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

Not Applicable

Recruiting

• Conditions: Molar Incisor Hypomineralisation

• Registration Number: NCT07162077
• Lead Sponsor: Tishreen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-25
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-09-07
• Last Update Submitted: 2025-09-07
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Primary Completion: 2026-09
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Masking efficacy	The masking efficacy will be analyzed on day 1 and (7 - 10) days after day 1	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.

Secondary Outcome Measures

Name	Time	Method
The satisfaction of the parents	On day 1 and (7-10) days after	Likert scale

Trial Locations

Locations (1)

TishreenU; 🇸🇾 Latakia, Syria