Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT06746558
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2024-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Dentinal Hypersensitivity (Shiff Air Index)', 'timeFrame': 'Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4)', 'description': 'The Shiff Air Index measures sensitivity by applying a standardized air stimulus to the dental surface. Patients report their sensitivity level on a scale from 0 to 3, where 0 indicates no sensitivity and 3 indicates severe sensitivity. The scores are interpreted to assess the degree of dentinal hypersensitivity.'}, {'measure': 'Reduction in Dentinal Hypersensitivity (Visual Analog Scale)', 'timeFrame': 'Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4).', 'description': 'The Visual Analog Scale (VAS) measures the intensity of pain by asking participants to rate their pain on a 10-point scale, where 0 represents no pain and 10 represents the worst pain imaginable. Participants will receive guidance to mark their pain level on the scale based on their subjective experience, providing a standardized measure of dentinal hypersensitivity.'}], 'secondaryOutcomes': [{'measure': 'Changes in Quality of Life (Dentine Hypersensitivity Experience Questionnaire)', 'timeFrame': 'Baseline (T0) and 6 months (T4)', 'description': 'The Dentine Hypersensitivity Experience Questionnaire (DHEQ) is a validated tool designed to assess the impact of dentinal hypersensitivity on daily activities, emotions, and overall quality of life. It consists of 15 questions rated on a 1 to 7 scale, where higher scores indicate a greater negative impact on quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dentinal hypersensitivity', 'potassium nitrate', 'diode laser therapy', 'desensitization', 'dental pain management'], 'conditions': ['Hypersensitivity Dentin']}, 'referencesModule': {'references': [{'pmid': '33841742', 'type': 'BACKGROUND', 'citation': 'Simoes TM, Melo KC, Fernandes-Neto JA, Batista AL, da Silva MG, Ferreira AC, de Sousa JA, Catao MV. Use of high- and low-intensity lasers in the treatment of dentin hypersensitivity: A literature review. J Clin Exp Dent. 2021 Apr 1;13(4):e412-e417. doi: 10.4317/jced.57783. eCollection 2021 Apr.'}], 'seeAlsoLinks': [{'url': 'https://portale.unipv.it/it', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized clinical trial is to evaluate whether combining a potassium nitrate gel with diode laser therapy is more effective in treating dentinal hypersensitivity compared to using the gel alone. The study involves adult participants with at least two teeth affected by dentinal hypersensitivity. The main questions it aims to answer are:\n\nDoes the combined use of potassium nitrate gel and diode laser therapy reduce dentinal hypersensitivity more effectively than gel alone? How does this combined treatment impact sensitivity-related quality of life over time? Researchers will compare the outcomes between the two groups (combined therapy versus gel alone) to determine the effectiveness of the combined treatment.\n\nParticipants will:\n\nUndergo assessments of dentinal hypersensitivity using the Shiff Air Index (SAI) and Visual Analog Scale (VAS) at baseline and at follow-ups (1 month, 3 months, and 6 months post-treatment).\n\nComplete a questionnaire to evaluate the impact of dentinal hypersensitivity on daily life at baseline and after 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* At least two teeth affected by dentinal hypersensitivity.\n* Good standard of home oral hygiene.\n\nExclusion Criteria:\n\n* Use of pain relievers.\n* Ongoing orthodontic treatment.\n* Non-vital teeth or teeth with restorative materials.\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT06746558', 'briefTitle': 'Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Clinical Evaluation of the Combined Effect of a Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '76 2022-0316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Potassium Nitrate Gel with Diode Laser Therapy', 'interventionNames': ['Combination Product: Potassium Nitrate Gel and Diode Laser Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Potassium Nitrate Gel Alone', 'interventionNames': ['Drug: Potassium Nitrate Gel Alone']}], 'interventions': [{'name': 'Potassium Nitrate Gel and Diode Laser Therapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants in the experimental group receive treatment combining a desensitizing gel containing 5% potassium nitrate (Emoform Actisens) applied to affected teeth and diode laser therapy (980 nm). The laser is used with specific power settings (0.3W, 0.5W, 0.7W) for 20 seconds at each setting, followed by a second application of the gel and irradiation. The treatment aims to reduce dentinal hypersensitivity by occluding dentinal tubules and altering neural responses.', 'armGroupLabels': ['Potassium Nitrate Gel with Diode Laser Therapy']}, {'name': 'Potassium Nitrate Gel Alone', 'type': 'DRUG', 'description': 'Participants in the control group receive treatment with a desensitizing gel containing 5% potassium nitrate (Emoform Actisens) applied to the teeth. The gel is applied twice using a microbrush in a rubbing motion for 2 minutes each time. No diode laser therapy is administered. This intervention aims to evaluate the standalone efficacy of the gel in reducing dentinal hypersensitivity.', 'armGroupLabels': ['Potassium Nitrate Gel Alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pavia', 'state': 'PV', 'country': 'Italy', 'facility': 'Università degli Studi di Pavia, Department of Orthodontics', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pavia', 'class': 'OTHER'}, {'name': 'University of Genova', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, Orthod Spec, PhD, Research Fellow', 'investigatorFullName': 'Alessandro Bruni', 'investigatorAffiliation': 'University of Modena and Reggio Emilia'}}}}