Aesthetic Masking and Resin Infiltration Time in MIH-affected Incisors
ConditionMolar Incisor Hypomineralization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-13
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
macroabrasion followed by oxidative pretreatment
Other interventionFine-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 interventionFine-grit aluminum oxide finishing stone under water coolant, using a high-speed handpiece to remove the superficial enamel layer,
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
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 monthsSecondary 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 months2
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 months3
change in patient satisfaction
5-point Likert scale for the patients' satisfaction. higher socres mean more satisfaction
Time frame
up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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