Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste

Rawda Hesham Abd ElAziz

Status: Not yet enrolling

Conditions: Caries; Initial; Caries Active

Treatments: Procedure: Varnishes, Fluoride; Procedure: Toothpaste Product

Study type: Interventional

Funder types: Other

Identifiers

NCT07120243

CONS1R

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 22 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 3 patient groups

Group 1 Refix Booster: Bioactive Silica Based (Refix technology) with calcium booster toothpaste

Experimental group

Description:

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.

Treatment:

Procedure: Toothpaste Product

Group 2 Polimo: 5% Sodium Fluoride varnish

Experimental group

Description:

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.

Treatment:

Procedure: Varnishes, Fluoride

Group (3) Signal Complete 8 ; Conventional 1425 ppm fluoride toothpaste:

Active Comparator group

Description:

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.

Treatment:

Procedure: Toothpaste Product