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Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.
This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self assembling peptide P11-4 with fluoride | Experimental | P11-4 forms a 3D matrix within subsurface of incipient carious lesions , allowing formation of new hydroxyapatite crystal facilitating guided regeneration of enamel lesions. Combination with fluoride will have a synergistic effect on remineralization potential |
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| Fluoride varnish | Active Comparator | Gold standard agent for remineralization of incipient carious lesions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curodont Repair Fluoride Plus | Combination Product | P11-4 self assembling peptide combined with fluoride |
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| Measure | Description | Time Frame |
|---|---|---|
| Remineralization | measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar O Shaalan, PhD | Contact | 00201122665661 | omar.shaalan@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Omar O Shaalan, PhD | Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | El Manial | 11553 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39037455 | Derived | Shaalan O, Fawzy El-Sayed K, Abouauf E. Evaluation of the remineralization potential of self-assembling peptide P11-4 with fluoride compared to fluoride varnish in the management of incipient carious lesions: a randomized controlled clinical trial. Clin Oral Investig. 2024 Jul 22;28(8):438. doi: 10.1007/s00784-024-05822-z. |
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| Bifluorid 10 fluoride varnish | Other | 5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride) |
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