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Background: Great efforts have been undertaken for dental caries prevention. Among the recent remineralizing materials, Nano silver fluoride varnish products which are based on nanotechnology have been proposed for "repairing" enamel . Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy using Self-Assembling Peptide P11-4 (Curodont Repair) which enhances remineralization of white spot lesions. Purpose of the Study: The aim of this study is to compare clinically and microbiologically the therapeutic effect of Self Assembling Peptide P11-4 (Curodont Repair), nano silver fluoride varnish and 5% fluoride varnish (Duraflor) on remineralization of enamel White Spot Lesions in permanent teeth of adults.
The study will be a randomized controlled double-blinded study conducted on participants aged 10 to 24 years satisfying the inclusion criteria with visible active white spot lesions on buccal surfaces of permanent teeth. Sixty six patients will be randomly allocated into 3 groups of the three materials: study group 1: one application of Curodont Repair, study group 2: one application of Nano-silver fluoride varnish and Control group twice application of Fluoride Varnish (Duraflor).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| self-assembling peptide (P11-4) | Experimental | Curodont Repair; Credentis will be applied to the white spot lesion at baseline. |
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| nanosilver fluoride varnish | Active Comparator | (Study group) Nano-silver fluoride varnish will be applied to the white spot lesion at baseline. |
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| sodium fluoride varnish | Placebo Comparator | (Control group) Fluoride varnish (Duraflor) will be applied to the white spot lesion at baseline and 6 months follow up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-assembling peptide | Other | each Curodont Repair applicator unit contains both Curolox technology for guided enamel regeneration and water for activation of the device, each box contains 10 applicators |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the activity status of lesions scored using ICDAS-LAA | Change in the activity status of lesions scored using ICDAS-LAA from baseline to final follow up. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean DIAGNOdent readings. | Change in mean DIAGNOdent readings from baseline to each follow up period | 12 months |
| Microbial count of mutans streptococci, lactobacilli. | Microbial count of mutans streptococci, lactobacilli.from baseline to each follow up period |
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Inclusion Criteria:
1- An age range of 10-24 years ( age of young adolescents and youth as described by the WHO was selected (WHO, 2019). 2. The presence of at least one visible WSL in the buccal surface of permanent teeth with ICDAS II score of 1, or 2. 3. Completion of an informed consent to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hala A Amer, PHD | Alexandria University | Study Director |
| Susan M Saleh, PHD | Alexandria University | Principal Investigator |
| Yara S Selim, PHD | Alexandria University | Principal Investigator |
| Sara M Atteya, PHD | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry | Recruiting | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38388987 | Derived | Atteya SM, Amer HA, Saleh SM, Safwat Y. The effect of nano silver fluoride, self-assembling peptide and sodium fluoride varnish on salivary cariogenic bacteria: a randomized controlled clinical trial. Clin Oral Investig. 2024 Feb 23;28(3):167. doi: 10.1007/s00784-024-05562-0. | |
| 37598194 | Derived | Atteya SM, Amer HA, Saleh SM, Safwat Y. Self-assembling peptide and nano-silver fluoride in remineralizing early enamel carious lesions: randomized controlled clinical trial. BMC Oral Health. 2023 Aug 19;23(1):577. doi: 10.1186/s12903-023-03269-4. |
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| ID | Term |
|---|---|
| C094502 | Bifluorid 12 |
| C120870 | Duraflor |
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| nanosilver fluoride varnish | Other | The synthesis of aqueous solution of silver nanoparticles will be carried out via the chemical reduction of silver nitrate (1 mL, 0.11 M) with sodium borohydride (0.3 mL, 0.8 M) and chitosan biopolymer (28.7 mL, 2.5 mg/mL) as a stabilizing agent. Sodium fluoride (10,147 ppm of fluorine) will be incorporated at the end of the experiment. |
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| sodium fluoride varnish | Other | 5% sodium fluoride varnish; One ml of fluoride varnish contains 50 mg of sodium fluoride in an alcohol-based suspension of resins. |
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| 6 months |