P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04929509

P11-4 in white spot lesions

Ages 10-24
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

1- An age range of 10-24 years ( age of young adolescents and youth as described by the WHOwas selected (WHO, 2019). 2. The presence of at least one visible WSL in the buccal surfaceof permanent teeth with ICDAS II score of 1, or 2. 3. Completion of an informed consent toparticipate in the study

Exclusion

Exclusion Criteria:

1. Patients receiving the following medications: tetracyclines, any other medicationknown to stain teeth or any medication causing dry mouth and/or limiting salivaryflow. 2. Patients receiving any antibiotic within 1 month prior to each saliva samplecollection 3. Selected tooth with microcavities or dentinal involvement due to loss ofenamel tissues. 4. Selected tooth with a restoration adjacent to the lesions to avoidfalse- positive readings. 5. Selected tooth with fluoride application < 3 monthsprior to study treatment. 6. Selected tooth with discolouration, enamel hypoplasia orfluorosis. 7. Patients with multiple cavitations to avoid variability inmicrobiological analysis.

Study Design

December 05, 2020

January 01, 2022

Study 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).

Connect with a study center

Faculty of dentistry
Alexandria,
Egypt
Active - Recruiting

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