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The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation

The Desensitising Effect of Nanosilver Fluoride Compared to Low-Level Laser Therapy in Molar-Incisor Hypomineralisation: A Randomised Controlled Clinical Trial

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06348849
Enrollment
120
Registered
2024-04-05
Start date
2024-04-01
Completion date
2024-08-01
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity, Molar Incisor Hypomineralization

Keywords

Nanosilver fluoride, Low-level laser therapy, Desensitising, Molar-incisor hypomineralisation, First permanent molars, Pediatric, Clinical trial, Nanosilver, LLLT

Brief summary

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.

Interventions

DEVICELow-level laser therapy

Wavelength 980nm (SmartM, Lasotronix, Poland)

Optimized synthesis of Nanosilver Fluoride

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* The presence of at least one hypersensitive first permanent molar in MIH patient (using the Schiff Cold Air Sensitivity Scale (SCASS)). * Completion of an informed consent to participate in the study.

Exclusion criteria

* Hypomineralised molars resulting from other medical conditions, such as enamel malformations associated with syndromes, dental fluorosis, enamel hypoplasia, amelogenesis imperfecta, and dental caries. * The presence of active tooth decay or defective restorations in the tooth under examination which can confound the aetiology of hypersensitivity with pulpitis. * The presence of pulpal symptoms. * Having undergone any professional desensitising treatment in the previous 6 months. * Having used a desensitising paste other than habitual toothpaste in the previous 3 months. * Use of anti-inflammatory drugs or analgesics at the time of recruitment. * Allergy or sensitivity to silver or any of the materials included in the study.

Design outcomes

Primary

MeasureTime frameDescription
Desensitising effect in hypersensitive MIH molars1 monthThis 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)

Secondary

MeasureTime frameDescription
Change in the plaque index scores1 monthThis 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.
Change in children's frequency of toothbrushing1 monthThe 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026