About this trial
This study will be conducted to Clinically evaluate Bioactive Silica Based with calcium booster (Refix technology) toothpaste and Sodium Fluoride varnish versus conventional fluoride toothpastes in management of white spot lesions of adult patients over 6m follow up and evaluating patient perception regarding the treatment provided.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient with non cavitated carious WSL in at least one upper or lower tooth.
Teeth with active non cavitated white spot carious lesions on the cervical one third of the facial or lingual surfaces.
Disqualifiers
Presence of surface cavitation or restorations .
Trial design
Parallel
Treatments tested in this trial
Toothpaste Product
Procedure/SurgeryAdministration ofa toothpaste
Varnishes, Fluoride
Procedure/SurgeryThe tooth will be dried, and cotton roll isolated. According to manufacturer instructions, thin coat of the varnish will be applied on the teeth for 10 - 20 s using a microbrush in a horizontal sweeping motion , then drying with air will be done.
Treatment groups
Trial outcomes
Primary outcomes
Degree of Remineralization efficacy by Diagnodent
DIAGNOdent calibration will be performed first then the tip of the probe will be positioned on the lesion and rotated around its vertical axis until the highest value will be reached and a peak reading will be recorded
Secondary outcomes
Carie Progression according to International Caries Detection and Assessment System (ICDAS) scale:
The tooth will be visually examined according to the ICDAS scale as follows: "Code 0: Sound tooth surface: There should be no evidence of caries. Code 1: First visual change in enamel: When seen wet there is no evidence of any change in color attributable to carious activity, but after prolonged air drying a carious opacity (white or brown lesion) is visible that is not consistent with the clinical appearance of sound enamel. Code 2: Distinct visual change in enamel when viewed wet: There is a carious opacity or discoloration (white or brown lesion) that is not consistent with the clinical appearance of sound enamel. This lesion may be seen directly when viewed from the buccal or lingual direction. In addition, when viewed from the occlusal direction, this opacity or discoloration may be seen as a shadow confined to enamel, seen through the marginal ridge. Code 3: Initial breakdown in enamel due to caries with no visible dentin: Once dried for approximately five seconds there is disti
Patient-reported outcome measures (PROMs): Patients perception of the treatment
Patients will be evaluated regarding their perception of the treatment provided outcome using Global Impression of Change Questionnaire (GICQ) which is a seven-point scale describing the overall impression of the patients toward the treatment of the lesions and change from the baseline as follows: 'very much worse', 'worse', 'a little worse', 'unchanged', 'a little better', 'better', 'very much better'. satisfied".
Locations
Sponsors and contacts
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Rawda Hesham Abd ElAziz
Lead sponsor
Cairo University
Sponsor institution
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