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

Hams Hamed Abdelrahman

Status: Unknown

Conditions: White Spot Lesion

Treatments: Other: sodium fluoride varnish; Other: self-assembling peptide; Other: nanosilver fluoride varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT04929509

P11-4 in white spot lesions

Details and patient eligibility

About

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.

Full 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).

Enrollment: 66 estimated patients

Sex: All

Ages: 10 to 24 years old

Volunteers: Accepts Healthy Volunteers

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 < 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

66 participants in 3 patient groups, including a placebo group

self-assembling peptide (P11-4)

Experimental group

Description:

Curodont Repair; Credentis will be applied to the white spot lesion at baseline.

Treatment:

Other: self-assembling peptide

nanosilver fluoride varnish

Active Comparator group

Description:

(Study group) Nano-silver fluoride varnish will be applied to the white spot lesion at baseline.

Treatment:

Other: nanosilver fluoride varnish

sodium fluoride varnish

Placebo Comparator group

Description:

(Control group) Fluoride varnish (Duraflor) will be applied to the white spot lesion at baseline and 6 months follow up.

Treatment:

Other: sodium fluoride varnish