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

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

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

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Drug: Peptide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistary - Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Principal Investigator: Asmaa Mosleh, Lecturer, Al-Azhar Faculty of Dentistary for girls

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Nafesa Mostafa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No