Etch‑bleach‑seal treatment with Icon® for opacities from molar‑incisor hypomineralisation
The Effectiveness of Sodium Hypochlorite Application in Managing Opacities of Molar-incisor Hypomineralization on Incisors Using Resin Infiltration
This test will see if adding sodium hypochlorite to Icon® resin infiltration improves the look of yellow/brown opacities on permanent front teeth in people with MIH.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Sex | All |
| Sponsor | Tishreen University Academic / other |
| Locations | 1 site (Latakia) |
| Trial ID | NCT07162077 on ClinicalTrials.gov |
What this trial studies
The trial will randomly allocate 24 MIH‑affected incisors, diagnosed by EAPD criteria, to receive Icon® resin infiltration with or without sodium hypochlorite irrigation. In the test arm, 5.25% sodium hypochlorite is applied with cotton wads before treatment and as an irrigation step between etching cycles, followed by Icon‑Infiltrant; the control arm follows the same etch/dry/infiltrant protocol without sodium hypochlorite. Outcomes include objective aesthetic masking of the opacities and parent satisfaction with the cosmetic result. The protocol selects isolated lesions on the incisal/middle buccal thirds and excludes teeth with prior bleaching, restorations, micro‑abrasion, remineralization, fluorosis, amelogenesis imperfecta, or tetracycline staining.
Who should consider this trial
Good fit: People who have MIH with isolated yellow or brown opacities on the incisal or middle third of permanent incisors (with molar involvement per MIH diagnostic criteria) and no prior bleaching, micro‑abrasion, restorations, or remineralization on those teeth.
Not a fit: Patients with prior composite restorations, external bleaching, micro‑abrasion, remineralization therapies, orthodontic white‑spot lesions, dental fluorosis, amelogenesis imperfecta, or tetracycline staining are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the procedure could provide a minimally invasive way to better mask MIH‑related enamel discoloration on anterior teeth.
How similar studies have performed: Resin infiltration (Icon®) has shown promise for masking enamel opacities in prior reports, but using sodium hypochlorite as an intraoperative adjunct for MIH masking is less well documented.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Latakia
- TishreenU — Latakia, Syria (Recruiting)
Study contacts
- Study coordinator: NRaslan
- Email: raslan.nabih@tishreen.edu.sy
- Phone: +963999140762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.