RecruitingNot Applicable

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

Syria24 participantsStarted 2025-08-25

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Masking efficacy

Timeframe: The masking efficacy will be analyzed on day 1 and (7 - 10) days after day 1

Trial details

NCT IDNCT07162077

SponsorTishreen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

NRaslan

+963999140762 raslan.nabih@tishreen.edu.sy

View on ClinicalTrials.gov More Molar Incisor Hypomineralisation trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.