Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-31 @ 1:32 PM
Study NCT ID:
NCT07229105
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of Remineralization Agents on Attachment-Associated Demineralization in Clear Aligner Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C094502', 'term': 'Bifluorid 12'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Enamel Demineralization (DIAGNOdent values).', 'timeFrame': 'Baseline (T0) to 6 months (T3).', 'description': 'Measurements taken using DIAGNOdent pen around attachment margins. Validated cut-off values: 0-12 sound, 13-24 initial, \\>25 advanced.'}], 'secondaryOutcomes': [{'measure': 'Temporal Changes in Enamel Mineralization', 'timeFrame': '1 month (T1) and 3 months (T2)', 'description': 'Evaluation of DIAGNOdent values at intermediate time points to assess the progression or regression patterns (e.g., continuous improvement vs. biphasic response) of demineralization.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clear aligners', 'Orthodontic Attachments', 'DIAGNOdent', 'White Spot Lesions', 'White Spot Lesion'], 'conditions': ['White Spot Lesions', 'Demineralization', 'Dental Caries', 'Orthodontic Treatment']}, 'descriptionModule': {'briefSummary': 'Background/ Objectives: Clear aligner attachments increase the risk of white spot lesions (WSL), with a 35.5% incidence in adolescents. The number of anterior attachments is an independent risk factor (OR=2.192). Despite 17 million patients treated worldwide, no study has quantitatively assessed demineralization around attachment margins. To compare the effectiveness of CPP-ACP, nano-hydroxyapatite (nHAp), and fluoride varnish versus a control for attachment-associated demineralization using DIAGNOdent monitoring.\n\nMethods: This prospective observational study evaluated 52 patients; 45 were enrolled, and 40 completed after five pre-baseline withdrawals. Participants were allocated to four groups (n=10 each): Group A (control, fluoride toothpaste), Group B (CPP-ACP daily), Group C (nHAp professional + home gel), and Group D (fluoride varnish quarterly). DIAGNOdent measurements were taken around attachments at baseline, 1, 3, and 6 months. Linear mixed-effects models analyzed group differences (p\\<0.05).', 'detailedDescription': "DIAGNOdent Measurement Protocol Calibration and Standardization The DIAGNOdent pen (KaVo, Biberach, Germany) was calibrated before each measurement session according to the manufacturer's instructions using a ceramic standard\\[18\\]. A single calibrated examiner performed all measurements to ensure consistency. Intra-examiner reliability was assessed using intraclass correlation coefficient (ICC) with two-way mixed model, absolute agreement, calculated from 30 repeated measurements at 10 randomly selected attachment sites (ICC = 0.85, 95% CI: 0.79-0.91).\n\nMeasurement Technique A standardized measurement protocol was employed for all DIAGNOdent assessments. Teeth were air-dried for 5 seconds prior to measurement, and the probe tip was positioned perpendicular to the enamel surface to ensure consistent readings. Four measurements were obtained per attachment site at the mesial, distal, gingival, and occlusal margins. Three measurement passes were performed at each site, with the maximum value recorded to represent the most advanced demineralization present. Measurements were conducted at four timepoints: baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 16-45 years\n* Active clear aligner treatment with minimum 6 months remaining\n* Presence of ≥10 attachments on anterior teeth and premolars\n* Good general health\n* Commitment to prescribed aligner wear (20-22 hours/day)\n\nExclusion Criteria:\n\n* Active carious lesions\n* Periodontal disease\n* Fluorosis or enamel hypoplasia\n* Current fluoride supplement use beyond standard toothpaste\n* Pregnancy or lactation\n* Systemic conditions affecting salivary flow'}, 'identificationModule': {'nctId': 'NCT07229105', 'briefTitle': 'Comparative Effectiveness of Remineralization Agents on Attachment-Associated Demineralization in Clear Aligner Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Comparative Effectiveness of Remineralization Agents on Attachment-Associated Demineralization in Clear Aligner Patients: A 6-Month DIAGNOdent-Based Observational Study', 'orgStudyIdInfo': {'id': '09/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A: Control', 'description': 'The participants used standard fluoride toothpaste (1450 ppm) twice daily, with no additional remineralization protocol.'}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Casein Phosphopeptide-Amorphous Calcium Phosphate', 'description': 'In addition to standard fluoride toothpaste, participants applied GC Tooth Mousse (CPP-ACP) to their clear aligners once daily for 15 minutes before bedtime.', 'interventionNames': ['Device: GC Tooth Mousse']}, {'type': 'EXPERIMENTAL', 'label': 'Group C: Nano-Hydroxyapatite', 'description': 'Professional in-office application of 5% nHAp gel at baseline, 1, and 3 months, combined with daily home application of 1% nHAp gel into aligners.', 'interventionNames': ['Device: Nano-Hydroxyapatite Gel']}, {'type': 'EXPERIMENTAL', 'label': 'Group D: Professional Fluoride Varnish', 'description': 'Professional application of 5% sodium fluoride varnish (ProShield) applied to attachment margins at baseline and 3 months.', 'interventionNames': ['Drug: Sodium Fluoride varnish']}], 'interventions': [{'name': 'GC Tooth Mousse', 'type': 'DEVICE', 'otherNames': ['CPP-ACP Paste'], 'description': 'Participants applied a pea-sized amount of GC Tooth Mousse into each aligner once daily before bedtime. They wore the aligners with the mousse for 15 minutes and were instructed not to rinse for 30 minutes post-application.', 'armGroupLabels': ['Group B: Casein Phosphopeptide-Amorphous Calcium Phosphate']}, {'name': 'Nano-Hydroxyapatite Gel', 'type': 'DEVICE', 'otherNames': ['BioWhiten ProOffice and Nanocare'], 'description': 'A combined protocol involving: 1) Professional in-office application of 5% nHAp gel (BioWhiten ProOffice) at baseline, 1 month, and 3 months; and 2) Daily home application of 1% nHAp gel (Biowhiten Nanocare) into aligners every night before sleep.', 'armGroupLabels': ['Group C: Nano-Hydroxyapatite']}, {'name': 'Sodium Fluoride varnish', 'type': 'DRUG', 'otherNames': ['ProShield Varnish'], 'description': 'Professional application of 5% sodium fluoride varnish (ProShield) to all tooth surfaces, with special attention to attachment margins, at baseline and 3 months. The varnish was left for 1 minute contact time before removal, with instructions not to eat/drink for 2 hours.', 'armGroupLabels': ['Group D: Professional Fluoride Varnish']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University, Faculty of Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Immediately following publication', 'ipdSharing': 'YES', 'description': 'The datasets generated and analysed during the current study are available from the corresponding author on reasonable request.', 'accessCriteria': 'Researchers can contact the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Banu Kılıç', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}