Use of a Glass Ionomer Sealant in Molar Incisor Hypomineralization

Molar Incisor Hypomineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806398
• Other study ID #: RC 50/22
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: January 15, 2026

Study information

• Verified date: June 2024
• Source: IRCCS Burlo Garofolo
• Contact: Milena Cadenaro, MD
• Phone: +390403785111
• Email: milena.cadenaro[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Molar Incisor Hypomineralization (MIH) is a worldwide widespread qualitative developmental defect of the dental enamel with a multifactorial aetiology defined in 2001 as an "hypomineralization of systemic origin affecting one or more permanent molars, usually first permanent molars (FPMs), with or without the involvement of one or more affected permanent incisors". Clinically MIH lesions appear as demarcated opacities with a creamy-white to yellow-brown colour depending on the severity of the defect that is classified as mild or severe (levels of severity) according to the European Academy of Pediatric Dentistry (EAPD) severity criteria. The distribution of the lesions is asymmetrical and their severity varies from a patient to another and also within the mouth of the same patient. Due to its porous structure with an altered prism organization and an increased content of proteins, the hypomineralized enamel has reduced mechanical properties and a lower refractive index if compared to the sound enamel. MIH is associated to a large number of objective and subjective problems as an altered aesthetics, an increased risk of plaque accumulation, caries, post-eruptive breakdown (PEB), reduced retention rates of adhesive materials, hypersensitivity and difficulty in anesthetizing the affected teeth making its management a challenging condition. Among preventive measures, pit-and-fissure sealants are a valuable and effective treatment to prevent occlusal caries in FPMs when they are still intact. However, since their efficacy is closely related to the sealant retention, they have to be monitored over time. When the molar to be sealed is fully erupted and isolation is adequate, resin-based sealants are indicated while if the moisture control is inadequate and/or the tooth is hypersensitive and patient is not sufficiently cooperative, low-viscous glass ionomer cements (GICs) are suggested as a temporary measure until the eruption is completed and both symptoms and cooperation are improved. To date, the scientific knowledge regarding the use of different type of sealants in MIH affected molars is insufficient to draw exhaustive conclusions and further studies are needed to deepen the knowledge on this topic. The aim of this study is to assess, by clinical examination, the survival rate of a glass ionomer sealant in MIH affected FPMs at 12 months of follow-up.

Description:

Molar Incisor Hypomineralization (MIH) is a worldwide widespread qualitative developmental defect of the dental enamel with a multifactorial aetiology defined in 2001 as an "hypomineralization of systemic origin affecting one or more permanent molars, usually first permanent molars (FPMs), with or without the involvement of one or more affected permanent incisors". Clinically MIH lesions appear as demarcated opacities with a creamy-white to yellow-brown colour depending on the severity of the defect that is classified as mild or severe (levels of severity) according to the European Academy of Pediatric Dentistry (EAPD) severity criteria. The distribution of the lesions is asymmetrical and their severity varies from a patient to another and also within the mouth of the same patient. Due to its porous structure with an altered prism organization and an increased content of proteins, the hypomineralized enamel has reduced mechanical properties and a lower refractive index if compared to the sound enamel. MIH is associated to a large number of objective and subjective problems as an altered aesthetics, an increased risk of plaque accumulation, caries, post-eruptive breakdown (PEB), reduced retention rates of adhesive materials, hypersensitivity and difficulty in anesthetizing the affected teeth making its management a challenging condition.

Considering MIH histopathological features, while for incisors lesions are mainly an aesthetic issue, for molars they represent a real functional problem. Being FPMs subjected to higher masticatory loads than incisors and being located backward in the mouth, they have an increased risk of plaque accumulation, caries, PEB and are more difficult to be properly brushed especially if hypersensitive. An early diagnosis based on the EAPD judgement criteria and prevention are fundamental for acting with a minimally invasive therapeutic approach gaining the patient's cooperation and avoiding the most frequent related issues. Among preventive measures, pit-and-fissure sealants are a valuable and effective treatment to prevent occlusal caries in FPMs when they are still intact. However, since their efficacy is closely related to the sealant retention, they have to be monitored over time. When the molar to be sealed is fully erupted and isolation is adequate, resin-based sealants are indicated while if the moisture control is inadequate and/or the tooth is hypersensitive and patient is not sufficiently cooperative, low-viscous glass ionomer cements (GICs) are suggested as a temporary measure until the eruption is completed and both symptoms and cooperation are improved. About the use of resinous sealants in MIH molars, to date, literature data are limited and debated. About the use of glass ionomer (GI) sealants, several studies have been performed on sound molars but only a few on MIH molars. If the GI sealants' self-adhesive features, their high fluoride-release, hydrophilic properties and simple use are well known, their bond strength to the hypomineralized enamel and the survival rates on MIH molars are still controversial. To date, the scientific knowledge regarding the use of different type of sealants in MIH affected molars is insufficient to draw exhaustive conclusions and further studies are needed to deepen the knowledge on this topic. The aim of this study is to assess, by clinical examination, the survival rate of a glass ionomer sealant in MIH affected FPMs at 12 months of follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2026
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

1. FPMs of children aged between 6 and 10 years;

2. Erupted MIH affected FPMs presenting lesions on the occlusal surface;

3. Good general health conditions;

4. Sufficient cooperative behaviour;

5. Signature of the informed consent to the study by patients' parents or by their legal guardians

Exclusion Criteria:

1. FPMs presenting fluorosis, amelogenesis imperfecta, white spots, or other enamel defects that are in differential diagnosis with MIH;

2. FPMs presenting the occlusal surface already sealed or restored;

3. FPMs presenting occlusal cavitated caries (ICDAS Pit and Fissures = 3)

4. FPMs presenting severe PEB involving the dentin;

5. Children with orthodontic devices hiding FPMs.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glass ionomer sealant survival rate	Percentage of satisfactory status sealant in FPMs affected by MIH	At 12-month follow up