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Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride

NCT ID: NCT05094492

Last Updated: 2021-10-26

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-30

Study Completion Date

2022-06-30

Brief Summary

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Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.

Detailed Description

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This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).

Conditions

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Caries; Initial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Self assembling peptide P11-4 with fluoride

P11-4 forms a 3D matrix within subsurface of incipient carious lesions , allowing formation of new hydroxyapatite crystal facilitating guided regeneration of enamel lesions. Combination with fluoride will have a synergistic effect on remineralization potential

Group Type EXPERIMENTAL

Curodont Repair Fluoride Plus

Intervention Type COMBINATION_PRODUCT

P11-4 self assembling peptide combined with fluoride

Fluoride varnish

Gold standard agent for remineralization of incipient carious lesions.

Group Type ACTIVE_COMPARATOR

Bifluorid 10 fluoride varnish

Intervention Type OTHER

5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)

Interventions

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Curodont Repair Fluoride Plus

P11-4 self assembling peptide combined with fluoride

Intervention Type COMBINATION_PRODUCT

Bifluorid 10 fluoride varnish

5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Active carious white spot lesions.
* Patient compliance.
* Controlled oral hygiene condition.

Exclusion Criteria

* Participant in another trial.
* Non carious lesions.
* Systemic diseases or concomitant medication affecting salivary flow.
* Cavitation of carious lesions.
* Parafunctional habits.
* Pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Omar Osama Shaalan

Lecturer, Conservative Dentistry Department, Faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar O Shaalan, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Locations

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Faculty of Dentistry, Cairo University

Cairo, El Manial, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Omar O Shaalan, PhD

Role: CONTACT

Phone: 00201122665661

Email: [email protected]

Facility Contacts

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Omar O Shaalan, Phd

Role: primary

Other Identifiers

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p11-4

Identifier Type: -

Identifier Source: org_study_id