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| Name | Class |
|---|---|
| Al-Azhar University | OTHER |
| University of Science and Technology of Fujairah | UNKNOWN |
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Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions
Patient/population:
Patients that range from 7-14 years of age with with at least one non-cavitated WSL located on smooth surfaces of maxillary or mandibular permanent teeth and comparable in size, opacity, and whitish appearance.
Intervention:
I1: Self-Assembling Peptide (P11-4) I2: Self-Assembling Peptide (P11-4) with fluoride varnish
Comparator Resin Infiltration
Outcome:
Primary outcome
Outcome measure: Photographic analysis Outcome measuring Device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software.
Outcome measuring unit: change in Percentage
• Tooth remineralization
Outcome measure: International Caries Detection and Assessment System (ICDAS) score.
Outcome measuring Device: Visual and Clinical examination by operator Outcome measuring Unit : Numerical score from 0-6
Outcome measure: Quantitative light Fluorescence score from WSL Outcome measuring Device: Diagnodent Pen Outcome measuring Unit: Numerical score from 0-99
Secondary outcome
Outcome measure: Patient Satisfaction Outcome measuring Device Likert 5-point faces scale ranging from very sad to very happy
Outcome measuring Unit :Numerical score from 1-5
Study design: Randomized clinical trial Time: 6 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Assembling Peptide (P11-4) | Experimental | self-assembling peptide in a brush-on liquid applied after cleaning and chemical preparation.The P11-4 peptide, called Curodont Repair (Credentis; now manufactured by vVARDIS) |
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| Self-Assembling Peptide (P11-4) with fluoride varnish | Experimental | CR Fluoride Plus (CRFP) (Credentis; now manufactured by vVARDIS) also includes 500 ppm sodium fluoride and is registered with the US Food and Drug Administration (NDC 72247-101) as an anticaries drug under the fluoride monograph (21CFR355). |
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| Resin Infilteration | Active Comparator | ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P11-4, a self-assembling peptide | Drug | rationally designed peptide, the monomers of which self-assemble into a biocompatible fibrillar scaffold that mimics the enamel matrix in response to particular environmental cues |
| Measure | Description | Time Frame |
|---|---|---|
| Esthetic Improvement of white spot lesion | Outcome Measure: Photographic analysis Outcome measuring device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software Outcome measuring unit: Percentage change | 6 months |
| Tooth remineralization | ICDAS score Outcome Measure: ICDAS score Outcome measuring device: Visual and Clinical examination by operator Outcome measuring unit: Numerical value from 0-6 Outcome Measure: Quantitative Light Fluorescence score from WSL Outcome measuring device: Diagnodent pen Outcome measuring unit: Numerical value ranging from 0 to 99 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Likert 5-point faces scale ranging from very sad to very happy | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina El Kharadly, PHD | Contact | 02 38355276 | dina.yousry.dent@o6u.edu.eg | |
| nada adel | Contact | 02 38355276 | nada.adel.dent@o6u.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| October 6 University | Recruiting | Cairo | Giza Governorate | Egypt |
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| ID | Term |
|---|---|
| C578177 | icon infiltrant |
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Double Blind
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| P11-4, a self-assembling peptide with flouride | Drug | self assembling peptide with 500 ppm sodium fluoride |
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| resin infilteration | Drug | Improvement of white spot lesions appearance by infiltration occurs due to a change in the refractive index since the refractive index of enamel (1.62-1.65) is different than that of air (1.00). Infiltration of the lesions with an infiltrate that has a refractive index of 1.52 is able to mask the lesion |
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