Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-30 @ 6:07 PM
Study NCT ID:
NCT05608057
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gingival pigmentation score', 'timeFrame': 'baseline, 1 month, 2 months', 'description': 'Score 0: Absence of pigmentation Score 1: Spots of brown to black color or pigments. Score 2: Brown to black patches but not diffuse pigmentation Score 3: Diffuse brown to black pigmentation, marginal, and attached gingiva'}], 'secondaryOutcomes': [{'measure': 'Change in pain score', 'timeFrame': 'up to 1 week', 'description': 'Visual Analogue Scale (VAS) is a simple measurement tool that measures the intensity of pain as recorded by the patient. 10 point visual analog scale of pain rating, the left side is marked "no pain" and the right side marked "worst pain imaginable.'}, {'measure': 'Patient satisfaction', 'timeFrame': 'after 2 months', 'description': 'After 2 months, patients will be asked to answer three questions to evaluate the level of satisfaction with each technique:\n\nDid you notice a cosmetic change 2 months after the treatment? (1) No, (2) Moderate, (3) Marked Did treatment meet your expectation? (1) No, (2) yes, (3) Over and above Would you repeat treatment if necessary? (1) No, (2) yes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Pigmentation']}, 'referencesModule': {'references': [{'pmid': '37990224', 'type': 'DERIVED', 'citation': 'Esmat SA, El-Sayed NM, Fahmy RA. Vitamin C mesotherapy versus diode laser for the esthetic management of physiologic gingival hyperpigmentation: a randomized clinical trial. BMC Oral Health. 2023 Nov 21;23(1):899. doi: 10.1186/s12903-023-03614-7.'}]}, 'descriptionModule': {'briefSummary': 'Physiologic pigmentation affects the gingival esthetics. Laser ablation has been recently used as the most effective and reliable technique for gingival depigmentation. However, the high cost of laser technology limits its use in dental practice. Vitamin C/Ascorbic acid mesotherapy has been proposed as a minimally invasive, safe, cost-effective new modality of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 18 and 45 years old with physiologic melanin pigmentation in the anterior esthetic portion of the maxillary or mandibular gingiva.\n* Systemically free\n\nExclusion Criteria:\n\n* Smokers.\n* Drugs intake, which associates with gingival melanin pigmentation.\n* Pregnant and lactating women.\n* Patients with known hypersensitivity to ascorbic acid.\n* Patients with bad oral hygiene.\n* Pigmentation of the gingiva due to heavy metal ingestion'}, 'identificationModule': {'nctId': 'NCT05608057', 'briefTitle': 'Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation (Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': 'Laser_VitC2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C mesotherapy', 'interventionNames': ['Other: Vitamin C mesotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diode laser', 'interventionNames': ['Radiation: Diode laser']}], 'interventions': [{'name': 'Vitamin C mesotherapy', 'type': 'OTHER', 'description': 'Vitamin C intra-mucosal injection; in which the site of interest will be anesthetized using a topical anesthetic agent (lidocaine gel or xylocaine gel) or infiltration anesthesia, followed by intra-mucosal field injections of 1-1.5 ml Cevarol (L-Ascorbic acid 1000 mg/5 ml', 'armGroupLabels': ['Vitamin C mesotherapy']}, {'name': 'Diode laser', 'type': 'RADIATION', 'description': 'Diode laser ablation: in which the site of interest will be anesthetized using infiltration anesthesia, followed by laser ablation. 980nm Diode laser will be applied using the following setting parameters: continuous mode with 980nm wavelength at 1.5 W output power.', 'armGroupLabels': ['Diode laser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Sara Esmat, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University, Faculty of Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}