Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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