Injectable Bioactive Composites vs RMGI for Proximal Cavities in Primary Molars

Clinical Evaluation of Injectable Bioactive Composites Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Tria

This randomized clinical trial aims to evaluate and compare the clinical performance of injectable bioactive composite (Beautifil Flow Plus X, Shofu) versus Resin Modified Glass Ionomer (RMGI) in restoring proximal cavities (Class II) in primary molars of children aged 3-8 years over a 12-month follow-up period, using revised FDI criteria.

Dental caries remains the most prevalent chronic disease in children. The choice of restorative material for primary teeth significantly impacts treatment outcomes and longevity. This study compares two fluoride-releasing restorative materials in proximal cavities of primary molars.

Eligible children aged 3-8 years with ICDAS 3 or 4 proximal carious lesions in primary molars will be randomly allocated into two equal groups (24 teeth each):

Group I (Intervention): Restoration with injectable bioactive giomer (Beautifil Flow Plus X F00, Shofu) using BeautiBond Xtreme adhesive Group II (Control): Restoration with Resin Modified Glass Ionomer (RMGI)

Restorations will be clinically evaluated at baseline, 3, 6, and 12 months using revised FDI criteria assessing biological properties (secondary caries, sensitivity, tooth integrity), functional properties (marginal adaptation, proximal contact, occlusal wear, fracture/retention), and aesthetic properties.

Inclusion Criteria:

• Children aged 3-8 years of both genders
• Cooperative behavior manageable by operators
• Willing to sign informed consent
• Accepts the follow-up period
• Moderate to low caries risk according to Cariogram application
• Posterior primary molar with proximal carious lesion (ICDAS 3 or 4) with no signs or symptoms of pulpal involvement
• Radiographically extending to outer 1/3 of dentin

Exclusion Criteria:

• Allergy to any restorative materials
• Patients undergoing orthodontic treatment with fixed appliances
• Patients with debilitating systemic diseases
• Children with special needs
• Teeth with previous restorations
• Periapical radiolucencies or sensitivity to percussion
• Mobile teeth
• External or internal resorption
• Cervical carious lesions