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Molar Incisor HypomineralizationNCT06922552

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

A study testing Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIH and Resin based sealant applied on Permanent Molars Affected by MIH in people with Molar Incisor Hypomineralization, run by Cairo University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 6 to 14 years
Conditions the study is for
Molar Incisor Hypomineralization
What is being tested?
Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIH and Resin based sealant applied on Permanent Molars Affected by MIH
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteEgypt
Study dates
Jun 2025to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nayera Mohammed Ali Ali, BDS contact

00201112666703

naira.ali@dentistry.cu.edu.eg

Egypt1 site

  • Cairo University

    Cairo

    Nayera Mohammed Ali Ali, BDS, 00201112666703, naira.ali@dentistry.cu.edu.egC

Other trials in Egypt

About this study

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

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?

Read the 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).
Being tested
Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIH, Resin based sealant applied on Permanent Molars Affected by MIH
Keywords
MIH, Giomer based sealants, Molar Incisor hypomineralization, Sealants, Rein based sealants
Medical subject headings
Molar Hypomineralization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIHProcedure or surgery

    • 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.

  • Resin based sealant applied on Permanent Molars Affected by MIHProcedure or surgery

    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.
Study groups in NCT06922552
Study groupRoleWhat they receive
Giomer based sealant applied on Permanent Molars Affected by MIHExperimental* 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
Receives: Procedure: Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIH
Resin based sealant applied on permanent molars affected by MIHActive comparator* 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.
Receives: Procedure: Resin based sealant applied on Permanent Molars Affected by MIH

What is being measured

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

  1. Sealant retention: Visual and tactile examination using dental mirror and dental probe using Modified (USPHS).

    Measured: at 3 month, at 6 month and at 12 month.

Secondary outcomes (5)

  1. Anatomic form: Using Modified (USPHS) Criteria Visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).

    Measured: at 3 month, at 6 month and at12 month.

  2. • Marginal adaptation: Using Modified (USPHS) Criteria visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).

    Measured: at 3 month, at 6 month and at 12 month.

  3. • Marginal discoloration: using Modified (USPHS) Criteria visual examination using dental mirror (Beste Özgür et al,2022).

    Measured: at 3 month, at 6 month and at 12 month.

  4. • Surface texture: using Modified (USPHS) Criteria visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).

    Measured: at 3 month, at 6 month and at 12 month.

  5. • Secondary caries: Using Modified (USPHS) Criteria visual and tactile examination using dental mirror and dental probe (Beste Özgür et al,2022).

    Measured: at 3 month, at 6 month and at 12 month.

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 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJun 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
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06922552
Sponsor's protocol ID
Faculty of Dentistry Cairo Uni
Status last verified
Apr 2025
First submitted
3 Apr 2025
Last updated
16 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 21. Singh D, Malik M, Mathur S. Comparative evaluation of clinical performance of giomer based and hydrophilic resin based pit and fissure sealant in primary molars: a split mouth clinical trial. J Pharm Negat Results. 2022;1883-9. 10.47750/pnr.2022.13.S04.229.

  • 20. Ratnaditya A, Kumar M, Sai SAJ, Zabirunnisa M, Kandregula CR, Kopuri R. Clinical evaluation of Retention in Hydrophobic and Hydrophillic pit and fissure Sealants-A Two Year Follow-Up study. J Young Pharmacists. 2015. 10.5530/jyp.2015.3.6.

  • Ozgur B, Kargin ST, Olmez MS. Clinical evaluation of giomer- and resin-based fissure sealants on permanent molars affected by molar-incisor hypomineralization: a randomized clinical trial. BMC Oral Health. 2022 Jul 5;22(1):275. doi: 10.1186/s12903-022-02298-9.

    PubMed 35790955

  • Lopes LB, Machado V, Mascarenhas P, Mendes JJ, Botelho J. The prevalence of molar-incisor hypomineralization: a systematic review and meta-analysis. Sci Rep. 2021 Nov 17;11(1):22405. doi: 10.1038/s41598-021-01541-7.

    PubMed 34789780

  • Inchingolo AM, Inchingolo AD, Viapiano F, Ciocia AM, Ferrara I, Netti A, Dipalma G, Palermo A, Inchingolo F. Treatment Approaches to Molar Incisor Hypomineralization: A Systematic Review. J Clin Med. 2023 Nov 20;12(22):7194. doi: 10.3390/jcm12227194.

