Clinical trial NCT04929509: P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions
Official title: Effectiveness of Self-assembling Peptide (P11-4) and Nano-silver Fluoride Varnish in Management of Enamel White Spot Lesions in Young People (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: White Spot Lesion
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 66
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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:

* 1. 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 \&lt; 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.

Primary outcomes:
measure: Change in the activity status of lesions scored using ICDAS-LAA
timeFrame: 12 months
Secondary outcomes:
measure: Change in mean DIAGNOdent readings.
timeFrame: 12 months
measure: Microbial count of mutans streptococci, lactobacilli.
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of dentistry
Study officials:
affiliation: Alexandria University
name: Hala A Amer, PHD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Susan M Saleh, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Yara S Selim, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Sara M Atteya, PHD
role: PRINCIPAL_INVESTIGATOR
References: