Clinical Evaluation of Injectable Bioactive Composites Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Tria
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Secondary Caries
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blinding of operators, patients, parents and outcome assessors was not possible as both materials differ in appearance and application technique.
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
RMGIC
cavity restorations in primary molars using a resin-modified glass ionomer cement. Following standard cavity preparation, the RMGI material will be placed according to the manufacturer's instructions. Clinical performance will be evaluated over the follow-up period in terms of restoration retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall clinical success.
干预措施: giomer (Other)
giomer
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.
干预措施: RMGI (Other)
结局指标
主要结局
Secondary Caries
时间窗: Baseline, 3, 6, and 12 months
Assessed using revised FDI criteria (B1: caries at restoration margin). Evaluated by visual examination and short air drying. Scored on ordinal scale 1-5.
次要结局
- Postoperative sensitivity / pulp status(Baseline, 3, 6, and 12 months)
- Marginal Adaptation(Baseline, 3, 6, and 12 months)
- Proximal Contact Point(Baseline, 3, 6, and 12 months)
- Occlusal Wear(Baseline, 3, 6, and 12 months)
- Fracture and Retention(Baseline, 3, 6, and 12 months)
研究者
Nadine elsayed Elshayal
Master's Student
Cairo University