The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation

NCT ID: NCT06348849

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Molar Incisor Hypomineralization Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low-level laser therapy

These hypersensitive molars with MIH will receive low-level laser therapy.

Group Type ACTIVE_COMPARATOR

Low-level laser therapy

Intervention Type DEVICE

Wavelength 980nm (SmartM, Lasotronix, Poland)

Nanosilver fluoride

These hypersensitive molars with MIH will receive nanosilver fluoride treatment.

Group Type EXPERIMENTAL

Nanosilver fluoride

Intervention Type DRUG

Optimized synthesis of Nanosilver Fluoride

Interventions

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Low-level laser therapy

Wavelength 980nm (SmartM, Lasotronix, Poland)

Intervention Type DEVICE

Nanosilver fluoride

Optimized synthesis of Nanosilver Fluoride

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Nouran Nabil

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Nabil N, Sharaf AA, Essawy MM, Soliman RS. The Desensitizing Effect of Nanosilver Fluoride Compared to Photobiomodulation Therapy in Molar-Incisor Hypomineralization: A Randomized Clinical Trial. J Evid Based Dent Pract. 2025 Sep;25(3):102139. doi: 10.1016/j.jebdp.2025.102139. Epub 2025 Mar 14.

Reference Type DERIVED
PMID: 40716831 (View on PubMed)

Other Identifiers

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0797-11/2023

Identifier Type: -

Identifier Source: org_study_id

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