Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Caries; Initial

Intervention / Treatment
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* Combination Product: Curodont Repair Fluoride Plus
* Other: Bifluorid 10 fluoride varnish


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self assembling peptide P11-4 with fluoride<br>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 | Combination Product: Curodont Repair Fluoride Plus<br>* P11-4 self assembling peptide combined with fluoride<br>|
| Active Comparator: Fluoride varnish<br>Gold standard agent for remineralization of incipient carious lesions. | Other: Bifluorid 10 fluoride varnish<br>* 5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization | measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion | 6 months |