The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation

Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06348849
• Other study ID #: 0797-11/2023
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2024
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Hypersensitivity
• Molar Incisor Hypomineralization

Intervention

Device:
• Low-level laser therapy
Wavelength 980nm (SmartM, Lasotronix, Poland)

Drug:
• Nanosilver fluoride
Optimized synthesis of Nanosilver Fluoride

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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