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Not yet recruitingNCT07753070Updated Aug 7, 2026

Aesthetic Masking and Resin Infiltration Time in MIH-affected Incisors

An interventional study of macroabrasion followed by oxidative pretreatment and macroabrasion alone in Molar Incisor Hypomineralization, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
8 Years to 13 Years
Sex
All
01

Study summary

Background: Resin infiltration often shows unpredictable outcomes in teeth affected by molar incisor hypomineralisation (MIH) due to variable enamel porosities, hypermineralised surface layers, and elevated protein content. Different pretreatment modalities alongside modified resin infiltration protocols have been suggested to enhance aesthetic masking and the required resin infiltration time.

Aim: To compare the effectiveness of transillumination-guided 5.25% NaOCl pretreatment following macroabrasion, with macroabrasion alone, each with 10-second hydrochloric acid (HCl) etching intervals, on aesthetic masking and resin infiltration time required in MIH-affected incisors.

02

Conditions studied

  • Molar Incisor Hypomineralization
03

In context

Molar Hypomineralization

133 studies on the registry are indexed under Molar Hypomineralization; 46 are open to participants now.

This study's planned enrollment of 100 is above the median of 53 across 104 interventional studies indexed under Molar Hypomineralization.

Browse Molar Hypomineralization studies →

Lead sponsor

Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy children with MIH-related mild white creamy opacities on permanent incisors, code 1 according to the European Academy of Paediatric Dentistry (EAPD) criteria.
  • Clinically detectable isolated lesions (whether homogeneous or heterogeneous on the incisal and middle thirds of the buccal surface of the selected teeth.
  • Patients with score 3 (positive) or score 4 (definitely positive) according to Frankl behavioral rating scale
  • Parents or legal guardians accepting to sign a written consent and join the study

Exclusion criteria

Exclusion Criteria:

  • MIH-affected permanent incisors with post-eruptive enamel breakdown, cavitated lesions, restorations, or previously treated with surface layer removal or remineralising agents in the previous six months.
  • Children with an allergy history
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Test Group

    Other: macroabrasion followed by oxidative pretreatment

  • Active comparator
    Control Group

    Other: macroabrasion alone

Interventions

  • Othermacroabrasion followed by oxidative pretreatment

    Fine-grit aluminum oxide finishing stone under water coolant, using a high-speed handpiece to remove the superficial enamel layer, then 5.25% sodium hypochlorite will be applied to the labial lesion surface and agitated with a microbrush for one minute, then rinsed for 20 seconds.

  • Othermacroabrasion alone

    Fine-grit aluminum oxide finishing stone under water coolant, using a high-speed handpiece to remove the superficial enamel layer,

06

What researchers measure

Primary outcomes

  1. change in aesthetic masking effectiveness

    Transillumination images (T0, Tx, Tmax) will be imported into ImageJ (National Institutes of Health, MD, USA), resized, and superimposed to align the labial surfaces. The labial surface and opacity will be manually outlined to measure their respective surface areas. The opacity area ratio will then be calculated as: R = (AO × 100) / AL, where AO is the opacity area and AL is the total labial surface area

    Time frame: up to 6 months

Secondary outcomes

  1. change in color stability

    2\. Color stability will be calculated based on the changes in the CIE L\*a\*b\* values over time. The color difference (ΔE) between timepoints will be obtained using the following formula: ΔE=√\[(ΔL)2 + (Δa)2 + (Δb)2\].

    Time frame: up to 6 months

  2. Changes in the patient-reported SCASS scores

    The Schiff Cold Air Sensitivity Scale (SCASS) was used to assess patient-reported dentin hypersensitivity following an air stimulus. The scale ranges from 0 to 3, where 0 indicates no response to the stimulus, 1 indicates a response without requesting discontinuation, 2 indicates a response accompanied by a request to stop the stimulus or withdrawal from it, and 3 indicates a painful response with an immediate request to discontinue the stimulus and/or marked painful behavior. Higher SCASS scores indicate greater dentin hypersensitivity.

    Time frame: up to 6 months

  3. change in patient satisfaction

    5-point Likert scale for the patients' satisfaction. higher socres mean more satisfaction

    Time frame: up to 6 months

07

Study locations

1 site
  • Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, Alexandria University, Egypt
    Alexandria, Egypt
    • Alexandria University · Contact
    • Mariam AbdulAziz, BDS · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07753070
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Aug 10, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Aug 7, 2026

Study contacts

Maryam AbdulAziz
Contact
coolmaryomi96@gmail.com
01033254672

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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