, and the enigma of noncarious cervical lesions: a 20-year perspective. J Esthet Restor Dent. 2012 Feb;24(1):10-23. doi: 10.1111/j.1708-8240.2011.00487.x. Epub 2011 Nov 17.'}, {'pmid': '23268573', 'type': 'BACKGROUND', 'citation': 'Grippo JO. Biocorrosion vs. erosion: the 21st century and a time to change. Compend Contin Educ Dent. 2012 Feb;33(2):e33-7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.', 'detailedDescription': "Cervical dentin hypersensitivity is a painful condition and is a clinical challenge due to different treatment strategies available. The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity. A hundred forty teeth of healthy patients of both sexes were selected. Visual Analog Scale was used pain (VAS) to measure the intensity of the patient's pain. The teeth will be randomly divided into 7 different groups according to the desensitization treatment under study: Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of dentin exposure lesions with clinical diagnosis of moderate or severe tooth sensitivity\n* good oral hygiene.\n\nExclusion Criteria:\n\n* cavities,\n* presence of periodontal disease and or parafunctional habits,\n* cracks or enamel fractures,\n* extensive or unsatisfactory restorations,\n* recent restorations involving the labial surface,\n* dentures,\n* orthodontics.'}, 'identificationModule': {'nctId': 'NCT02931734', 'acronym': 'CDH', 'briefTitle': 'Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Uberlandia'}, 'officialTitle': 'Analysis of the Association of Products for the Treatment of Cervical Dentin Hypersensitivity', 'orgStudyIdInfo': {'id': 'CAAE:35634614.2.0000.5152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Resin modified glass ionomer (RMGI)', 'description': 'Resin modified glass ionomer; an application every 48 hours; 4 sessions.', 'interventionNames': ['Drug: Resin modified glass ionomer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Potassium Nitrate 2% (KF)', 'description': 'Potassium Nitrate and Sodium fluoride 2%; an application every 48 hours; 4 sessions.', 'interventionNames': ['Drug: Potassium Nitrate 2%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low level laser therapy - GaAlAs (LLLT)', 'description': 'Low level laser therapy - GaAlAs; an application every 48 hours; 4 sessions.', 'interventionNames': ['Procedure: Low level laser therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RMGI and KF', 'description': 'Resin modified glass ionomer and potassium nitrate and sodium fluoride 2%; an application of the two associated products, every 48 hours; 4 sessions.', 'interventionNames': ['Drug: Resin modified glass ionomer', 'Drug: Potassium Nitrate 2%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RMGI and LLLT', 'description': 'Resin modified glass ionomer and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions.', 'interventionNames': ['Drug: Resin modified glass ionomer', 'Procedure: Low level laser therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KF and LLLT', 'description': 'Potassium Nitrate and Sodium fluoride 2% and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions.', 'interventionNames': ['Drug: Potassium Nitrate 2%', 'Procedure: Low level laser therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RMGI, KF, LLLT', 'description': 'Resin modified glass ionomer, potassium nitrate and sodium fluoride 2% and Low level laser therapy - GaAlAs ; an application of the three associated products, every 48 hours; 4 sessions.', 'interventionNames': ['Drug: Resin modified glass ionomer', 'Drug: Potassium Nitrate 2%', 'Procedure: Low level laser therapy']}], 'interventions': [{'name': 'Resin modified glass ionomer', 'type': 'DRUG', 'otherNames': ['Clinpro'], 'description': 'Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds', 'armGroupLabels': ['RMGI and KF', 'RMGI and LLLT', 'RMGI, KF, LLLT', 'Resin modified glass ionomer (RMGI)']}, {'name': 'Potassium Nitrate 2%', 'type': 'DRUG', 'otherNames': ['Desensibilize KF'], 'description': 'Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.', 'armGroupLabels': ['KF and LLLT', 'Potassium Nitrate 2% (KF)', 'RMGI and KF', 'RMGI, KF, LLLT']}, {'name': 'Low level laser therapy', 'type': 'PROCEDURE', 'otherNames': ['Photon Lase III'], 'description': 'Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.', 'armGroupLabels': ['KF and LLLT', 'Low level laser therapy - GaAlAs (LLLT)', 'RMGI and LLLT', 'RMGI, KF, LLLT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38400-000', 'city': 'Uberlândia', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Uberlandia', 'geoPoint': {'lat': -18.91861, 'lon': -48.27722}}], 'overallOfficials': [{'name': 'Paulo V Soares, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Uberlandia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Uberlandia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'PAULO VINICIUS SOARES', 'investigatorAffiliation': 'Federal University of Uberlandia'}}}}