[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657802":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":24,"studyPopulation":15,"armGroups":25,"interventions":48,"overallOfficials":65,"centralContacts":69,"locations":75,"responsibleParty":97,"collaborators":15,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":15,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":15,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":78,"whyStopped":15,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Alexandria University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":15},[9],{"measure":10,"description":10,"timeFrame":11},"The primary outcome of this study will be to assess caries arrest status by assessing lesion severity and activity using (ICDAS-II) criteria and the change in mean DIAGNOdentTM readings at 1, 3 and 6 months follow up .","6 months",[13],{"measure":14,"description":14,"timeFrame":11},"• Assessment of the change in lesion surface area using standardized photographic assessment at 6 months follow up.",null,{"allocation":17,"interventionModel":18,"interventionModelDescription":15,"primaryPurpose":19,"observationalModel":15,"timePerspective":15,"maskingInfo":20},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":21,"maskingDescription":15,"whoMasked":22},"SINGLE",[23],"OUTCOMES_ASSESSOR","White spot lesions (WSLs) are early manifestations of enamel caries characterized by subsurface mineral loss while the enamel surface remains clinically intact. In primary teeth, early lesions may progress rapidly, making non-invasive remineralization an important approach for preserving tooth structure and preventing progression to cavitation. Fluoride varnish is widely used for the management of early enamel lesions; however, conventional fluoride varnishes may have limited retention on the tooth surface and may primarily promote remineralization near the enamel surface.\n\nBioactive glass-containing materials have been developed as an alternative or adjunctive remineralization strategy. Biomin fluoride varnish incorporates bioactive glass capable of releasing calcium, phosphate, and fluoride ions in the oral environment. According to the protocol, the sustained release of these ions may promote formation of fluorapatite and potentially provide deeper and longer-lasting remineralization of early enamel lesions.\n\nLow-level diode laser irradiation has also been proposed as an adjunct to topical fluoride treatment. The protocol describes laser irradiation as potentially increasing enamel resistance to acid attack and enhancing fluoride uptake. However, previous findings cited in the protocol are not consistent: some studies have suggested a synergistic effect between laser irradiation and remineralizing agents, whereas other studies have not demonstrated an additional benefit when laser treatment is combined with fluoride or Biomin products. The protocol therefore identifies a need for clinical evaluation of these approaches in primary teeth.\n\nThis study is designed as a four-arm, parallel, randomized controlled clinical trial. Participants meeting the study criteria will be randomly allocated to receive one of the study treatment approaches. The allocation will be computer-generated with an equal allocation ratio, and treatment assignment will be concealed until the intervention. The outcome assessor will remain blinded to treatment allocation.\n\nThe study will evaluate the clinical and quantitative changes occurring in active, non-cavitated white spot lesions during a 6-month follow-up period. Lesion status will be monitored using clinical assessment with the International Caries Detection and Assessment System (ICDAS-II) and quantitative assessment using laser-induced fluorescence with the DIAGNOdent™ pen. These assessments will allow changes in lesion severity, activity, and fluorescence readings to be followed over time. Standardized photographic records will additionally be used at the end of follow-up to evaluate changes in the proportional surface area of the lesions.\n\nBefore treatment, eligible lesions will undergo baseline assessment following cleaning and standardized examination procedures. The investigator will be trained and calibrated in the use of ICDAS-II and DIAGNOdent™. Lesion activity will be assessed clinically, while DIAGNOdent measurements will provide numerical readings related to enamel demineralization. Standardized photographs will be obtained under controlled conditions to permit subsequent comparison of lesion size.\n\nThe assigned varnish will be applied according to the manufacturer's instructions. For participants allocated to the laser groups, the diode laser will be applied following varnish application using the parameters specified in the study protocol. Participants will receive post-treatment instructions concerning fluoride-containing products and eating and drinking following varnish application. At the 3-month visit, the assigned treatment will be reapplied, followed by the same post-application instructions.