Evaluation of the Effect of Self-Assembling Peptide P11-4

Study Overview
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Brief Summary
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Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that results in the phasic demineralization and remineralization of dental hard tissues. These tissues have poor regeneration capability because of the lack of both regenerative cells and vascularization. In the complex caries progression process involving dietary sugars, bacterial metabolism and demineralization, the collagenous organic matrix becomes exposed and destroyed by resident and bacterial proteases, allowing the lesion to expand

Detailed Description
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It is possible to find numerous noninvasive or minimally invasive therapies for caries such as hygiene education, fluorides, Phosphopeptide compounds, xylitol and infiltrative resins. However, when caries progresses to the point of breaking down the dental tissues, composite restorations are imperative to preserve the tooth functionality. During the execution of routine dental restorations, the hybrid structure formed by the dental bonding procedure occurs through the interaction and subsequent polymerization of monomers around the demineralized collagen matrix. The oral cavity is a severe environment for the resin-dental bond to survive for a reasonable length of time, with thermomechanical changes, chemical attacks by acids and enzymes and other factors posing routine daily challenges. Therefore to achieve effective and stable bonding, the preservation of dentin collagen is critical, since collagen represents the major organic component of the dentin matrix. Based on today's understanding of the dental biomineralization process, new efforts have been made to develop synthetic analogues of non-collagenous proteins (NCPs), which are involved in the events of nucleation and growth of hydroxyapatite crystals in hard tissues Such analogues have been designed mirroring the amphiphilic characteristics of NCPs, with polar groups complexing inorganic ions and non-polar side chains governing the matrix-matrix interactions.

Official Title
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Evaluation of the Remineralizing Effect of Self-assembling Peptide P11-4 on Caries Affected Dentin.

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Peptide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients included in the study will be required to present at least one permanent molar with an active deep carious lesion without pulpal involvement. Age of patient: 18 -30 years Carious lesions will be standardized by means of clinical and radiographic examinations performed before the procedures Exclusion Criteria: Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling Developmental disorders and adjacent soft tissue lesions Patients with systemic illness will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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
Interventional Model Description: To study the effect of self assembling-peptide P11-4 treatment on dentine remineralization, after removal of all infected dentine (Remineralization of caries affected dentin),
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Negative control group (A1)<br>A1: cavities will be sealed directly by restorative material (conventional glass ionomer) without any treatment. | Drug: Peptide<br>* it is about synthetic protein acting on tooth structure help information apatite crystals<br>* Other names: peptide P11-4;|
| Active Comparator: Treatment group (A2)<br>A2: cavities will be treated by Self-Assembling peptide P11-4 then sealed by conventional glass ionomer. | Drug: Peptide<br>* it is about synthetic protein acting on tooth structure help information apatite crystals<br>* Other names: peptide P11-4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization | Assessment of the remineralizing effect of self-assembling peptide P11-4 on affected-caries dentin. Remineralization will be assessed by radiodensity using digital radiography | 3 months |