NCT05094492

Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride

Evaluation of Remineralization Potential of Self Assembling Peptide P11-4 Combined With Fluoride Compared to Fluoride Varnish in Management of Incipient Carious Lesions Using Laser Fluorescence: Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.

Detailed description

This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).

Conditions

• Caries; Initial

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Curodont Repair Fluoride Plus	P11-4 self assembling peptide combined with fluoride
OTHER	Bifluorid 10 fluoride varnish	5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)

Timeline

• Start date: 2021-10-30
• Primary completion: 2022-04-30
• Completion: 2022-06-30
• First posted: 2021-10-26
• Last updated: 2021-10-26

Locations

1 site across 1 country: Egypt