Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride

Not Applicable

• Conditions: Caries; Initial
• Interventions: Other: Bifluorid 10 fluoride varnish; Combination Product: Curodont Repair Fluoride Plus

• Registration Number: NCT05094492
• Lead Sponsor: Cairo University

Brief 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).

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-14
• Last Update Submitted: 2021-10-14
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-10-26
• Study Start: 2021-10-30
• Primary Completion: 2022-04-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Active carious white spot lesions.
• Patient compliance.
• Controlled oral hygiene condition.

Exclusion Criteria

• Participant in another trial.
• Non carious lesions.
• Systemic diseases or concomitant medication affecting salivary flow.
• Cavitation of carious lesions.
• Parafunctional habits.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoride varnish	Bifluorid 10 fluoride varnish	Gold standard agent for remineralization of incipient carious lesions.
Self assembling peptide P11-4 with fluoride	Curodont Repair Fluoride Plus	P11-4 forms a 3D matrix within subsurface of incipient carious lesions , allowing formation of new hydroxyapatite crystal facilitating guided regeneration of enamel lesions. Combination with fluoride will have a synergistic effect on remineralization potential

Primary Outcome Measures

Name	Time	Method
Remineralization	6 months	measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, El Manial, Egypt