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

NCT ID: NCT05667545

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-10-30

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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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),
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Negative control group (A1)

A1: cavities will be sealed directly by restorative material (conventional glass ionomer) without any treatment.

Group Type ACTIVE_COMPARATOR

Peptide

Intervention Type DRUG

it is about synthetic protein acting on tooth structure help information apatite crystals

Treatment group (A2)

A2: cavities will be treated by Self-Assembling peptide P11-4 then sealed by conventional glass ionomer.

Group Type ACTIVE_COMPARATOR

Peptide

Intervention Type DRUG

it is about synthetic protein acting on tooth structure help information apatite crystals

Interventions

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Peptide

it is about synthetic protein acting on tooth structure help information apatite crystals

Intervention Type DRUG

Other Intervention Names

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peptide P11-4

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Egymedicalpedia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Asmaa Mosleh, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar Faculty of Dentistary for girls

Locations

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Faculty of Dentistary - Al-Azhar University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Nafesa Mostafa

Identifier Type: -

Identifier Source: org_study_id

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