P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions
- Conditions
- White Spot Lesion
- Interventions
- Other: nanosilver fluoride varnishOther: sodium fluoride varnishOther: self-assembling peptide
- Registration Number
- NCT04929509
- Lead Sponsor
- Hams Hamed Abdelrahman
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 66
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
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- Patients receiving the following medications: tetracyclines, any other medication known to stain teeth or any medication causing dry mouth and/or limiting salivary flow. 2. Patients receiving any antibiotic within 1 month prior to each saliva sample collection 3. Selected tooth with microcavities or dentinal involvement due to loss of enamel tissues. 4. Selected tooth with a restoration adjacent to the lesions to avoid false- positive readings. 5. Selected tooth with fluoride application < 3 months prior to study treatment. 6. Selected tooth with discolouration, enamel hypoplasia or fluorosis. 7. Patients with multiple cavitations to avoid variability in microbiological analysis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nanosilver fluoride varnish nanosilver fluoride varnish (Study group) Nano-silver fluoride varnish will be applied to the white spot lesion at baseline. sodium fluoride varnish sodium fluoride varnish (Control group) Fluoride varnish (Duraflor) will be applied to the white spot lesion at baseline and 6 months follow up. self-assembling peptide (P11-4) self-assembling peptide Curodont Repair; Credentis will be applied to the white spot lesion at baseline.
- Primary Outcome Measures
Name Time Method Change in the activity status of lesions scored using ICDAS-LAA 12 months Change in the activity status of lesions scored using ICDAS-LAA from baseline to final follow up.
- Secondary Outcome Measures
Name Time Method Microbial count of mutans streptococci, lactobacilli. 6 months Microbial count of mutans streptococci, lactobacilli.from baseline to each follow up period
Change in mean DIAGNOdent readings. 12 months Change in mean DIAGNOdent readings from baseline to each follow up period
Trial Locations
- Locations (1)
Faculty of dentistry
🇪🇬Alexandria, Egypt