NCT05806398

Use of a Glass Ionomer Sealant in Molar Incisor Hypomineralization

Recruiting now Last updated 14 June 2024

What this trial tests

trial in Molar Incisor Hypomineralization in 15 participants. Currently enrolling.

Timeline

1 June 2022

Primary endpoint
15 January 2026

15 January 2026

Quick facts

Lead sponsor	IRCCS Burlo Garofolo
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	15
Start date	1 June 2022
Primary completion	15 January 2026
Estimated completion	15 January 2026
Sites	1 location across Italy

Conditions studied

• Molar Incisor Hypomineralization — all drugs for Molar Incisor Hypomineralization →

Sponsor

IRCCS Burlo Garofolo — full company profile →

Who can join

Adults 6 to 10, any sex, with Molar Incisor Hypomineralization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.