Caries; InitialNCT07120243
Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste
A study testing Toothpaste Product and Varnishes, Fluoride in people with Caries; Initial and Caries Active, run by Rawda Hesham Abd ElAziz.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries; Initial, Caries Active
- What is being tested?
- Toothpaste Product and Varnishes, Fluoride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
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
- Being tested
- Toothpaste Product, Varnishes, Fluoride
- Keywords
- Bioactive Silica Based with calcium booster (Refix technology) toothpaste, Caries Prevention, white spot carious lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste ProductProcedure or surgery
Administration ofa toothpaste
Varnishes, FluorideProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Toothpaste Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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:
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
Measured: 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".
Measured: change from the baseline, 1month, 3 months , 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries; InitialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawda Hesham Abd ElAziz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rawda Hesham Abd ElAziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120243
- Sponsor's protocol ID
- CONS1R
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT07120243
- Acronym / sponsor ID
- CONS1R
- Conditions
- Caries; Initial, Caries Active
- Keywords
- Bioactive Silica Based with calcium booster (Refix technology) toothpaste, Caries Prevention, white spot carious lesions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rawda Hesham Abd ElAzizUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Refix Booster: Bioactive Silica Based (Refix technology) with calcium booster toothpaste | Experimental | Procedure: Toothpaste ProductThe 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. |
| Group 2 Polimo: 5% Sodium Fluoride varnish | Experimental | Procedure: Varnishes, FluorideThe 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. |
| Group (3) Signal Complete 8 ; Conventional 1425 ppm fluoride toothpaste: | Active comparator | Procedure: Toothpaste ProductThe 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. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste ProductAdministration ofa toothpaste | Procedure or surgery | Group (3) Signal Complete 8 ; Conventional 1425 ppm fluoride toothpaste:, Group 1 Refix Booster: Bioactive Silica Based (Refix technology) with calcium booster toothpaste |
| Varnishes, FluorideThe 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. | Procedure or surgery | Group 2 Polimo: 5% Sodium Fluoride varnish |
Primary outcome
Degree of Remineralization efficacy by Diagnodent
Time frame: 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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste Product and Varnishes, Fluoride in people with Caries; Initial and Caries Active, run by Rawda Hesham Abd ElAziz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rawda Hesham Abd ElAziz (+201001097200, rawda.hesham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Remineralization efficacy by Diagnodent (time frame: change from the baseline, 1month, 3 months , 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.