\n\nFollow-up examinations will take place at predetermined intervals during the 6-month study period. Clinical and DIAGNOdent assessments will be repeated during follow-up, while standardized photographic assessment will be performed at the final visit. All follow-up assessments will be conducted by the same calibrated examiner, who will remain unaware of the treatment allocation.\n\nThe study is intended to determine whether the incorporation of bioactive glass into a fluoride varnish and\u002For the addition of low-level diode laser irradiation is associated with greater improvement in early white spot lesions than conventional fluoride varnish alone. The findings are expected to provide clinical evidence regarding the use of these non-invasive approaches for the management of early carious lesions in primary teeth.\n\nThe protocol states that written informed consent will be obtained from the parent or guardian before participation. The study activities will be conducted in accordance with the ethical requirements of the Faculty of Dentistry, Alexandria University, and the Declaration of Helsinki. Participants and their guardians will also receive oral hygiene and dietary instructions as part of the study procedures. The protocol reports that no study-related hazards or side effects are anticipated.",[26,32,37,42],{"label":27,"type":28,"description":29,"interventionNames":30},"Test group 1","EXPERIMENTAL","• Group I (Test Group I): BioMin® fluoride varnish: 5% NaF varnish incorporating bioactive glass (calcium\u002Fphosphate releasing).\n\nwill be applied according to the manufacturer's instructions as follows\n\n1. Excess plaque should be removed\n2. Teeth should be isolated and gently dried\n3. BioMin fluoride varnish will be applied using a disposable microbrush in thin layer and allowed to set",[31],"Other: BioMin® fluoride varnish: 5% NaF varnish incorporating bioactive glass (calcium\u002Fphosphate releasing).",{"label":33,"type":28,"description":34,"interventionNames":35},"Test group 2","(BioMin® + Diode Laser): After application of BioMin® fluoride varnish as described above, the tooth surface will be irradiated using a diode laser with the following parameters:\n\n* Wavelength: 980 nm.\n* Operating Mode: Continuous wave.\n* Fiber tip:320 µm.\n* Radiant Energy :15 J.\n* Mode: Non-contact mode.\n* Duration: 30 seconds.\n* Laser safety eyewear: OD ≥ 5 at 980 nm for operator, patient, and assistant.",[36],"Other: (BioMin® + Diode Laser)",{"label":38,"type":28,"description":39,"interventionNames":40},"Test group 3","(Duraphat varnish + Diode laser ): After application of DURAPHAT fluoride varnish as described above, the tooth surface will be irradiated using a diode laser with the following parameters:\n\n* Wavelength: 980 nm.\n* Operating Mode: Continuous wave.\n* Fiber tip:320 µm.\n* Mode: Non-contact mode.\n* Duration: 30 seconds.\n* Radiant Energy: 15 J.\n* Laser safety eyewear: OD ≥ 5 at 980 nm for operator, patient, and assistant.",[41],"Other: (Duraphat varnish + Diode laser)",{"label":43,"type":44,"description":45,"interventionNames":46},"Control group","ACTIVE_COMPARATOR","Duraphat varnish (5% sodium fluoride varnish) will be applied to all white spot lesions according to the manufacturers' instructions as follows:\n\n1. Excess plaque should be removed\n2. Teeth should be isolated and gently dried\n3. Duraphat can be applied using a brush in a thin layer on the affected areas and allowed to set.",[47],"Other: Duraphat varnish (5% sodium fluoride varnish)",[49,53,57,61],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":15},"BioMin® fluoride varnish: 5% NaF varnish incorporating bioactive glass (calcium\u002Fphosphate releasing).","will be applied according to the manufacturer's instructions as follows\n\n1. Excess plaque should be removed\n2. Teeth should be isolated and gently dried\n3. BioMin fluoride varnish will be applied using a disposable microbrush in thin layer and allowed to set",[27],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":15},"(BioMin® + Diode Laser)","* After application of BioMin® fluoride varnish as described above, the tooth surface will be irradiated using a diode laser Wavelength: 980 nm.\n* Operating Mode: Continuous wave.\n* Fiber tip:320 µm.\n* Radiant Energy :15 J.\n* Mode: Non-contact mode.\n* Duration: 30 seconds.\n* Laser safety eyewear: OD ≥ 5 at 980 nm for operator, patient, and assistant.",[33],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":15},"(Duraphat varnish + Diode laser)","After application of DURAPHAT fluoride varnish as described above, the tooth surface will be irradiated using a diode laser with the following parameters(16):\n\n* Wavelength: 980 nm.\n* Operating Mode: Continuous wave.\n* Fiber tip:320 µm.\n* Mode: Non-contact mode.\n* Duration: 30 seconds.\n* Radiant Energy: 15 J.