Journal Article

Adhesive system containing Bioglass 45S5 particles in teeth affected by molar-incisor hypomineralization and quality of life impact: study protocol for a randomized clinical trial

Ferreira, Meire Coelho, Veras, Nicole Paiva, Carvalho, Ceci Nunes, de Oliveira Bauer, José Roberto, Cardenas, Andres Felipe Millan, da Costa, Kamila Nogueira Borges, de Siqueira, Fabiana Suelen Figuerêdo, Loguercio, Alessandro Dourado

2025

Overview

Background Molar-incisor hypomineralization (MIH) is a systemic condition characterized by a qualitative defect in the dental enamel. It primarily affects the first permanent molars and is often associated with the permanent incisors. Resin restorations in MIH-affected teeth consistently show worse results than those in normal teeth because of the ultrastructure of hypomineralized enamel, which compromises adhesion. The incorporation of bioactive particles into adhesives is a promising option for inducing remineralization. This study protocol describes a randomized clinical trial evaluating restorative treatment using an adhesive system containing 45S5 bioactive glass for MIH-affected teeth. Methods Restorations will be performed on the upper or lower first permanent molars in children with MIH aged 6–12 years. The inclusion criteria will include MIH teeth with post-eruptive enamel fractures that compromise the middle third of the dentin, with at least two surfaces of hypomineralized enamel near the cavity, without caries, pulpal, or periradicular involvement. Before treatment, children will complete the Child Perceptions Questionnaire 8–10 and 11–14 (CPQ8–10 and CPQ11–14). The teeth will be divided into two groups: a control group (commercial self-etching adhesive system: Clearfil SE Bond (CF) Primer + Bond) and an experimental group (CF Primer + experimental Bond using 10% 45S5 bioglass [Bond 45S5 10%]). Restorations will be made using composite resin, and quality will be assessed using digital radiographs (interproximal and periapical), intraoral photographs, and epoxy resin replicas. Clinical evaluation of the restorations will be performed immediately following the procedure (baseline) and after 1, 3, 6, and 12 months using the World Dental Federation (FDI) criteria. The impact of the treatment on the quality of life will be assessed after 3, 6, and 12 months through the re-administration of CPQ8–10 and CPQ11–14. Discussion 45S5 bioactive glass is capable of enhancing the effect of materials on bone and dental structures, promoting remineralization. The results of this study may aid in the clinical management of patients with MIH, given the challenges of treating sensitive and compromised teeth and the difficulty in achieving long-term restorative success while addressing the individual patient needs. Trial registration Rebec, U1111-1259-1738. Registered on January 10, 2021.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adhesives / Biomedical materials / Biomedicine / Biomineralization / Bond strength / Care and treatment / Ceramics - therapeutic use / Child / Clinical trials / Composite materials / Consent / Dental adhesives / Dental enamel / Dental Enamel Hypoplasia - diagnosis / Dental Enamel Hypoplasia - physiopathology / Dental Enamel Hypoplasia - psychology / Dental Enamel Hypoplasia - therapy / Dental glass ionomer cements / Dental restoration / Dental Restoration, Permanent - adverse effects / Dental Restoration, Permanent - methods / Dentin / Dentin-bonding agents / Dentistry / Female / Glass / Graduate studies / Health aspects / Health Sciences / Humans / Male / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / Molar / Molar Hypomineralization / Oral hygiene / Pediatrics / Permanent / Product development / Quality of Life / Randomized Controlled Trials as Topic / Statistics for Life Sciences / Study Protocol / Teeth / Testing / Time Factors / Tooth diseases / Tooth Remineralization - methods / Treatment Outcome