Clinical trial
The Desensitising Effect of Nanosilver Fluoride Compared to Low-Level Laser Therapy in Molar-Incisor Hypomineralisation: A Randomised Controlled Clinical Trial
Name
0797-11/2023
Description
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.
Trial arms
Trial start
2024-04-01
Estimated PCD
2024-06-01
Trial end
2024-07-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Low-level laser therapy
Wavelength 980nm (SmartM, Lasotronix, Poland)
Arms:
Low-level laser therapy
Nanosilver fluoride
Optimized synthesis of Nanosilver Fluoride
Arms:
Nanosilver fluoride
Size
120
Primary endpoint
Desensitising effect in hypersensitive MIH molars
1 month
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-06-04
1 organization
1 product
2 indications
Organization
Alexandria UniversityProduct
Nanosilver fluorideIndication
Molar-Incisor HypomineralizationIndication
Hypersensitivity