Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:20 AM
Study NCT ID:
NCT07426432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2025-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2025-12-20', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'White Spot Lesions', 'timeFrame': 'six months', 'description': 'Incidence and Severity of White Spot Lesions Measured at baseline, third (T1) and sixth (T2) months, by Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).'}], 'secondaryOutcomes': [{'measure': 'Periodontal Ligament (PDL) Health', 'timeFrame': 'six months', 'description': 'Periodontal Ligament (PDL) Health using:\n\n* Pocket Depth Index (PDI), by periodontal probe\n\n 1. 1-3 mm: Healthy or mild inflammation.\n 2. 4-5 mm: Moderate periodontal disease.\n 3. ≥6 mm: Severe periodontal disease with potential bone loss.'}, {'measure': 'Gingival Bleeding and Inflammation', 'timeFrame': 'six months', 'description': 'Gingival Bleeding Index (GBI) Dichotomous (yes/no bleeding) no=0 yes=1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['White Spot Lesions', 'Clear Aligner Appliance']}, 'descriptionModule': {'briefSummary': 'Aim of this study: evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions.\n\nMaterial and methods:\n\nType: Prospective, randomized split mouth controlled study.\n\nInterventions:\n\nIntervention Group (Experimental Side):\n\n•Application of fluoride-releasing composite\n\nControl Group (Control Side):\n\n•Application of conventional composite\n\nOutcome Measures:\n\nPrimary Outcome: Incidence and Severity of White Spot Lesions\n\nSecondary Outcomes:\n\n1. Periodontal Ligament (PDL) Health\n2. Gingival Bleeding and Inflammation', 'detailedDescription': 'Aim of the Study:\n\nThe aim of this study is to evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions (WSLs) development during clear aligner therapy in comparison to a split-mouth controlled group.\n\nMaterial and methods:\n\nStudy Design:\n\nEach participant will have one side of the mouth assigned to fluoride-releasing composite intervention as attachments, while the contralateral side will be assigned to conventional composite as attachments.\n\nSample size calculation:\n\nSample size calculation was based on effect of fluoride-releasing composite resin on prevention of White Spot Lesions during Clear Aligner Therapy: that was retrieved from most similar research Abdullah et al. Using G power program version 3.1.9.7 to calculate sample size based on effect size of 1.08 that is based on mean area of white spots, using 2-tailed test, α error = 0.05 and power = 95% , the total calculated sample size will be 24 in each group. To mitigate the potential impact of an anticipated 20% dropout rate, the recruitment target was increased to 30 patients per treatment group, aiming to ensure adequate statistical power in the final analyzed sample.\n\nInclusion Criteria:\n\n* Patients aged 16-24 years.\n* Good general and oral health.\n* Mild dental crowding per arch (≤ 4 mm).\n\nExclusion Criteria:\n\n* Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).\n* Patients with Cleft lip and palate.\n* Previous orthodontic treatment.\n* Dental fluorosis.\n* Hypocalcified teeth or visible demineralization.\n\nInterventions:\n\n1. Initial Oral Scan:\n\n A 3D oral scan of the arch to be treated will be performed using a digital intraoral scanner\n2. Aligner Fabrication:\n\n Aligners will be fabricated using thermoforming techniques. Intervention Group (Experimental Side): application of a fluoride-releasing composite on the indicated side of the mouth as attachments.\n\n Control Group (Control Side): application of conventional composite as attachments.\n3. Aligner Placement: the aligners will be fitted, and patients will wear them continuously, except during eating and brushing.\n\nOutcome Measures:\n\nPrimary Outcome: Incidence and Severity of White Spot Lesions Measured at base line, third (T1) and sixth (T2) months.\n\n1.Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).\n\nSecondary Outcome:\n\n1. Periodontal Ligament (PDL) Health using: Pocket Depth Index (PDI)\n2. Gingival Bleeding and Inflammation\n\nDuration of the study:\n\n•This study is suggested to be finished in 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 16-24 years.\n* Good general and oral health.\n* Mild dental crowding per arch (≤ 4 mm).\n\nExclusion Criteria:\n\n* Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).\n* Patients with Cleft lip and palate.\n* Previous orthodontic treatment.\n* Dental fluorosis.\n* Hypocalcified teeth or visible demineralization.'}, 'identificationModule': {'nctId': 'NCT07426432', 'briefTitle': 'Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy: A Controlled Split-Mouth Study', 'orgStudyIdInfo': {'id': 'Mansoura_ University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group (Experimental Side)', 'description': 'application of fluoride-releasing composite on the indicated side of the mouth as attachments.', 'interventionNames': ['Other: Application of fluoride-releasing composite']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (Control Side)', 'description': 'application of conventional composite as attachments.', 'interventionNames': ['Other: Application of conventional composite']}], 'interventions': [{'name': 'Application of fluoride-releasing composite', 'type': 'OTHER', 'description': 'using fluoride releasing composite for attachment construction', 'armGroupLabels': ['Intervention Group (Experimental Side)']}, {'name': 'Application of conventional composite', 'type': 'OTHER', 'description': 'using non fluoridated composite for attachment construction', 'armGroupLabels': ['Control Group (Control Side)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dentist Mohammed Amer', 'investigatorFullName': 'Mohammed Amer', 'investigatorAffiliation': 'Mansoura University'}}}}