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

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Peptide
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Dentistary - Al-Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Negative control group (A1)

Treatment group (A2)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 12, 2022
Last Updated
January 4, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05667545
Brief Title
Evaluation of the Effect of Self-Assembling Peptide P11-4
Official Title
Evaluation of the Remineralizing Effect of Self-assembling Peptide P11-4 on Caries Affected Dentin.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative control group (A1)
Arm Type
Active Comparator
Arm Description
A1: cavities will be sealed directly by restorative material (conventional glass ionomer) without any treatment.
Arm Title
Treatment group (A2)
Arm Type
Active Comparator
Arm Description
A2: cavities will be treated by Self-Assembling peptide P11-4 then sealed by conventional glass ionomer.
Intervention Type
Drug
Intervention Name(s)
Peptide
Other Intervention Name(s)
peptide P11-4
Intervention Description
it is about synthetic protein acting on tooth structure help information apatite crystals
Primary Outcome Measure Information:
Title
Remineralization
Description
Assessment of the remineralizing effect of self-assembling peptide P11-4 on affected-caries dentin. Remineralization will be assessed by radiodensity using digital radiography
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa Mosleh, Lecturer
Organizational Affiliation
Al-Azhar Faculty of Dentistary for girls
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistary - Al-Azhar University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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