Caries; Initial, Caries Active
Conditions
Keywords
Bioactive Silica Based with calcium booster (Refix technology) toothpaste, Caries Prevention, white spot carious lesions
Brief summary
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.
Interventions
PROCEDUREToothpaste Product
Administration ofa toothpaste
PROCEDUREVarnishes, Fluoride
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.
Sponsors
Rawda Hesham Abd ElAziz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. 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. * Presence of surface cavitation or restorations .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Remineralization efficacy by Diagnodent | change from the baseline, 1month, 3 months , 6 months after treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Carie Progression according to International Caries Detection and Assessment System (ICDAS) scale: | change from the baseline, 1month, 3 months , 6 months after treatment | 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 | change from the baseline, 1month, 3 months , 6 months after 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. |
Contacts
Primary ContactRawda Hesham Abd ElAziz
Outcome results
None listed