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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07162077
Enrollment
24
Registered
2025-09-09
Start date
2025-08-25
Completion date
2026-10-31
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Incisor Hypomineralisation

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.

Interventions

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.

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

Sponsors

Tishreen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Masking efficacyThe masking efficacy will be analyzed on day 1 and (7 - 10) days after day 1The 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

MeasureTime frameDescription
The satisfaction of the parentsOn day 1 and (7-10) days afterLikert scale

Countries

Syria

Contacts

Primary ContactNRaslan
raslan.nabih@tishreen.edu.sy+963999140762

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026