Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 8:15 PM
Study NCT ID:
NCT05989750
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2023-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Air-polishing With Erythritol During Orthodontic Tretament
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The examiner, the biostatistician and people working in the laboratory for the analyses, will be blinded for allocation group. Only the operator and the participant will be aware of the type of treatment based on the computer-generated allocation table that will be kept at the Trial Master File (TMF) of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, examiner-masked clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearance of white spot lesions (WSL) during orthodontic movement with fixed appliances.', 'timeFrame': '2 years', 'description': 'Number of participants with white spot lesions appearence during the 2-years period of orthodontic treatment'}, {'measure': 'Appearance on inflammatory lesions during orthodontic treatmnet', 'timeFrame': '2 years', 'description': 'Number of participants showing signs of inflammation based on clinical parameters during the 2-year period of orthodontic treatment.'}, {'measure': 'Changes from baseline in clinical parameters', 'timeFrame': '2 years', 'description': 'plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions'}], 'secondaryOutcomes': [{'measure': 'Patient acceptance', 'timeFrame': '2 years', 'description': 'Visual Analogue Scale (VAS) with 0: very satisfied and 10: unsatisfied'}, {'measure': 'Tooth sensitivity', 'timeFrame': '2 years', 'description': 'Visual Analogue Scale (VAS) with 0: no sensitivity and 10: worst senstitivity'}, {'measure': 'Total bacterial counts and counts of 6 periodontal pathogens in subgingival samples from treated pockets', 'timeFrame': '2 years', 'description': 'Changes from baseline of microorganisms will be identified and enumerated by laboratory Real-time Polymerase Chain Reaction'}, {'measure': 'Inflammatory markers in GCF from baseline', 'timeFrame': '2 years', 'description': 'Changes of the Inflammatory markers in the gingival crevicular fluid (GCF) throughout the study will be analyzed by the Bioplex 200 Suspension array system. The concentration of these markers will be expreseed as pg/ml'}, {'measure': 'Toral tretament time', 'timeFrame': '2 years', 'description': 'Treatment time will be recorded at each visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation Gum', 'White Spot Lesion']}, 'descriptionModule': {'briefSummary': 'Patients with multi-bracketed fixed orthodontic treatment are at increased risk of developing white spot lesions (WSL) and gingivitis. Various preventive strategies have been examined to prevent the development of WSLs. During initial non-surgical periodontal therapy, the use of subgingival air-polishing with erythritol powder has shown promising results in reducing deep pockets and gingival inflammation. The efficacy of its use as monotherapy in preventing WSLs and gingival inflammation in patients during orthodontic treatment, has not yet been tested.\n\nThe primary objective of the present study is to compare the effectiveness of an air-polishing device used as monotherapy versus ultrasonic instrumentation (the current gold standard procedure) in preventing white spot lesions (WSL) and gingivitis among young patients undergoing multi-bracketed fixed orthodontic treatment.', 'detailedDescription': 'This is a randomized clinical study for evaluating the performance of an air-polishing device in preventing WSLs and gingivitis among patients undergoing multi-bracketed fixed orthodontic treatment. The null hypothesis tested is that there is no difference between the air-polishing device and the conventional ultrasonic device in preventing WSLs and gingivitis during orthodontic treatment.\n\nClinical examination and clinical samples will be taken before, during and after orthodontic treatment. It is a single center study of 3 years duration involving samples of 60 patients attending the Division of Orthodontics for treatment. Half of the participants will be randomly assigned for treatment with the air-polishing device in every orthodontic appointment, meaning once per month, the other half will be treated with a standard ultrasonic scaler every six months. The study duration for each participant will be approximately 2 years. The investigators will then analyze the prevalence of WSLs using the Quantitative light-induced fluorescence (QLF) method. Gingivitis will be evaluated throughout the study by using standard clinical parameters; the antimicrobial efficacy against several known periodontal pathogens and the host-response (inflammatory markers in GCF) will be measured by the qPCR assay and the multiplex immunoassay, respectively. Clinical evaluation and collection of samples for microbial and host response analysis will be performed every 6 months. Incidence of bracket debonding we will be calculated and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects about to undergo fixed orthodontic treatment will be invited to participate.\n* Age between 12 and 16 years only participants\n* Informed written consent obtained by the parents\n\nExclusion Criteria:\n\n* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject\n* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation\n* Previous enrolment into the current investigation\n* Enrolment of the PI, his/her family members, employees and other dependent persons\n* History of fixed orthodontic treatment\n* Defects on enamel on labial surfaces of the teeth\n* Untreated cavitated lesions\n* Plaque levels \\>25%\n* Periodontitis\n* Multiple missing teeth\n* Cleft lip and/or palate or other craniofacial anomalies or syndromes\n* Patients taking any regular medication\n* Patients with asthmatic problems'}, 'identificationModule': {'nctId': 'NCT05989750', 'acronym': 'AirPort', 'briefTitle': 'Air-polishing With Erythritol During Orthodontic Tretament', 'organization': {'class': 'OTHER', 'fullName': 'University of Geneva, Switzerland'}, 'officialTitle': 'Air-polishing With Erythritol on Prevalence of White Spot Lesions and Gingivitis During Orthodontic Treatment With Fixed Appliances: a Randomized Clinical Trial of 2-years Duration', 'orgStudyIdInfo': {'id': 'BASEC 2023-D0032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control procedure', 'description': 'Ultrasonic scaling and polishing will be performed every 6 months for subgingival cleaning', 'interventionNames': ['Device: Ultrasonic scaler']}, {'type': 'EXPERIMENTAL', 'label': 'Test procedure', 'description': 'AIR-FLOW PROPHYLAXIS MASTER with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning', 'interventionNames': ['Device: Air-Flow Prophylaxis Master']}], 'interventions': [{'name': 'Ultrasonic scaler', 'type': 'DEVICE', 'description': "Ultrasonic scaling for subgingival cleaning every 6 months for 2 years according to the manufacturer's procedures.", 'armGroupLabels': ['Control procedure']}, {'name': 'Air-Flow Prophylaxis Master', 'type': 'DEVICE', 'description': "AIR-FLOW PROPHYLAXIS MASTER with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning according to the manufacturer's procedures.", 'armGroupLabels': ['Test procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Catherine Giannopoulou, Dr med dent', 'role': 'CONTACT', 'email': 'ekaterini.giannopoulou@unige.ch', 'phone': '022 379 40 68'}, {'name': 'Alkisti Zekeridou, Dr med dent', 'role': 'CONTACT', 'email': 'alkisti.zekeridou@unige.ch', 'phone': '022 379 40 30'}], 'facility': 'University of Geneva, University Clinics of Dental Medicine', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catherine Giannopoulou', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Catherine Giannopoulou', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}