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Molar Incisor HypomineralizationNCT05806398

Use of a Glass Ionomer Sealant in Molar Incisor Hypomineralization

An observational study of Molar Incisor Hypomineralization, run by IRCCS Burlo Garofolo at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 6 to 10 years
Conditions the study is for
Molar Incisor Hypomineralization
How many people
15 participants
Where
1 siteItaly
Study dates
1 Jun 2022to 15 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 10 years
  • All sexes
  • Child

Study population: Children aged between 6 and 10 years with erupted MIH affected FPMs presenting lesions on the occlusal surface

Who may be able to join

  • FPMs of children aged between 6 and 10 years;
  • Erupted MIH affected FPMs presenting lesions on the occlusal surface;
  • Good general health conditions;
  • Sufficient cooperative behaviour;
  • Signature of the informed consent to the study by patients' parents or by their legal guardians

Who cannot join

  • FPMs presenting fluorosis, amelogenesis imperfecta, white spots, or other enamel defects that are in differential diagnosis with MIH;
  • FPMs presenting the occlusal surface already sealed or restored;
  • FPMs presenting occlusal cavitated caries (ICDAS Pit and Fissures ≥ 3)
  • FPMs presenting severe PEB involving the dentin;
  • Children with orthodontic devices hiding FPMs.

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • IRCCS Burlo Garofolo

    Trieste, 34137

    Milena Cadenaro, MD, +390403785, milena.cadenaro@burlo.trieste.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the detailed 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.

Keywords
Molar Incisor Hypomineralization (MIH) Molars, Glass ionomer sealant, Prevention
Medical subject headings
Molar Hypomineralization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glass ionomer sealant survival rate

    Percentage of satisfactory status sealant in FPMs affected by MIH

    Measured: At 12-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2023
  2. Study start1 Jun 2022
  3. Primary completion15 Jan 2026 (estimated)
  4. Study completion15 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05806398
Sponsor's protocol ID
RC 50/22
Status last verified
Jun 2024
First submitted
28 Mar 2023
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Molar Incisor Hypomineralization, run by IRCCS Burlo Garofolo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Milena Cadenaro, MD (+390403785111, milena.cadenaro@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glass ionomer sealant survival rate (time frame: At 12-month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

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