Self-assembling Peptide With Sodium Fluoride in Treating White Spot Lesionss in Primary Teeth

NCT ID: NCT05721586

Last Updated: 2023-02-10

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

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-05-30

Brief Summary

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Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimally invasive therapy using Self-Assembling Peptide P11-4 (CURODONTTM REPAIR) which enhances remineralization of white spot lesions (WSLs). The study aimed to assess clinically the effect of Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR) versus a 5% fluoride varnish (DURAFLOR) on remineralization of enamel White Spot Lesions in primary teeth.

Detailed Description

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Conditions

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White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CURODONTTM REPAIR: + Fluoride varnish (DURAFLOR)

Group Type EXPERIMENTAL

Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR

Intervention Type OTHER

The WSL was Acid etched with phosphoric acid gel 35-37% for 20 seconds, the tooth surface was rinsed with water and then dried afterwards application of CURODONTTM REPAIR

Fluoride Varnish (DURAFLOR) only

Group Type ACTIVE_COMPARATOR

Fluoride varnish (DURAFLOR

Intervention Type OTHER

A very thin coat of the DURAFLOR varnish was applied by a thin brush which was then allowed to dry for 10 seconds. The varnish hardens on contact with saliva or moisture

Interventions

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Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR

The WSL was Acid etched with phosphoric acid gel 35-37% for 20 seconds, the tooth surface was rinsed with water and then dried afterwards application of CURODONTTM REPAIR

Intervention Type OTHER

Fluoride varnish (DURAFLOR

A very thin coat of the DURAFLOR varnish was applied by a thin brush which was then allowed to dry for 10 seconds. The varnish hardens on contact with saliva or moisture

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* children with high caries risk with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1, 2 or 3

Exclusion Criteria

* Children with systemic diseases
* Teeth with cavitated lesion involving dentin and enamel defects
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P11-4_2020

Identifier Type: -

Identifier Source: org_study_id

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