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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06348849
Other study ID # 0797-11/2023
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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