A Phase 2/3 interventional study of Low-level laser therapy and Nanosilver fluoride in Molar Incisor Hypomineralization and Hypersensitivity, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 7 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Alexandria University · Phase 2/3, Interventional, and Treatment
The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy.
121 studies on the registry are indexed under Molar Hypomineralization; 41 are open to participants now.
This study's enrollment of 120 is above the median of 52 across 94 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →Alexandria University is the lead sponsor of 570 studies on the registry; 126 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
These hypersensitive molars with MIH will receive low-level laser therapy.
Device: Low-level laser therapy
These hypersensitive molars with MIH will receive nanosilver fluoride treatment.
Drug: Nanosilver fluoride
Wavelength 980nm (SmartM, Lasotronix, Poland)
Optimized synthesis of Nanosilver Fluoride
Desensitising effect in hypersensitive MIH molars
This will be performed using Schiff Cold Air Sensitivity Scale (SCASS). The SCASS will be used to assess subject response to this stimulus (0=no response to the stimulus; 1=no response to the stimulus, patient considers stimulus to be painful; 2= response to stimulus, patient moves from the stimulus; 3= response to the stimulus, patient moves from the stimulus and requests immediate discontinuation of the stimulus)
Time frame: 1 month
Change in the plaque index scores
This will be assessed using the modified plaque index (PlI) of Silness and Löe. Each tooth will be scored from 0 (lowest) to 3 (highest) according to the amount of plaque accumulation. The total score will be determined by calculating the average score of the examined teeth.
Time frame: 1 month
Change in children's frequency of toothbrushing
The frequency of toothbrushing will be assessed using a question adapted from the World Health Organization (WHO) questionnaire- child version. The parent will be asked about the number of times his/her child brushes their teeth (never - several times a month - once a week - several times a week - once daily - twice or more daily)
Time frame: 1 month
Plan to share: Undecided
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Alexandria University