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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Refix Booster: Bioactive Silica Based (Refix technology) with calcium booster toothpaste | Experimental | The patients will be taught in the intervention visit and instructed to use the same 1 inch amount of the two toothpastes, mix them and apply it on a soft bristle toothbrushes with the same brushing technique they for 2 minutes twice a day (morning and last thing at night) along the study period without further rinsing, only spitting of the excess material. |
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| Group 2 Polimo: 5% Sodium Fluoride varnish | Experimental | The 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. Patients will be instructed to avoid food and liquid intake for two hours after varnish application also, to use conventional 1425 ppm fluoride toothpaste at home with the same instructions mentioned before. |
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| Group (3) Signal Complete 8 ; Conventional 1425 ppm fluoride toothpaste: | Active Comparator | The patients will be taught in the intervention visit and instructed to use the same 1 inch amount of the toothpaste and soft bristle toothbrushes with the same brushing technique they for 2 minutes twice a day (morning and last thing at night) along the study period without further rinsing, only spitting of the excess material. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste Product | Procedure | Administration ofa toothpaste |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | change from the baseline, 1month, 3 months , 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Teeth with initial carious lesions with score 1 or 2 according to The International Caries Detection and Assessment System (ICDAS).
• Teeth with Diagnodent values between 14-20 that refers to early enamel caries.
Exclusion Criteria:
Patients with known allergies or adverse reactions to any ingredient of the tested materials.
• Systematic disease and/ or physical disabilities that may affect participation.
• Patients with white spots due to congenital reasons e.g. enamel hypomineralization.
• Pregnant females with frequent vomiting attacks.
• Smokers.
• Excessive dietary or environmental exposure to acids.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rawda Hesham Abd ElAziz | Contact | +201001097200 | rawda.hesham@dentistry.cu.edu.eg |
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| ID | Term |
|---|---|
| D005460 | Fluorides, Topical |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Varnishes, Fluoride | Procedure | The 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. |
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| change from the baseline, 1month, 3 months , 6 months after treatment |
| 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". | change from the baseline, 1month, 3 months , 6 months after treatment |
| D002327 |
| Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |