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

Tishreen University

Status: Enrolling

Conditions: Molar Incisor Hypomineralisation

Treatments: Procedure: Sodium hypochlorite 5.25%; Procedure: ICON resin infiltration Material group in vivo

Study type: Interventional

Funder types: Other

Identifiers

NCT07162077

TishreenU- Pediatric Dentistry

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Sodium hypochlorite & ICON

Experimental group

Description:

Resin infitration ( ICON (DMG, Hamburg, Germany)) and sodium hypochlorite 5.25%

Treatment:

Procedure: Sodium hypochlorite 5.25%

ICON

Active Comparator group

Description:

Resin infiltration ( ICON (DMG, Hamburg, Germany))

Treatment:

Procedure: ICON resin infiltration Material group in vivo