Comparative Evaluation of Bioactive Resin Modified, Glass Hybrid and Conventional GIC in Class II Restorations of Primary Molars: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Assess the clinical efficacy of ACTIVA BioACTIVE, Equia forte(glass hybrid) and conventional GIC in restoring class II carious lesions in primary molars.
研究概览
简要总结
IntroductionDental materials for Class II restorations in primary molars play a critical role in pediatric dentistry. This study aims to evaluate and compare the clinical performance of three restorative materials: ACTIVA BioACTIVE, EQUIA Forte, and Conventional Glass Ionomer Cement (GIC). The evaluation focuses on factors such as retention, marginal integrity, and post-operative sensitivity.
Materials and MethodsThe study enrolled pediatric patients requiring Class II restorations on primary molars. The materials used were:
- ACTIVA BioACTIVE: A bioactive composite resin known for releasing and recharging fluoride and enhancing tooth structure.
- EQUIA Forte: A glass hybrid restorative system with high wear resistance and fluoride release.
- Conventional GIC: A traditional restorative material with chemical adhesion and fluoride-releasing properties.
Restorations were placed following standardized protocols. Clinical assessments were conducted at baseline, 3 months, 6 months, and 12 months. Parameters evaluated included retention, marginal adaptation, surface roughness, and post-operative sensitivity.
DiscussionThe study highlights that ACTIVA BioACTIVE and EQUIA Forte outperform Conventional GIC in retention, marginal adaptation, and surface smoothness. ACTIVA BioACTIVE’s bioactive properties contribute to enhanced tooth remineralization and stress absorption, while EQUIA Forte’s glass hybrid technology offers superior mechanical strength and fluoride release.
Conventional GIC, despite its fluoride-releasing ability, displayed inferior performance due to its lower mechanical strength and increased surface roughness, which can lead to plaque retention and secondary caries.
ConclusionACTIVA BioACTIVE emerged as the most effective material for Class II restorations in primary molars, followed closely by EQUIA Forte. Conventional GIC, while still a viable option, showed limitations in long-term durability and surface smoothness. These findings support the use of bioactive and hybrid materials for improved clinical outcomes in pediatric restorative dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Occluso-proximal cavities in the primary maxillary and mandibular molars, International Caries Detection and Assessment System II (ICDAS II) codes 4 and 5
- •Asymptomatic, vital teeth without pulpal involvement.
- •Patient without systemic diseases that may interfere with dental treatment.
- •Teeth without any developmental defects such as hypomineralisation, hypoplasia, and fluorosis.
排除标准
- •Primary molars with extensive loss of tooth structure that exceeds the suitability for a Class II restoration.
- •Teeth with periodontal or periapical pathology.
- •Patients with a history of adverse reactions to restorative dental materials.
- •Severe developmental or cognitive impairment that interferes with cooperation during dental procedure.
- •Inability of the patient to comply with the follow-up examinations and the requirements of the study.
结局指标
主要结局
Assess the clinical efficacy of ACTIVA BioACTIVE, Equia forte(glass hybrid) and conventional GIC in restoring class II carious lesions in primary molars.
时间窗: 1,6 and 12 months
次要结局
- To compare three materials in terms of Esthetic, Biological and Functional properties.(1, 6 and 12 months)
研究者
Mayuri Sopan Mundhe
King Georges Medical University