Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:42 AM
Study NCT ID:
NCT07449169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diode Laser Plus CPP-ACPF vs CPP-ACPF Alone for Dentin Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor and analyst will be blinded to the intervention group assigned to the patients.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in dentin hypersensitivity in response to evaporative (air-blast) stimulus', 'timeFrame': 'Assessed at baseline, immediately post-treatment, and at 1 month, 3 months, and 6 months follow-up.', 'description': 'Change in dentin hypersensitivity in response to an evaporative (air-blast) stimulus, measured using a visual analog scale (VAS). Lower scores indicate reduced sensitivity.\n\nScores: 0-10 (Ordinal) where 0 represents "no pain" and 10 represents "greatest pain".'}], 'secondaryOutcomes': [{'measure': 'Reduction in dentin hypersensitivity in response to tactile (dental probe) stimulus.', 'timeFrame': 'Assessed at baseline, immediately post-treatment, and at 1 month, 3 months, and 6 months follow-up.', 'description': 'Change in dentin hypersensitivity in response to a tactile stimulus using a dental probe, measured with a visual analog scale (VAS). Lower scores indicate reduced sensitivity.\n\nScores: 0-10 (Ordinal) where 0 represents "no pain" and 10 represents "greatest pain".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dentin hypersensitivity', 'tooth hypersensitivity', 'diode laser', 'CPP-ACPF varnish', 'Dental laser treatment', 'Non-carious cervical lesions', 'Desensitizing treatment', 'photobiomodulation'], 'conditions': ['Dentin Hypersensitivity', 'Tooth Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of diode laser photobiomodulation combined with CPP-ACPF varnish versus CPP-ACPF varnish alone in reducing dentin hypersensitivity. Participants diagnosed with dentin hypersensitivity will receive either the combined treatment or varnish application alone. Pain levels will be evaluated using a standardized visual analog scale before and after treatment sessions. The results of this study may help determine whether adding diode laser therapy enhances the effectiveness of conventional varnish treatment in managing dentin hypersensitivity.', 'detailedDescription': 'This study is a clinical trial designed to evaluate the effectiveness of two treatments for dentin hypersensitivity, which is the pain or discomfort felt when teeth are exposed to hot, cold, sweet, or touch.\n\nParticipants who meet the study criteria will be randomly assigned to one of two groups:\n\nGroup A: Treatment with a diode laser combined with CPP-ACPF varnish applied to the sensitive teeth.\n\nGroup B: Treatment with CPP-ACPF varnish alone.\n\nStudy Procedures:\n\nScreening and Enrollment: Participants will undergo a dental examination to confirm they have sensitive teeth. Medical history and consent will be collected.\n\nBaseline Assessment: Pain sensitivity will be measured using a simple pain scale to record how severe the sensitivity is before treatment.\n\nTreatment: The assigned treatment will be applied to the sensitive teeth. The laser procedure is painless and safe, and the varnish is a commonly used dental material.\n\nFollow-Up Visits: Participants will return for follow-up assessments immediately after treatment, after one month, after three months, and after six months. Pain sensitivity will be measured at each visit to track changes over time.\n\nSafety and Monitoring:\n\nThe procedures are safe, and side effects are expected to be minimal.\n\nAny discomfort or unexpected reactions will be addressed promptly by the dental team.\n\nParticipants can withdraw from the study at any time without affecting their standard dental care.\n\nPurpose of the Study:\n\nThe goal is to determine whether combining diode laser treatment with CPP-ACPF varnish is more effective at reducing tooth sensitivity than using the varnish alone. The results may help dentists provide the best treatment options for patients with sensitive teeth in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants aged from 20 to 50 years of age.\n* Participants with good oral hygiene.\n* Presence of at least one tooth with dentin hypersensitivity confirmed by the air blast and/or tactile stimuli (scoring ≥3 on the VAS).\n* Participants willing to cooperate and attend recall appointments\n* Teeth with Non-Carious Cervical Lesions.\n* Patients with dentin hypersensitivity due to GERD and Parafunctional habits e.g., bruxism.\n* Patients with dentin hypersensitivity associated with gingival recession.\n\nExclusion Criteria:\n\n* Participants with poor oral hygiene.\n* History of professional or at-home desensitizing treatment within the previous 3 months.\n* Pregnant or lactating females.\n* Concurrent participation in other research studies.\n* Inability to comply with study procedures.\n* History of allergic reactions to study materials.\n* Medical conditions interfering with pain reporting accuracy (pain disorders, constant use of analgesics, anti-inflammatory, or psychotropic medications).\n* History of periodontal surgeries within the last six months.\n* Periodontitis and pulpitis.'}, 'identificationModule': {'nctId': 'NCT07449169', 'briefTitle': 'Diode Laser Plus CPP-ACPF vs CPP-ACPF Alone for Dentin Hypersensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Efficacy of Diode Laser Photobiomodulation Combined With CPP-ACPF Varnish Versus CPP-ACPF Varnish Alone in the Management of Dentin Hypersensitivity: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Cons-DH-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A - Diode Laser + CPP-ACPF', 'description': 'Participants will receive diode laser treatment combined with CPP-ACPF varnish on sensitive teeth.', 'interventionNames': ['Device: Diode laser photobiomodulation combined with CPP-ACPF varnish']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B - CPP-ACPF Varnish Alone', 'description': 'Participants will receive CPP-ACPF varnish alone on sensitive teeth.', 'interventionNames': ['Other: CPP-ACPF varnish']}], 'interventions': [{'name': 'Diode laser photobiomodulation combined with CPP-ACPF varnish', 'type': 'DEVICE', 'otherNames': ['Diode laser therapy', 'Low-level laser therapy (LLLT)', 'photobiomodulation', 'PBM'], 'description': "Participants will receive diode laser photobiomodulation applied to sensitive teeth followed by application of CPP-ACPF varnish according to the manufacturer's instructions. This combination treatment is intended to reduce dentin hypersensitivity.", 'armGroupLabels': ['Group A - Diode Laser + CPP-ACPF']}, {'name': 'CPP-ACPF varnish', 'type': 'OTHER', 'otherNames': ['Casein phosphopeptide-amorphous calcium phosphate fluoride varnish'], 'description': "Participants will receive CPP-ACPF varnish applied to sensitive teeth according to the manufacturer's instructions to reduce dentin hypersensitivity.", 'armGroupLabels': ['Group B - CPP-ACPF Varnish Alone']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': "Mariam M Mohamed, Master's candidate", 'role': 'CONTACT', 'email': 'mariam.kamal@dentistry.cu.edu.eg', 'phone': '+20 100 088 2942'}, {'name': 'Mona M Eissa', 'role': 'CONTACT', 'email': 'monamahmoud@dentistry.cu.edu.eg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dentist', 'investigatorFullName': 'Mariam Mamdouh Mohamed Kamal', 'investigatorAffiliation': 'Cairo University'}}}}