Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT06752902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-23
First Post:
2024-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalised Prevention of Microbiological Homeostasis in the Oral Cavity During Fixed Orthodontic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-06-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bacteria in biofilm', 'timeFrame': 'At inclusion', 'description': 'number of pathogenic bacteria measured in the biofilm'}, {'measure': 'bacteria in biofilm', 'timeFrame': 'At 3 months', 'description': 'number of pathogenic bacteria measured in the biofilm'}, {'measure': 'bacteria in biofilm', 'timeFrame': 'At 6 months', 'description': 'number of pathogenic bacteria measured in the biofilm'}, {'measure': 'bacteria in biofilm', 'timeFrame': 'At 9 months', 'description': 'number of pathogenic bacteria measured in the biofilm'}, {'measure': 'bacteria in biofilm', 'timeFrame': 'At 12 months', 'description': 'number of pathogenic bacteria measured in the biofilm'}, {'measure': 'viruses in biofilm', 'timeFrame': 'At inclusion', 'description': 'number of viruses measured in the biofilm'}, {'measure': 'viruses in biofilm', 'timeFrame': 'At 3 months', 'description': 'number of viruses measured in the biofilm'}, {'measure': 'viruses in biofilm', 'timeFrame': 'At 6 months', 'description': 'number of viruses measured in the biofilm'}, {'measure': 'viruses in biofilm', 'timeFrame': 'At 9 months', 'description': 'number of viruses measured in the biofilm'}, {'measure': 'viruses in biofilm', 'timeFrame': 'At 12 months', 'description': 'number of viruses measured in the biofilm'}], 'secondaryOutcomes': [{'measure': "patient's satisfaction", 'timeFrame': 'at 12 months', 'description': 'Patient satisfaction on a numerical scale from 0 to 10.'}, {'measure': 'measurement of immune response', 'timeFrame': 'At inclusion', 'description': 'assay of salivary cytokines in ng/ml'}, {'measure': 'measurement of immune response', 'timeFrame': 'At 3 months', 'description': 'assay of salivary cytokines in ng/ml'}, {'measure': 'measurement of immune response', 'timeFrame': 'At 6 months', 'description': 'assay of salivary cytokines in ng/ml'}, {'measure': 'measurement of immune response', 'timeFrame': 'At 9 months', 'description': 'assay of salivary cytokines in ng/ml'}, {'measure': 'measurement of immune response', 'timeFrame': 'At 12 months', 'description': 'assay of salivary cytokines in ng/ml'}, {'measure': 'plaque index', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'scale QHI: quigley hein index'}, {'measure': 'gingival index,', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'gingival index mesured with Ginigical Index Loe\\&Silness scale'}, {'measure': 'toothbrush wear', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'toothbrush wear with the Toothbrush Wear Index (TWI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral dysbiosis', 'orthodontics', 'oral microbiotis'], 'conditions': ['Orthodontics']}, 'descriptionModule': {'briefSummary': 'Oral dysbiosis systematically develops during orthodontic treatment \\[35\\]\\[36\\]. Orthodontic appliances interfere with oral hygiene procedures and cause biofilm to accumulate, creating new retention zones, even in subjects who maintain correct oral hygiene \\[37\\]:\n\n* A group benefiting from intensive personalised prevention\n* A "conventionally monitored" group, with no personalised prevention. The hypothesis is that personalised prevention prevents dysbiosis from taking hold. If this hypothesis is confirmed, the concept could be extended to all patients, beyond orthodontics.\n\nBased on the "biological signature" (microbiological and immune), a "risk profile" of patients could be defined, making it possible to better personalise the prevention message, the method applied and the frequency of follow-up. The aim would be to rebalance dysbiosis through a personalised prevention approach tailored to the profile defined.\n\nIt was decided to explore this hypothesis initially with orthodontic patients because they are "captive", i.e. in the course of treatment requiring regular visits. Prevention is aimed first and foremost at healthy patients, with the aim of maintaining them in good health. The project focuses on young patients undergoing orthodontic treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment.\n\nExclusion Criteria:\n\n* Tobacco;\n* Overcrowded restorations, untreated caries,\n* lack of tooth mineralisation;\n* Medical pathologies;\n* Known immunodepression (congenital or acquired);\n* Taking a treatment that may induce general immunodepression;\n* Taking a probiotic;\n* Taking a concomitant treatment that may interact with oral health'}, 'identificationModule': {'nctId': 'NCT06752902', 'acronym': 'PREPERMIO', 'briefTitle': 'Personalised Prevention of Microbiological Homeostasis in the Oral Cavity During Fixed Orthodontic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study', 'orgStudyIdInfo': {'id': '23-AOI-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patient with standard care', 'description': 'patient with standard care', 'interventionNames': ['Other: Standard Care Arm']}, {'type': 'OTHER', 'label': 'patient with standard care combined with personalised prevention', 'description': 'patient with standard care combined with personalised prevention', 'interventionNames': ['Other: standard care combined with personalised prevention']}], 'interventions': [{'name': 'Standard Care Arm', 'type': 'OTHER', 'description': 'standard care combined with personalised prevention', 'armGroupLabels': ['patient with standard care']}, {'name': 'standard care combined with personalised prevention', 'type': 'OTHER', 'description': 'standard care combined with personalised prevention', 'armGroupLabels': ['patient with standard care combined with personalised prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Dinan', 'country': 'France', 'contacts': [{'name': 'Olivier Sorel', 'role': 'CONTACT'}, {'name': 'olivier SOREL', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rance Orthodontics Practice', 'geoPoint': {'lat': 48.45553, 'lon': -2.05049}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'Laurence LUPI, PUPH', 'role': 'CONTACT', 'email': 'laurence.lupi@univ-cotedazur.fr', 'phone': '+33492033270'}, {'name': 'laurence LUPI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nice university hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'laurence LUPI, PUPH', 'role': 'CONTACT', 'email': 'laurence.lupi@univ-cotedazur.fr', 'phone': '3392033272'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}