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Completed

NCT Number: NCT05721586

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

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.

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Key information

Conditions

White Spot Lesion

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2023
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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