Clinical Performance of Giomer Preceded by Etching Versus Resin-Based Sealants Applied on Permanent Molars Affected by Molar-Incisor Hypo-mineralization

April 11, 2025 updated by: Nayera Mohammed, Cairo University

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Giomer based sealant applied on Permanent Molars Affected by MIH
  • Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow).
  • Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel An adequate amount of primer will be dispensed on the enamel surface of the pit and fissure using a brush then will be left undisturbed for 5sec. Gentle air blow for 3 sec and then dryness with stronger stream of air until a thin and uniform bonding layer is obtained.
  • The giomer sealant (BeautiSealant, Shofu, Kyoto, Japan) will be applied into the occlusal fissures applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the fl
Procedure: Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIH
  • Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow).
  • Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel An adequate amount of primer will be dispensed on the enamel surface of the pit and fissure using a brush then will be left undisturbed for 5sec. Gentle air blow for 3 sec and then dryness with stronger stream of air until a thin and uniform bonding layer is obtained.
  • The giomer sealant (BeautiSealant, Shofu, Kyoto, Japan) will be applied into the occlusal fissures applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the flow.
Active Comparator: Resin based sealant applied on permanent molars affected by MIH
  • Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow).
  • Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel
  • The resin sealant will be applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the flow into the pit and fissures. Photo - curing for the sealant will be done for 20 seconds using LED light curing unit. The tip of the light will be held as close as possible to the sealant, without actually touching the sealant.
Procedure: Resin based sealant applied on Permanent Molars Affected by MIH

Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow).

  • Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel
  • The resin sealant (UltraSeal XT™ hydro™) will be applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the flow into the pit and fissures. Photo - curing for the sealant will be done for 20 seconds using LED light curing unit. The tip of the light will be held as close as possible to the sealant, without actually touching the sealant.

the surfaces will be checked with an explorer to ensure that no voids were present.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sealant retention: Visual and tactile examination using dental mirror and dental probe using Modified (USPHS).
Time Frame: at 3 month, at 6 month and at 12 month.
at 3 month, at 6 month and at 12 month.

Secondary Outcome Measures

Outcome Measure
Time Frame
Anatomic form: Using Modified (USPHS) Criteria Visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).
Time Frame: at 3 month, at 6 month and at12 month.
at 3 month, at 6 month and at12 month.
• Marginal adaptation: Using Modified (USPHS) Criteria visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).
Time Frame: at 3 month, at 6 month and at 12 month.
at 3 month, at 6 month and at 12 month.
• Marginal discoloration: using Modified (USPHS) Criteria visual examination using dental mirror (Beste Özgür et al,2022).
Time Frame: at 3 month, at 6 month and at 12 month.
at 3 month, at 6 month and at 12 month.
• Surface texture: using Modified (USPHS) Criteria visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).
Time Frame: at 3 month, at 6 month and at 12 month.
at 3 month, at 6 month and at 12 month.
• Secondary caries: Using Modified (USPHS) Criteria visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).
Time Frame: at 3 month, at 6 month and at 12 month.
at 3 month, at 6 month and at 12 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Faculty of Dentistry Cairo Uni

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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