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Recruiting NCT07162077

Etch-bleach-seal Technique in Managing Opacities Related MIH Using Icon®

No phase Interventional Molar Incisor Hypomineralisation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sodium hypochlorite 5.25%, ICON resin infiltration Material group in vivo.
Who it may be relevant to
Registry conditions: Molar Incisor Hypomineralisation. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Syria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effectiveness of Sodium Hypochlorite Application in Managing Opacities of Molar-incisor Hypomineralization on Incisors Using Resin Infiltration

Overview

Objectives: to compare aesthetic effectiveness of resin infiltration with/without using sodium hypochlorite in managing opacities of MIH on incisors, and to compare parent's satisfaction with results of both application protocols. Methods: Twenty-four teeth with yellow/ brown opacities of MIH, will be diagnosed according to EAPD diagnostic criteria, will be randomly allocated to test or control group. In the test group, the investigators will be applied sodium hypochlorite 5.25% by using cotton wad before treatment, then after the first and second etching cycles (application of the Icon-Etch (ICON® -Etch; DMG, Hamburg, Germany) and Icon-dry (ICON® -Dry; DMG, Hamburg, Germany) according to the manufacturer's recommendations) as irrigation step and following the third -Etch etching cycle Icon-infiltrant (ICON® -Infiltrant; DMG, Hamburg, Germany) will be applied . In control group, the investigators will be applied the same protocol of test group but without using sodium hypochlorite. The masking efficacy will be analyzed using the Lab System to calculate the color difference (ΔE) between the opacity and the adjacent enamel in Adobe Photoshop 2024. The infiltration proportion of opacity will be measured using Image J software and the infiltrated area will be expressed as a percentage. The satisfaction of the parents with the results of both application protocols will be compared using Likert scale.

Interventions

  • Procedure Sodium hypochlorite 5.25%
    In the test group, the investigators will be applied sodium hypochlorite 5.25% by using cotton wad on the opacity before treatment, then after the first and second etching cycles (application of the Icon-Etch (ICON® -Etch; DMG, Hamburg, Germany) and Icon-dry (ICON® -Dry; DMG, Hamburg, Germany) according to the manufacturer's recommendations) as irrigation step and following the third -Etch etching cycle Icon-infiltrant (ICON® -Infiltrant; DMG, Hamburg, Germany) will be applied.
  • Procedure ICON resin infiltration Material group in vivo
    In control group, the investigators will be applied the same protocol of test group but without using sodium hypochlorite

Primary outcome measures

  • Masking efficacy [Time frame: The masking efficacy will be analyzed on day 1 and (7 - 10) days after day 1]
Secondary outcome measures (1)
  • The satisfaction of the parents [Time frame: On day 1 and (7-10) days after]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with MIH-related opacities on the incisal and middle thirds of the buccal surface of their permanent incisors, ac- cording to EAPD diagnostic criteria of (MIH), only isolated lesions will be selected.

Exclusion criteria

  • Teeth with resin composite restorations, previously treated by exter- nal bleaching, micro-abrasion or re-mineralization(fluoride varnish or calcium-based products such asCPP-ACP) will be excluded.
  • Opacities present only on incisors without molar
  • WSLs caused by orthodomtic treatment
  • Teeth affected by dental fluorosis, Amelogenesis imperfecta and Tetracycline-pigmented teeth

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Syria · 1 center
  • TishreenU — Latakia

Identifiers

NCT: NCT07162077 · TishreenU- Pediatric Dentistry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