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NCT Number: NCT07753070

Aesthetic Masking and Resin Infiltration Time in MIH-affected Incisors

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.

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Key information

Conditions

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

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location contact

Alexandria University

CONTACT

Mariam AbdulAziz, BDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

macroabrasion followed by oxidative pretreatment

Other

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.

macroabrasion alone

Other

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

Primary outcomes

  1. change in aesthetic masking effectiveness

    Time frame: up to 6 months

    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

Secondary outcomes

  1. change in color stability

    Time frame: up to 6 months

    • 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].

  2. Changes in the patient-reported SCASS scores

    Time frame: up to 6 months

    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.

  3. change in patient satisfaction

    Time frame: up to 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Maryam AbdulAziz

CONTACT

[email protected]

01033254672

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effectiveness of Transillumination-Guided Surface Pretreatment on Aesthetic Masking and Resin Infiltration Time in MIH-affected Incisors (A Randomised Clinical Trial)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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