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

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.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity; Molar Incisor Hypomineralization
• Intervention / Treatment: Device: Low-level laser therapy; Drug: Nanosilver fluoride

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21521
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-level laser therapy; These hypersensitive molars with MIH will receive low-level laser therapy.	Device: Low-level laser therapy; Wavelength 980nm (SmartM, Lasotronix, Poland)
Experimental: Nanosilver fluoride; These hypersensitive molars with MIH will receive nanosilver fluoride treatment.	Drug: Nanosilver fluoride; Optimized synthesis of Nanosilver Fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	1 month

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; LLLT; Clinical trial; Low-level laser therapy; Nanosilver fluoride; Desensitising; Molar-incisor hypomineralisation; First permanent molars; Nanosilver
• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Immune System Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Molar Hypomineralization; Hypersensitivity; Dental Enamel Hypoplasia; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 0797-11/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No