The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation

NCT06348849 | Completed Phase 2

• 1 other identifier: 0797-11/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization; Hypersensitivity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  1 month

Secondary Outcomes (2)

• Change in the plaque index scores

  1 month

• Change in children's frequency of toothbrushing

  1 month

Study Arms (2)

Low-level laser therapy

ACTIVE COMPARATOR

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

Device: Low-level laser therapy

Nanosilver fluoride

EXPERIMENTAL

These hypersensitive molars with MIH will receive nanosilver fluoride treatment.

Drug: Nanosilver fluoride

Interventions

Low-level laser therapy DEVICE

Wavelength 980nm (SmartM, Lasotronix, Poland)

Low-level laser therapy

Nanosilver fluoride DRUG

Optimized synthesis of Nanosilver Fluoride

Nanosilver fluoride

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21521, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40716831 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization; Hypersensitivity

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immune System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

EG (1)