\n* Laser safety eyewear: OD ≥ 5 at 980 nm for operator, patient, and assistant.",[38],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":15},"Duraphat varnish (5% sodium fluoride varnish)","will be applied to all white spot lesions according to the manufacturers' instructions as follows:\n\n1. Excess plaque should be removed\n2. Teeth should be isolated and gently dried\n3. Duraphat can be applied using a brush in a thin layer on the affected areas and allowed to set.",[43],[66],{"name":67,"affiliation":5,"role":68},"Dalia Mamdouh Talaat, professor","STUDY_DIRECTOR",[70],{"name":71,"role":72,"phone":73,"phoneExt":15,"email":74},"Yassmin Mohamed Hassan, BDs","CONTACT","+20 01005364640","yassmin.moh150@gmail.com",[76,90],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":15},"Faculty of Dentistry, Alexandria university, Egypt","RECRUITING","Alexandria","Alexandria Governorate","21519","Egypt","EG",{"type":85,"coordinates":86},"Point",[87,88],29.91582,31.20176,{"lat":88,"lon":87},{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},{"type":85,"coordinates":92},[87,88],{"lat":88,"lon":87},[95],{"name":71,"role":72,"phone":96,"phoneExt":15,"email":74},"+20 1005364640",{"type":98,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"SPONSOR_INVESTIGATOR","Yassmin Mohamed","Pediatric Dentistry Resident at Faculty of Dentistry Alexandria University","100657802","efficacy-of-biomin-fluoride-versus-sodium-fluoride-varnishes-with-and-without-diode-laser-on-white-spot-lesions-remineralization-in-primary-teeth-a-randomized-controlled-clinical-trial-100657802",false,"NCT07845110","EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.","EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH (A RANDOMIZED CONTROLLED CLINICAL TRIAL)","Inclusion Criteria:\n\n* • Healthy Children aged 3-6 years old.\n\n  * Patients ranking definitely positive or positive on Frankel scale\n  * The Presence of at least one active non-cavitated white spot lesion (ICDAS code 1 or 2) on the facial surface of primary teeth .\n  * Completion of an informed consent by the guardian to participate in the study\n* exclusion criteria:\n\n  * History of systemic disease or medication affecting enamel development\n  * Teeth with cavitated lesions (ICDAS ≥ 3)\n  * Previous professional fluoride treatment or laser therapy in the last 3 months","ALL","3 Years","6 Years",{"count":112,"type":113},80,"ESTIMATED","INTERVENTIONAL",[116],"NA","The goal of this randomized controlled clinical trial is to assess and compare the remineralizing effect of Biomin fluoride varnish and conventional 5% sodium fluoride varnish (Duraphat), with and without adjunctive low-level diode laser irradiation, in preschool children with active white spot lesions in primary anterior teeth. The study will include healthy children aged 3-6 years with at least one active, non-cavitated white spot lesion (ICDAS-II score 1 or 2). The study will be conducted at the Faculty of Dentistry, Alexandria University, with a total of 80 lesions randomly allocated to four parallel groups.\n\nThe main questions it aims to answer are:\n\nDoes Biomin fluoride varnish produce a different remineralizing effect compared with conventional 5% sodium fluoride varnish (Duraphat) after 6 months? Does adding 980-nm low-level diode laser irradiation to Biomin fluoride varnish or Duraphat improve the remineralization of white spot lesions compared with the corresponding varnish alone? Do the different treatments result in changes in lesion severity and activity, as assessed by ICDAS-II and DIAGNOdent readings? Do the treatments reduce the surface area of white spot lesions after 6 months?\n\nResearchers will compare four treatment groups to assess differences in remineralization:\n\nGroup I (n=20): Biomin fluoride varnish (5% sodium fluoride incorporating bioactive glass).\n\nGroup II (n=20): Biomin fluoride varnish combined with low-level diode laser. Group III (n=20): Duraphat 5% sodium fluoride varnish combined with low-level diode laser.\n\nGroup IV (n=20): Duraphat 5% sodium fluoride varnish alone (control group).\n\nParticipants will:\n\nUndergo baseline assessment of their white spot lesions using ICDAS-II visual-tactile examination, DIAGNOdent laser fluorescence, and standardized photographic assessment.\n\nReceive the randomly assigned fluoride varnish treatment, with diode laser irradiation applied to Groups II and III using a 980-nm diode laser.\n\nReturn for follow-up assessments at 1, 3, and 6 months. At 3 months, the assigned varnish and laser treatment will be reapplied according to the group.\n\nHave lesion severity and activity assessed using ICDAS-II and changes in mineralization assessed through DIAGNOdent readings. At 6 months, standardized photographs will also be used to evaluate changes in lesion surface area.\n\nFollow post-treatment instructions, including avoiding fluoride-containing products on the day of varnish application and avoiding eating and drinking for at least 4 hours.\n\nThe primary outcome is caries arrest\u002Fremineralization assessed through changes in lesion severity and activity using ICDAS-II and changes in mean DIAGNOdent readings at 1, 3, and 6 months. The secondary outcome is the change in white spot lesion surface area measured by standardized photographic assessment at 6 months.",[119],"White Spot Lesions [Initial Caries] on Smooth Surface of Tooth",[121],"Remineralization Primary Anterior Teeth Fluoride Varnish BioMin Fluoride Diode Laser","2026-09-27",{"date":124,"type":125},"2026-09-30","ACTUAL",{"date":127,"type":113},"2026-10-01",{"date":129,"type":113},"2027-04-01",{"name":99,"class":6},2]