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

February 1, 2023 updated by: Hams Hamed Abdelrahman

Effectiveness of Self-assembling Peptide (p11-4) in Conjunction With Fluoride Varnish in the Management of White Spot Lesions in Primary Teeth (Randomized Controlled Clinical Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CURODONTTM REPAIR: + Fluoride varnish (DURAFLOR)
Other: 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
ACTIVE_COMPARATOR: Fluoride Varnish (DURAFLOR) only
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in DIAGNOdent readings
Time Frame: Baseline, 3 months, and 6 months
The measurements with the DIAGNOdent device that provides numerical values from 0 to 99
Baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ICDAS II scores
Time Frame: Baseline, 3 months, and 6 months

Code 0 Sound tooth surface:

Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry.

Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow.

Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown.

Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin. After treatment, the evaluation will be performed as follows.
Baseline, 3 months, and 6 months
Change in Nyvad scores
Time Frame: Baseline, 3 months, and 6 months

Code 0: Sound - Normal enamel

Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque

Code 2: Active caries (surface discontinuity)

Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye.

Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black.

Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2020

Primary Completion (ACTUAL)

May 30, 2021

Study Completion (ACTUAL)

May 30, 2021

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P11-4_2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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