Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toothpaste Product, Varnishes, Fluoride.
- Who it may be relevant to
- Registry conditions: Caries; Initial, Caries Active. Basic parameters: 22 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste, Sodium Fluoride Varnish in Management of White Spot Lesions (A 6m Randomized Clinical Trial).
Overview
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
- Procedure Toothpaste Product
Administration ofa toothpaste - Procedure Varnishes, 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.
Primary outcome measures
- Degree of Remineralization efficacy by Diagnodent [Time frame: change from the baseline, 1month, 3 months , 6 months after treatment]
Secondary outcome measures (2)
- Carie Progression according to International Caries Detection and Assessment System (ICDAS) scale: [Time frame: change from the baseline, 1month, 3 months , 6 months after treatment]
- Patient-reported outcome measures (PROMs): Patients perception of the treatment [Time frame: change from the baseline, 1month, 3 months , 6 months after treatment]
Eligibility criteria
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 .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07120243 · CONS1R