Injectable Bioactive Composites vs RMGI for Proximal Cavities in Primary Molars

N/ANot Yet RecruitingNCT07561216

Cairo University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Caries

Interventions

giomerOTHER

restoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material. Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding. Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period.

RMGIOTHER

Resin-Modified Glass Ionomer (RMGI) is a fluoride-releasing restorative material used for the restoration of carious primary teeth. It combines the properties of conventional glass ionomer cement with resin components to improve mechanical strength, adhesion, and moisture tolerance. In this study, RMGI will be used for restoring cavitated carious lesions in primary teeth following caries removal according to minimally invasive dentistry principles.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Secondary Caries

Assessed using revised FDI criteria (B1: caries at restoration margin). Evaluated by visual examination and short air drying. Scored on ordinal scale 1-5.