Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste

NCT07120243 | Not Yet Recruiting DMC

• 1 other identifier: CONS1R
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caries; Initial; Caries Active

Keywords

Bioactive Silica Based with calcium booster (Refix technology) toothpaste; Caries Prevention; white spot carious lesions

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Carie Progression according to International Caries Detection and Assessment System (ICDAS) scale:

  change from the baseline, 1month, 3 months , 6 months after treatment

• Patient-reported outcome measures (PROMs): Patients perception of the treatment

  change from the baseline, 1month, 3 months , 6 months after treatment

Study Arms (3)

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.

Procedure: Toothpaste Product

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.

Procedure: Varnishes, Fluoride

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.

Procedure: Toothpaste Product

Interventions

Toothpaste Product PROCEDURE

Administration ofa toothpaste

Group (3) Signal Complete 8 ; Conventional 1425 ppm fluoride toothpaste:; Group 1 Refix Booster: Bioactive Silica Based (Refix technology) with calcium booster toothpaste

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.

Group 2 Polimo: 5% Sodium Fluoride varnish

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Rawda Hesham Abd ElAziz: lead

MeSH Terms

Interventions

Fluorides, Topical

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Rawda Hesham Abd ElAziz

CONTACT

+201001097200; rawda.hesham@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Conservative dentistry department

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: August 13, 2025
• Study Start: August 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share