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

White Spot Lesion Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721586
• Other study ID #: P11-4_2020
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: February 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• White Spot Lesion

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in DIAGNOdent readings	The measurements with the DIAGNOdent device that provides numerical values from 0 to 99	Baseline, 3 months, and 6 months
Secondary	Change in ICDAS II scores	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
Secondary	Change in Nyvad scores	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