Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 11:38 AM
Study NCT ID:
NCT03237793
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009050', 'term': 'Fluorosis, Dental'}, {'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}, {'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A unified stratified randomization, double blind controlled parallel designed was the type generated the allocation sequence. A skilled assistant enrolled the participants and assigned the participants to interventions.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The present study was designed as a randomised controlled clinical trial which was unicenter, double-blinded, parallel designed study, according to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-07', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-30', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in hypersensitivity', 'timeFrame': '30 minutes', 'description': 'The primary outcome that was assessed in the study was the reduction in dentinal hypersensitivity sensation. The visual analogue scale was used as a recording scale when tested with the tests for hypersensitivity, which were the testing with a blast of air, ice cold water testing and electrical tactile sensitivity testing using a scratch-o-meter.'}], 'secondaryOutcomes': [{'measure': 'use of diode laser in reducing hypersensitivity', 'timeFrame': '30 mins', 'description': 'Efficacy of treatment when diode laser is used alone as a treatment option after scaling and root planing.'}, {'measure': 'use of desensitising agent alone', 'timeFrame': '30 minutes', 'description': 'Efficacy of treatment when desensitising agent was used as monotherapy after scaling and root planing'}, {'measure': 'combination of densensitising agent and diode laser', 'timeFrame': '30 minutes', 'description': '3\\. Efficacy of treatment when a combination of diode laser and desensitising agent was used after scaling and root planing, for the treatment of dentinal hypersensitivity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fluorosis, Dental', 'Non-Fluoride Enamel Opacities', 'Dentin Sensitivity']}, 'descriptionModule': {'briefSummary': 'The present study was designed as a randomised controlled clinical trial which was unicenter, double-blinded, parallel designed study, according to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010. The study period was from July 2014 to September 2015.', 'detailedDescription': "90 Patients visiting the Out Patient of Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, India, presenting with a chief complaint of dentinal hypersensitivity were enrolled in the study. Patients' age ranged from 18-60 years. The subjects interested in participating were explained in detail the treatment protocol. A verbal consent as well as a written informed consent was obtained from each patient Treatment of dentinal hypersensitivity with a combination of diode laser and potassium nitrate desensitising agent was considered as the test group and this was compared with diode lasers alone and desensitising agent alone as the positive control groups. The study was conducted in full accordance with the declared ethical principles (World Medical Association Declaration of Helsinki, version VII, 2013)13 and was approved by the Institutional review board of Krishnadevaraya College of Dental Science and Hospital, under the registration number of (ACA/DCD/SYN/KCODS - B/PG/2013-2014)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients with a positive response for hypersensitivity testing (Pashley, 1990) i.e. cold water testing using ice cold water (Trowbridge et al., 1980),\n\n * Air blow test (Coleman and Kinderknecht, 2000),\n * Electric tactile stimulation test (Camps and Pashley, 2003),\n * Patients presenting with non-carious cervical lesions in the enamel (Loomba et al., 2013), fluorosed teeth wherein fluorotic enamel staining confirmed by clinical examination, healthy non fluorosed teeth, which was confirmed by clinical examination (Dean, 1934).\n\nExclusion Criteria:\n\n* The following were set as the exclusion criteria;\n\n * Patients undergoing any form of restorative endodontic,\n * Orthodontic treatment or crown restorations,\n * Local defects including caries and fractures,\n * Presence of any systemic diseases,\n * Acute pain conditions (like apical periodontitis, periapical abscess),\n * Presence of periodontal disease or a history of periodontal treatment in last 6 months,\n * Usage of desensitising toothpaste or mouth rinse in the last 4 weeks,\n * Patients allergic to ingredients used in the study product,\n * Teeth with intrinsic stains caused by other reasons.'}, 'identificationModule': {'nctId': 'NCT03237793', 'briefTitle': 'Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Krishnadevaraya College of Dental Sciences & Hospital'}, 'officialTitle': 'Treatment of Hypersensitivity Using Diode Laser and Potassium Nitrate Desensitising Agent- a Comparison of Treatment Effects on Fluorosed and Non-fluorosed Teeth- an in Vivo Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '02_D012_45912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fluorosed Group', 'description': '45 patients for the fluorosis groupGROUP 1A: Patients with healthy fluorosed teeth receiving desensitising agent (potassium nitrate- RA Themoseal\\*\\*) treatment. (n=15) GROUP 1B: Patients with healthy fluorosed teeth receiving diode laser treatment$. (n=15) GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA Thermoseal\\*\\*) treatment. (n=15)', 'interventionNames': ['Procedure: Fluorosed Group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non Flourosed Group', 'description': '45 patients for the non-fluorosis groupGROUP 2- Non Flourosed Group (n=45) GROUP 2A: Patients with healthy non fluorosed teeth receiving desensitising agent (potassium nitrate- RA Thermoseal\\*\\*) treatment. (n=15) GROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal\\*\\*) treatment. (n=15', 'interventionNames': ['Procedure: Non Flourosed Group']}], 'interventions': [{'name': 'Fluorosed Group', 'type': 'PROCEDURE', 'description': 'A single episode of laser therapy with without potassium nitrate (RA Thermoseal\\*) desensitising agent application was administered to the patients, A group only with desensitising paste and A group with desensitising paste and laser treatment depending on the study group they were assigned', 'armGroupLabels': ['Fluorosed Group']}, {'name': 'Non Flourosed Group', 'type': 'PROCEDURE', 'description': 'A single episode of laser† therapy with or without potassium nitrate (RA Thermoseal\\*) desensitising agent application was administered to the patients, depending on the study group they were assignedGROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal\\*\\*) treatment.', 'armGroupLabels': ['Non Flourosed Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rashmi Paramashivaiah, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krishnadevaraya college of dental sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krishnadevaraya College of Dental Sciences & Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}