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

NCT05667545 | Completed Phase 1 DMC

• 1 other identifier: Nafesa Mostafa
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Negative control group (A1)

ACTIVE COMPARATOR

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

Drug: Peptide

Treatment group (A2)

ACTIVE COMPARATOR

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

Drug: Peptide

Interventions

Peptide DRUG

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

Also known as: peptide P11-4

Negative control group (A1); Treatment group (A2)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Faculty of Dentistary - Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Peptides; P11-4 peptide

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Asmaa Mosleh, Lecturer

  Al-Azhar Faculty of Dentistary for girls

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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),

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 28, 2022
• Study Start: July 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 30, 2021
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

EG (1)