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

NCT ID: NCT07162077

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Molar Incisor Hypomineralisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

teeth will be randomized in two groups (test group and control group)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sodium hypochlorite & ICON

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

Group Type EXPERIMENTAL

Sodium hypochlorite 5.25%

Intervention Type PROCEDURE

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.

ICON

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

Group Type ACTIVE_COMPARATOR

ICON resin infiltration Material group in vivo

Intervention Type PROCEDURE

In control group, the investigators will be applied the same protocol of test group but without using sodium hypochlorite

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tishreen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TishreenU

Latakia, , Syria

Site Status RECRUITING

Countries

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Syria

Central Contacts

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NRaslan

Role: CONTACT

+963999140762

Facility Contacts

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NRaslan

Role: primary

+963999140762

Other Identifiers

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TishreenU- Pediatric Dentistry

Identifier Type: -

Identifier Source: org_study_id

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