Actively Recruiting

Age: 6Years - 10Years
All Genders
ID05806398

Use of a Glass Ionomer Sealant in First Permanent Molars Affected by Molar Incisor Hypomineralization

Led by IRCCS Burlo Garofolo · Updated on 2024-06-14

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Molar Incisor Hypomineralization (MIH) is a common developmental defect of the dental enamel affecting one or more permanent molars, usually the first permanent molars, and sometimes permanent incisors. The enamel in MIH is porous and has reduced mechanical strength, leading to problems like altered appearance, increased risk of plaque, cavities, breakdown of enamel, sensitivity, and difficulty in numbing affected teeth. This condition varies in severity and is challenging to manage, especially in molars which face higher chewing forces and are harder to clean. The study aims to assess the survival rate of glass ionomer sealants used as a preventive treatment on MIH-affected first permanent molars over 12 months. Sealants are applied to protect the teeth from cavities, with resin-based sealants preferred when the tooth is fully erupted and dry, while glass ionomer sealants are used temporarily when moisture control is difficult or the tooth is sensitive. This observational study will monitor how well glass ionomer sealants last on these teeth. Participants aged 6 to 10 years with MIH-affected molars showing lesions on the chewing surface will be followed for one year. Researchers will examine the teeth clinically to check the sealant's retention and durability. The study focuses on the sealant survival rate at 12 months, aiming to gather more evidence on the best preventive treatments for MIH-affected molars. Consent from parents or guardians is required, and participant cooperation is important for ongoing monitoring.

CONDITIONS

Brief Title

Use of a Glass Ionomer Sealant in Molar Incisor Hypomineralization

Who Can Participate

Age: 6Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 10 years
  • Presence of first permanent molars affected by MIH with lesions on the chewing surface
  • Good general health
  • Sufficient cooperation during dental visits
  • Signed informed consent from parent or legal guardian
Not Eligible

You will not qualify if you...

  • Presence of fluorosis, amelogenesis imperfecta, white spots, or other enamel defects aside from MIH
  • First permanent molars with sealed or restored chewing surfaces
  • Cavitated occlusal caries on first permanent molars (ICDAS score 3 or higher)
  • Severe post-eruptive breakdown involving dentin on first permanent molars
  • Children with orthodontic devices covering first permanent molars

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants who undergo routine care are observed to assess the survival rate of the glass ionomer sealant in molar incisor hypomineralization affected molars.

Periodic visits during the 12-month follow-up

Trial Site Locations

Total: 1 location

1

IRCCS Burlo Garofolo

Trieste, Italy, 34137

Actively Recruiting

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Research Team

M

Milena Cadenaro, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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