An interventional study of ICON® resin infiltration and Opalustre® enamel microabrasion in Enamel Hypomineralization, Dental, sponsored by Shaimaa Abdelrahman. Not yet recruiting at 1 site in Egypt. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Shaimaa Abdelrahman · Not applicable, Interventional, and Treatment
The aim of the study is to determine the effectiveness of minimally invasive treatments in reducing the visible enamel opacities on permanent anterior teeth in children aged from seven to twelve years with hypomineralized lesions.
A secondary purpose is to evaluate patient satisfaction and the psychosocial impact of the treatment on the esthetic perception of the treated children.
The results of all the research papers about treating enamel discoloration caused by hypomineralization with the ICON system can be accepted as satisfactory. However, not all cases achieved the full aesthetic aim.
Microabrasion is an acid abrasive removal and not the dissolution of enamel stain. It is as a treatment modality for enamel opacities like brown, orange, or yellow enamel spots; and fluorotic white streaks. Esthetic results could be reached when microabrasion followed by a remineralizing agent such as C PP-ACFP.
Null hypothesis, there is no difference between microabrasion followed by a remineralizing agent and resin infiltration treatment regarding clinical effectiveness \& patient satisfaction.
Outcomes:
Primary outcome Color enhancement using Clinical photographs (Bhandari, et al., 2019). Secondary outcomes
Follow up after 1 day for adverse and undesirable side effects, 1week \& 6 months.
Randomization:
The participants will be randomly assigned to one of the three experimental groups the interventions and control groups using simple randomization with a 1:1 allocation ratio.
Masking/blinding:
Neither the operator nor the patients could be blinded due to the nature of the study but the outcome assessor and statistician will be blinded.
20 studies on the registry are indexed under Dental Enamel Hypomineralization; 6 are open to participants now.
This study's planned enrollment of 69 is above the median of 45 across 15 interventional studies indexed under Dental Enamel Hypomineralization.
Browse Dental Enamel Hypomineralization studies →This is the only study on the registry with Shaimaa Abdelrahman as lead sponsor.
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▪ Participants free from any systemic disease aged from 7 years to 12 years
Exclusion Criteria:
▪ Dental caries and filling,
Resin infiltration treatment (Icon®) for Hypomineralized anterior permanent teeth in children
Other: ICON® resin infiltration
Opalustre® Enamel Microabrasion Slurry
Other: Opalustre® enamel microabrasion
Antivet® enamel micro-abrasion
Other: Antivet® enamel micro-abrasion
* Applying a 15% hydrochloric acid gel (ICON-Etch; DMG; Hamburg, Germany®) for 120 s using the Icon® etch syringe included in the set, * followed by a thorough washing of the etchant for 30 s. and Dring the tooth using an air spray, * Once the enamel surface appeared chalky, Ethanol lesion desiccation (ICON-Dry; DMG®) will be performed for 30 s, * followed by drying using an air spray. * Using the Icon® infiltrant syringe Infiltration with a sufficient amount resin (ICON-Infiltrate; DMG®) of the lesion surface by massaging the tip of the syringe on the lesion in circular movements for 3 min. * Before drying, clean the remaining material and excess removal by Gauze or cotton swab and dental floss. * Light curing for 40 s with a light-cure device, * Then another round of infiltration will take place * One minute was provided for the material to infiltrate the pores, after which it was polymerized for 40 s.
* Isolation is extremely important because of the hydrochloric acid. Patients and clinician should both wear protective eyewear. * Isolate teeth to be treated and one tooth posterior on each side using rubber dam. * For additional protection, apply a bead of rubber dam sealer or light-cured resin barrier at the gingival margin beneath the dam. NOTE: For hypo-mineralization greater than 0.1-0.3mm use a fine-grit water-cooled tapered diamond bur, lightly sweep over the stained area for 5-10 seconds prior to applying Opalustre. * Apply approximately 1.0mm thick layer over the discolored area from Opalustre syringe with the White Mac tip. * Using a rubber prophy cup at a slow RPM (approximately 500 RPM), apply medium to heavy pressure for 60 seconds at a time. * Suction the paste from the teeth first, then rinse, evaluate and repeat as necessary. * Aesthetic improvement should be visualized on the wet surfaces. * After final rinse, remove rubber dam, and sealer from the teeth. Rinse
* The Antivet® abrasive solution (MDC DENTAL, Zapopan Jalisco, México) containing 21% hydrofluoric acid will be placed on the buccal surface with a cotton swab. * When the swab became pigmented, it will change to another clean swab with the abrasive solution. * The procedure would be repeated for 10 min. * When the process is finished, the excess solution will be cleaned using cotton, and calcium hydroxide as a neutralizing solution would be placed for 1 min with a micro brush. * In the end, rinsing with water for 30 s. * Apply MI varnish to the enamel.
Color enhancement measured by Clinical photographs
Clinical photographs will be taken with a digital camera macro lens, and flash. With the patient and digital camera at the same vertical plane and dental clinic illuminated evenly. The photographs will be taken in baseline, during the application time of the test or control. For standardizing the photographic conditions, the camera will be placed at the equidistance from the tooth. To prevent the change of refractive index by moisture, 30 s of drying of the lesion will be done.
Time frame: 6 months
Patient satisfaction measured by Visual analogue scale
The patient is asked to draw a line perpendicular to the VAS at their perceived pain-intensity level, no discomfort (score 0), mild discomfort (score 1-3), moderate (score 4-6) and very severe (7-9) or worst discomfort (score 10).
Time frame: 6 months
Reducing teeth hypersensitivity measured by The Schiff Cold Air Sensitivity Scale (SCASS)
It is a behavioral scale because it is based on observed behavior in response to a stimulus beyond a certain threshold. The dentist (or another assessor present) rates the response of the patient to the stimulus as 0 for no response to air stimulus, 1. for response to air stimulus but no request for discontinuation of the stimulus, 2. for response to air stimulus and requests discontinuation or moves from the stimulus\& 3. for response to air stimulus, considers stimulus to be painful, and requests discontinuation'
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Dental Enamel Hypomineralization →