The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation

Phase 2

Completed

• Conditions: Molar Incisor Hypomineralization; Hypersensitivity
• Interventions: Drug: Nanosilver fluoride; Device: Low-level laser therapy

• Registration Number: NCT06348849
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-31
• Study First Submitted QC: 2024-03-31
• Study Start: 2024-04-01
• Study First Posted: 2024-04-05
• Primary Completion: 2024-06-01
• Study Completion: 2024-08-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanosilver fluoride	Nanosilver fluoride	These hypersensitive molars with MIH will receive nanosilver fluoride treatment.
Low-level laser therapy	Low-level laser therapy	These hypersensitive molars with MIH will receive low-level laser therapy.

Primary Outcome Measures

Name	Time	Method
Desensitising effect in hypersensitive MIH molars	1 month	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)

Secondary Outcome Measures

Name	Time	Method
Change in the plaque index scores	1 month	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.
Change in children's frequency of toothbrushing	1 month	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)

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt