Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT06720168
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003777', 'term': 'Dental Prophylaxis'}], 'ancestors': [{'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of dental black stain', 'timeFrame': '3, 6, 9 and 12 months', 'description': 'Following dental prophylaxis (in each of the arms) the dentist will assess the recurrence of black stains at 3, 6, 9 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'Immediately after the intervention', 'description': 'Patients will received, at the end of the procedure a questionnaire to evaluate their satisfaction with the care provided, evaluating from 0 to 5 the level of disconfort experienced during the treatment (0 no disconfort, 5 maximum disconfort).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental black stain', 'dental prophylaxis', 'erythritol air polisher'], 'conditions': ['Black Stain', 'Black Plaque']}, 'descriptionModule': {'briefSummary': "Black stains on the teeth, caused by the accumulation of chromogenic microorganisms that produce iron compounds, are more common in the pediatric population and have a negative impact on dental aesthetics and patients' self-esteem. The etiology of these stains remains unclear and is not related to oral hygiene. Currently, there is no definitive treatment that prevents the reappearance of these stains, and they can only be removed by mechanical removal, which can cause injuries to the tooth structure. This study aims to evaluate the effectiveness of erythritol powder air polishers, which have antimicrobial properties, compared to conventional prophylaxis in preventing the recurrence of stains.\n\nA randomized clinical trial will be carried out with a follow-up of 12 months, during which patient satisfaction and duration of treatment will be assessed. The results of this study could provide valuable information to improve treatment and management strategies for dental stains in the affected population, thus contributing to the emotional well-being of patients and reducing damage to their tooth enamel."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with 2 or more teeth with black stain\n\nExclusion Criteria:\n\n* Sistemic diseases\n* Patients with physical and/or cognitive impairment which prevents participation in a dental prophylaxis.\n* Use of oral antibiotics fifteen days before the intervention\n* Allergy to erythritol'}, 'identificationModule': {'nctId': 'NCT06720168', 'briefTitle': 'Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin', 'orgStudyIdInfo': {'id': 'UCHCEU Jovani-Ribelles-Veses'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dental prophylaxis with ultrasonic treatment', 'description': 'Dental Prophylaxis with ultrasonics', 'interventionNames': ['Device: Dental prophylaxis with ultrasonic treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Dental prophylaxis with erythritol air polishing', 'description': 'Dental prophylaxis with erythritol air polishing application', 'interventionNames': ['Device: Erythritol air polisher']}], 'interventions': [{'name': 'Erythritol air polisher', 'type': 'DEVICE', 'description': 'Dental prophylaxis with erythritol air polisher in patients with dental black stain', 'armGroupLabels': ['Dental prophylaxis with erythritol air polishing']}, {'name': 'Dental prophylaxis with ultrasonic treatment', 'type': 'DEVICE', 'description': 'Dental prophylaxis with ultrasonic treatment in patients with dental black stain', 'armGroupLabels': ['Dental prophylaxis with ultrasonic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46115', 'city': 'Alfara del Patriarca', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Universidad CEU Cardenal Herrera', 'geoPoint': {'lat': 39.55, 'lon': -0.38333}}], 'centralContacts': [{'name': 'María del Mar Jovani-Sancho, DDS, PhD', 'role': 'CONTACT', 'email': 'marjovani@uchceu.es', 'phone': '+34961369000', 'phoneExt': '64302'}, {'name': 'Veronica Veses, BSc (Hon), PhD', 'role': 'CONTACT', 'email': 'veronica.veses@uchceu.es', 'phone': '+34961369000', 'phoneExt': '64524'}], 'overallOfficials': [{'name': 'María del Mar Jovani-Sancho, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardenal Herrera University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Tenured Professor', 'investigatorFullName': 'Chirag Sheth', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}