An interventional study of Sodium hypochlorite 5.25% and ICON resin infiltration Material group in vivo in Molar Incisor Hypomineralisation, sponsored by Latakia University. Completed at 1 site in Syria. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Latakia University · Not applicable, Interventional, and Treatment
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.
133 studies on the registry are indexed under Molar Hypomineralization; 46 are open to participants now.
This study's enrollment of 15 is below the median of 53 across 104 interventional studies indexed under Molar Hypomineralization.
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Exclusion Criteria:
Resin infitration ( ICON (DMG, Hamburg, Germany)) and sodium hypochlorite 5.25%
Procedure: Sodium hypochlorite 5.25%
Resin infiltration ( ICON (DMG, Hamburg, Germany))
Procedure: ICON resin infiltration Material group in vivo
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
Masking efficacy
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.
Time frame: The masking efficacy will be analyzed on day 1 and (7 - 10) days after day 1
The satisfaction of the parents
Likert scale
Time frame: On day 1 and (7-10) days after
Ran from Aug 2025 to primary completion in Sep 2026, 12 months.
Of 62 non-industry interventional studies with no phase under Molar Hypomineralization, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's 12 months is below that.
Counting every sponsor, half of 62 studies reached it within 14 months; a quarter within 8 and three quarters within 25.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Latakia University