Clinical trial NCT06922552: Clinical Performance of Giomer Preceded by Etching Versus Resin-Based Sealants Applied on Permanent Molars Affected by Molar-Incisor Hypo-mineralization
Official title: Clinical Performance of Giomer Preceded by Etching Versus Resin-Based Sealants Applied on Permanent Molars Affected by Molar-Incisor Hypo-mineralization: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Molar Incisor Hypomineralization
Keywords: MIH
Giomer based sealants
Molar Incisor hypomineralization
Sealants
Rein based sealants
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to evaluate the clinical performance of giomer sealant preceded by etching versus resin-based sealants applied on first permanent molars affected by molar incisor hypomineralization (MIH)

The main question it aims to answer is :

Will the use of Giomer (Beautisealant, Shofu, Kyoto, Japan) Preceded by Etching result in similar clinical performance as Resin-Based Sealants(UltraSeal XT™ Plus™ by Ultradent) Applied on Permanent Molars Affected by Molar-Incisor Hypomineralization?

Detailed description: Molar Incisor Hypomineralization (MIH) is a developmental defect impacting first permanent molars and incisors, characterized by enamel opacities, and reduced mineral content. This condition can cause aesthetic, functional, psychological, and behavioral problems in children. Moreover, there are dental treatment challenges associated with (MIH)which include behavior management, difficulty with local anesthesia, tooth hypersensitivity, and issues with restoration retention.

Teeth affected by (MIH) are more susceptible to dental caries due to weaker enamel properties and increased sensitivity during brushing. Research indicates that individuals with (MIH) experience higher rates of dental caries and require more frequent treatments. Therefore, it is crucial to implement a comprehensive preventive strategy as soon as lesions are detected on erupting first permanent molars. (MIH) can be categorized by the severity and extent of lesions, with three main degrees: mild, moderate, and severe. The mild form is characterized by opaque white discolorations of the enamel. Moderate cases show more significant discolorations, varying from yellow to brown. In severe cases, there is not only discoloration but also a marked loss of hard tissue, resulting in cavities or enamel fractures.

A systematic review done recommended the use of fissure sealants for mild cases of (MIH) in which first permanent molars do not exhibit posteruptive breakdown (PEB) and highlighted that Resin-based sealants are the most frequently utilized materials for this purpose.

creation of pre-reacted glass ionomer (PRG) filler technology in 1999 , which involves dispersing fluoroaluminosilicate glass particles that have already reacted with polyacrylic acid into resin. Building on this, a new hybrid material known as giomer was introduced, utilizing a bioactive surface pre-reacted glass (S-PRG) filler that merges the benefits of resin composites with those of glass ionomer cements Current evidence suggests that Phosphoric acid etching is the preferred method for sealing pits and fissures as it increases the retention rates. However, more high-quality multicenter randomized controlled trials are needed to explore the relationship between clinical effectiveness, retention rates especially in molars affected by (MIH) sealed by giomer-based fissure sealant preceded by etching using phosphoric acid etchant.

The benefits of this study to the participants:

1. Prevention of Complications: Early intervention can help prevent further enamel degradation and associated complications, e.g., Caries.
2. Improved Patient Comfort: Addressing hypersensitivity and pain early can enhance patient comfort.
3. Cost-Effectiveness: Preventive measures and early treatments can reduce overall treatment costs.

The benefits of this study to the clinicians:

1. Easier Management: Treating (MIH) when the condition is less severe allows for simpler and less invasive procedures.
2. Offering good alternative solutions for mild (MIH).

The benefits of this study to the population:

• Education Opportunities: Early diagnosis and treatment provide an opportunity for dentists to educate patients and families about oral health and the importance of regular dental visits and help them having better quality of life and prevent complications of untreated (MIH).

Eligibility criteria: Inclusion Criteria:

* Healthy children aged 6-14 years who are diagnosed with mild (MIH) according to European Academy of Pediatric Dentistry (EAPD) criteria which includes demarcated enamel opacities (white, creamy, or yellow to brownish), that may induce sensitivity to external stimuli without enamel breakdown.

  * Cooperative children.
  * Presenting at least one first permanent molar (FPMs) that were fully erupted and indicated for non-invasive fissure sealant.
  * Medically fit Children (ASA I).

Exclusion Criteria:

* Children have hypomineralized (FPMs) with post-eruptive breakdown, cavitated and non-cavitated carious lesions, restorations, or fixed orthodontic appliances.
* Enamel defects due to a condition other than (MIH).
* Parents are not willing to join.
* Molars that cannot be isolated using rubber dam.
* Uncooperative children.
* Medically unfit children (other than ASA I).

Primary outcomes:
measure: Sealant retention: Visual and tactile examination using dental mirror and dental probe using Modified (USPHS).
timeFrame: at 3 month, at 6 month and at 12 month.
Secondary outcomes:
measure: Anatomic form: Using Modified (USPHS) Criteria Visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).
timeFrame: at 3 month, at 6 month and at12 month.
measure: • Marginal adaptation: Using Modified (USPHS) Criteria visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).
timeFrame: at 3 month, at 6 month and at 12 month.
measure: • Marginal discoloration: using Modified (USPHS) Criteria visual examination using dental mirror (Beste Özgür et al,2022).
timeFrame: at 3 month, at 6 month and at 12 month.
measure: • Surface texture: using Modified (USPHS) Criteria visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).
timeFrame: at 3 month, at 6 month and at 12 month.
measure: • Secondary caries: Using Modified (USPHS) Criteria visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).
timeFrame: at 3 month, at 6 month and at 12 month.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
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