Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride

Cairo University (CU)

Status: Unknown

Conditions: Caries; Initial

Treatments: Combination Product: Curodont Repair Fluoride Plus; Other: Bifluorid 10 fluoride varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT05094492

p11-4

Details and patient eligibility

About

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.

Full 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).

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Self assembling peptide P11-4 with fluoride

Experimental group

Description:

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

Treatment:

Combination Product: Curodont Repair Fluoride Plus

Fluoride varnish

Active Comparator group

Description:

Gold standard agent for remineralization of incipient carious lesions.

Treatment:

Other: Bifluorid 10 fluoride varnish