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

NCT07162077 | Recruiting

• 1 other identifier: TishreenU- Pediatric Dentistry
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralisation

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• The satisfaction of the parents

  On day 1 and (7-10) days after

Study Arms (2)

Sodium hypochlorite & ICON

EXPERIMENTAL

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

Procedure: Sodium hypochlorite 5.25%

ICON

ACTIVE COMPARATOR

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

Procedure: ICON resin infiltration Material group in vivo

Interventions

Sodium hypochlorite 5.25% 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.

Sodium hypochlorite & ICON

ICON resin infiltration Material group in vivo PROCEDURE

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

ICON

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

TishreenU

Latakia, Syria

RECRUITING

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

NRaslan

CONTACT

+963999140762; raslan.nabih@tishreen.edu.sy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 9, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

SY (1)