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NCT Number: NCT06348849

The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation

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.

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Key information

Conditions

Molar Incisor Hypomineralization Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Hypersensitivity Immune System Diseases Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21521, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-Level Laser Therapy

Device

Wavelength 980nm (SmartM, Lasotronix, Poland)

Nanosilver fluoride

Drug

Optimized synthesis of Nanosilver Fluoride

Primary outcomes

  1. Desensitising effect in hypersensitive MIH molars

    Time frame: 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 outcomes

  1. Change in the plaque index scores

    Time frame: 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.

  2. Change in children's frequency of toothbrushing

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2024
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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