Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT06923904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D054023', 'term': 'Lasers, Semiconductor'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This will be a randomized clinical trial (RCT) with a split-mouth design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of dentin hypersensitivity', 'timeFrame': 'From enrollment to 6 months after desensitizing procedure', 'description': 'assessed using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The DHEQ is a validated self-report tool designed to assess the impact of dentine hy-persensitivity on a patient\'s daily life, including the intensity and frequency of symptoms as well as the emotional, social, and practical effects on daily activities such as eating, drinking, and oral hygiene practices. The DHEQ consists of 15 questions, with responses rated on a numerical scale from 1 ("strongly disagree") to 7 ("strongly agree"). The final score is calculated out of a total of 105 points, with higher scores indicating a greater im-pact of dentin sensitivity on daily life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['desensitizing treatment', 'diode laser', 'oral hygiene', 'dental sensitivity'], 'conditions': ['Dentistry', 'Desensitization']}, 'descriptionModule': {'briefSummary': 'Our aim will be to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser. Dental hypersensitivity (DH) will be assessed pre- (T0) and post-treatment (T1) and at 1 month (T2), 3 months (T3), and 6 months (T4).', 'detailedDescription': 'This will be a randomized clinical trial (RCT) with a split-mouth design, involving 12 subjects, with two parallel groups. The dental elements will be divided into the Trial group, treated with a 980 nm diode laser and desensitizing topical gel, and the Control group, treated only with the same gel. DH will be assessed using the Shiff Air Index (SAI) and Visual Analog Scale (VAS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The inclusion criteria will be as follows: (a) a good standard of home oral hygiene and (b) at least two teeth affected by DH.\n\nThe exclusion criteria will be: (a) individuals taking pain relievers; (b) individuals undergoing orthodontic treatment; (c) non-vital teeth; (d) teeth with restorative materials; and (e) pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT06923904', 'acronym': 'PotassiumNitra', 'briefTitle': 'Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity', 'orgStudyIdInfo': {'id': 'PotassiumNitrateLaser'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with dental sensitivity', 'description': 'With a split-mouth design the dental elements will be divided into the Trial group, treated with a 980 nm diode laser and desensitizing topical gel, and the Control group, treated only with the same gel.', 'interventionNames': ['Other: Trial group, treated with a 980 nm diode laser and desensitizing topical gel']}], 'interventions': [{'name': 'Trial group, treated with a 980 nm diode laser and desensitizing topical gel', 'type': 'OTHER', 'description': 'The study aims to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser.', 'armGroupLabels': ['Patients with dental sensitivity']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrea Scribante, DDS PhD MHA MSc', 'role': 'CONTACT', 'email': 'andrea.scribante@unipv.it', 'phone': '+39382516209'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be publish as aggregate data with descriptive and inferential statistics'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrea Scribante', 'investigatorAffiliation': 'University of Pavia'}}}}