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Assessing the Effects of Resin Infiltration and Resin Modified Glass Ionomer on the Color Changes of White Spot Lesions in a Clinical and Laboratory Setting

NCT06696105 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-21

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the efficacy of "Icon® resin infiltration" and "VanishTM XT varnish" in restoring the appearance of white spot lesions WSLs in healthy children affected with anterior white spot lesions. The main questions it aims to answer are:

1- Are Icon resin infiltration (RI) and Vanish™ XT varnish comparable in restoring esthetics of white spot lesions? Researchers will compare Resin infiltration to vanish xt varnish to see if they are effective in masking white spot lesions

Participants will:

* Have their white spot lesions treated in the dental clinic by the intervention methods
* Visit the clinic after 1 month, 3 months and 6 months to assess the restorations objectively and subjectively

Conditions

  • White Spot Lesions
  • White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
  • Enamel Hypomineralization

Interventions

DRUG

Resin infiltration

"Icon® resin infiltration (DMG America, Englewood, NJ, US)" technique utilizes light-cured hydrophilic and low viscosity resins that can permeate WSL subsurface micropores. Resin modified glass ionomer cement includes Fluoroaluminosilicate glass, which facilitates the interaction of fluoride with the enamel surface resulting in an instant release . Concurrently, the predominant glass matrix serves as source of fluoride for the purpose of continuous release, hypothesized to facilitate remineralization.

DRUG

Vanish XT varnish (resin modified glass ionomer restoration)

Resin modified glass ionomer cement includes Fluoroaluminosilicate glass, which facilitates the interaction of fluoride with the enamel surface resulting in an instant release. Concurrently, the predominant glass matrix serves as source of fluoride for the purpose of continuous release, hypothesized to facilitate remineralization.

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Principal Investigators

  • Omar El-Meligy, MSc,Ph.D. · King Abdulaziz University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2025-06-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06696105 on ClinicalTrials.gov