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

Overview

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).

Interventions

• 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 a
• 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 needl

Primary outcome measures

• 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.]

Secondary outcome measures (5)

• 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.]
• • 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.]
• • 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.]
• • 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.]
• • 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.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Cairo University — Cairo

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34699954

Identifiers

NCT: NCT06922552 · Faculty of Dentistry Cairo Uni

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