NCT04929509

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Hams Hamed Abdelrahman · Academic / Other
• Sex: All
• Age: 10 Years – 24 Years
• Healthy volunteers: Accepted

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).

Conditions

• White Spot Lesion

Interventions

Type	Name	Description
OTHER	self-assembling peptide	each Curodont Repair applicator unit contains both Curolox technology for guided enamel regeneration and water for activation of the device, each box contains 10 applicators
OTHER	nanosilver fluoride varnish	The synthesis of aqueous solution of silver nanoparticles will be carried out via the chemical reduction of silver nitrate (1 mL, 0.11 M) with sodium borohydride (0.3 mL, 0.8 M) and chitosan biopolymer (28.7 mL, 2.5 mg/mL) as a stabilizing agent. Sodium fluoride (10,147 ppm of fluorine) will be incorporated at the end of the experiment.
OTHER	sodium fluoride varnish	5% sodium fluoride varnish; One ml of fluoride varnish contains 50 mg of sodium fluoride in an alcohol-based suspension of resins.

Timeline

• Start date: 2020-12-05
• Primary completion: 2021-10-05
• Completion: 2022-01-01
• First posted: 2021-06-18
• Last updated: 2021-06-18

Locations

1 site across 1 country: Egypt