Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-02 @ 12:58 PM
Study NCT ID:
NCT02896556
Status:
COMPLETED
Last Update Posted:
2022-06-03
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017001', 'term': 'Tooth Demineralization'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-09-06', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['image analysis'], 'conditions': ['Tooth Demineralization']}, 'referencesModule': {'references': [{'pmid': '21401750', 'type': 'BACKGROUND', 'citation': 'Kim S, Kim EY, Jeong TS, Kim JW. The evaluation of resin infiltration for masking labial enamel white spot lesions. Int J Paediatr Dent. 2011 Jul;21(4):241-8. doi: 10.1111/j.1365-263X.2011.01126.x. Epub 2011 Mar 14.'}, {'pmid': '23810050', 'type': 'BACKGROUND', 'citation': 'Knosel M, Eckstein A, Helms HJ. Durability of esthetic improvement following Icon resin infiltration of multibracket-induced white spot lesions compared with no therapy over 6 months: a single-center, split-mouth, randomized clinical trial. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):86-96. doi: 10.1016/j.ajodo.2013.02.029.'}, {'pmid': '23989837', 'type': 'BACKGROUND', 'citation': 'Senestraro SV, Crowe JJ, Wang M, Vo A, Huang G, Ferracane J, Covell DA Jr. Minimally invasive resin infiltration of arrested white-spot lesions: a randomized clinical trial. J Am Dent Assoc. 2013 Sep;144(9):997-1005. doi: 10.14219/jada.archive.2013.0225.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the esthetic performance of resin infiltration technique on superficial hypo-mineralized and demineralized enamel lesions of anterior teeth', 'detailedDescription': "The teeth that meet the inclusion criteria will be cleaned from debris and clinical intra-oral photos of the lesions will be taken before and after the treatment. Resin infiltration technique will be performed according to manufacturer's instructions under rubber-dam isolation. Intra-oral photos will be taken directly after infiltration (1 day), and 1 week and 6 months later.\n\nThe system of the Commission Internationale de l'Eclairage (CIE) involving 3 color parameters: lightness (L), red/ green chromaticity (a), and yellow/blue chromaticity (b), will be used to assess the extent and durability of color and lightness changes between lesion and sound enamel areas before and after resin infiltration. The extent of assimilation and durability of effect will be assessed by comparing CIE L\\*a\\*b data collected before infiltration (baseline), directly after infiltration (1 day), and 1 week and 6 months later.\n\nThe color assessments were standardized using a spectrophotometer (SpectroShade, Italy). Lesion areas will be measured for each time point by using an image analysis toolkit (ImageJ, National Institutes of Health, Bethesda, Md.).\n\nMultifactorial analysis of variance with repeated measures will be used for statistical analyses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients and parents of patients who accept to participate and sign the informed consent.\n* At least one non-cavitated anterior teeth with a superficial discoloration on enamel due to demineralization or hypo mineralization\n* Fully erupted anterior teeth with closed apices.\n\nExclusion Criteria:\n\n* Patients and parents of patients who accept to participate.\n* Teeth having absence of active cavitated-caries lesions, root canal treatment or restorations\n* Teeth with ICDAS code 3 lesions (localized enamel breakdown due to caries with no visible dentin)\n* Teeth that have a previously esthetic procedure (e.g. bleaching)\n* Patients who are not in cooperation with the procedure.\n* Fully erupted teeth with open apices'}, 'identificationModule': {'nctId': 'NCT02896556', 'briefTitle': 'Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Evaluation of Esthetic Performance of Resin Infiltration Technique on Hypomineralized and Demineralized Enamel Lesions', 'orgStudyIdInfo': {'id': 'HUDHF-2-Icon'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resin infiltrate', 'description': 'This is a single-arm study. Resin infiltration technique will be performed to all patients.', 'interventionNames': ['Device: Resin infiltrate']}], 'interventions': [{'name': 'Resin infiltrate', 'type': 'DEVICE', 'description': 'A resin that used for micro-invasive treatment of enamel-restricted, non-cavitated caries or hypo/demineralized smooth enamel surfaces.', 'armGroupLabels': ['Resin infiltrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Zafer C Cehreli, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'zcehreli@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zafer Cavit Cehreli, DDS, PhD', 'investigatorAffiliation': 'Hacettepe University'}}}}