    PubMed 38002806

  • Hassan AM, Mohammed SG. Effectiveness of Seven Types of Sealants: Retention after One Year. Int J Clin Pediatr Dent. 2019 Mar-Apr;12(2):96-100. doi: 10.5005/jp-journals-10005-1600.

    PubMed 31571779

  • Etman AM, Aboubakr RM, Alkhadragy D. Prevalence and predictors of molar-incisor hypomineralization among Egyptian children: a cross-sectional study. Eur Oral Res. 2024 Sep 5;58(3):120-126. doi: 10.26650/eor.20241394207.

    PubMed 39588477

  • Penha KJS, Roma FRVO, Filho EMM, Ribeiro CCC, Firoozmand LM. Bioactive self-etching sealant on newly erupted molars: A split-mouth clinical trial. J Dent. 2021 Dec;115:103857. doi: 10.1016/j.jdent.2021.103857. Epub 2021 Oct 24.

    PubMed 34699954

  • Wright JT, Tampi MP, Graham L, Estrich C, Crall JJ, Fontana M, Gillette EJ, Novy BB, Dhar V, Donly K, Hewlett ER, Quinonez RB, Chaffin J, Crespin M, Iafolla T, Siegal MD, Carrasco-Labra A. Sealants for Preventing and Arresting Pit-and-fissure Occlusal Caries in Primary and Permanent Molars. Pediatr Dent. 2016;38(4):282-308.

    PubMed 27557916

  • Toumba KJ, Twetman S, Splieth C, Parnell C, van Loveren C, Lygidakis NAlpha. Guidelines on the use of fluoride for caries prevention in children: an updated EAPD policy document. Eur Arch Paediatr Dent. 2019 Dec;20(6):507-516. doi: 10.1007/s40368-019-00464-2. Epub 2019 Nov 8.

    PubMed 31631242

  • Somani C, Taylor GD, Garot E, Rouas P, Lygidakis NA, Wong FSL. An update of treatment modalities in children and adolescents with teeth affected by molar incisor hypomineralisation (MIH): a systematic review. Eur Arch Paediatr Dent. 2022 Feb;23(1):39-64. doi: 10.1007/s40368-021-00635-0. Epub 2021 Jun 10.

    PubMed 34110615

  • Ntaoutidou S, Arhakis A, Tolidis K, Kotsanos N. Clinical evaluation of a surface pre-reacted glass (S-PRG) filler-containing dental sealant placed with a self-etching primer/adhesive. Eur Arch Paediatr Dent. 2018 Dec;19(6):431-437. doi: 10.1007/s40368-018-0379-z. Epub 2018 Oct 16.

    PubMed 30328064

  • Mohapatra S, Prabakar J, Indiran MA, Kumar RP, Sakthi DS. Comparison and Evaluation of the Retention, Cariostatic Effect, and Discoloration of Conventional Clinpro 3M ESPE and Hydrophilic Ultraseal XT Hydro among 12-15-year-old Schoolchildren for a Period of 6 Months: A Single-blind Randomized Clinical Trial. Int J Clin Pediatr Dent. 2020 Nov-Dec;13(6):688-693. doi: 10.5005/jp-journals-10005-1859.

    PubMed 33976497

  • Jorge RC, Dos Papoula GorniReis P, Maranon-Vasquez GA, Masterson D, Cople Maia L, Mendes Soviero V. Are yellow-brownish opacities in hypomineralized teeth more prone to breakage than white-creamy ones? A systematic review. Clin Oral Investig. 2022 Sep;26(9):5795-5808. doi: 10.1007/s00784-022-04536-4. Epub 2022 May 14.

    PubMed 35568765

  • Hjertberg E, Hajdarevic A, Jalevik B. Desensitization treatment in MIH-affected teeth: a systematic review. Eur Arch Paediatr Dent. 2025 Feb;26(1):17-29. doi: 10.1007/s40368-024-00934-2. Epub 2024 Aug 13.

    PubMed 39136874

Questions about this trial

What is this clinical trial studying?

A study testing Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIH and Resin based sealant applied on Permanent Molars Affected by MIH in people with Molar Incisor Hypomineralization, run by Cairo University at 1 site in Egypt.

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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Apr 2025. 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 Egypt. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Nayera Mohammed Ali Ali, BDS (00201112666703, naira.ali@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06922552, which also lists 21 linked publications.

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 16 Apr 2025.

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