Clinical evaluation of bioactive composite resin in class v carious lesions: a split mouth study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- FDI criteria for clinical success
研究概览
简要总结
Dental resin composites have revolutionized dental care and enabled minimally invasive dentistry to preserve healthy tooth structure and provide natural-appearing esthetic results1.
Nevertheless, the development of recurrent caries at tooth-restoration interfaces still remains as one of the principal reasons for replacement of different kinds of restorations.
Based on this, one of the greatest challenges in the field of restorative dentistry involves the development of restorative biomaterials that have the ability of avoiding demineralization or promoting remineralization of hard dental tissues affected by caries 2.
Bioactive materials promote a biological response at the interface of the material and the tissue, generating a union between them3.
Manufacturers have claimed Bioactive dental materials help regulate the chemistry of teeth and saliva and contribute to the maintenance of oral health.
This type of bioactivity is known in the field to equate to stronger bonds between the restoration and tooth, penetration and filling of micro-gaps, reduction in sensitivity, guarding against secondary caries, and sealing of margins against microleakage and failure.
Such material is also indicated in cases where the isolation is compromised or impossible and in patients with high caries index due to its fluoride-releasing properties
3Mâ„¢ Filtekâ„¢ Bulk Fill Posterior Restorative (3M, ESPE) is a nanocomposite composite material showing no bioactive properties
Predicta Bioactive Bulk (PREDICTA, Parkell) is bioactive and releases calcium and phosphate ions and releases and recharges fluoride ions to stimulate mineral apatite formation and remineralization at the material-tooth interface.
Since bioactive composites have reminearlizing and antibacterial effect, we would like to evaluate the same properties in high caries risk individuals. Since there is no literature comparing the bioactive composites with non bioactive composites, we would like to evaluate the same in high caries risk patients.
PURPOSE OF STUDY:
To compare bioactive and non-bioactive composite resin in class V lesions of high-risk caries patients by using FDI criteria.
OBJECTIVES OF THE STUDY:
- To assess the marginal staining, marginal adaptation, marginal gap and recurrence of caries in bioactive composite Predicta Bioactive Bulk (PREDICTA, Parkell) in high caries risk patients using FDI criteria.
- To assess the marginal staining, marginal adaptation, marginal gap and recurrence of caries in non-bioactive composite 3Mâ„¢ Filtekâ„¢ Bulk Fill Posterior Restorative (3, ESPE) in high caries risk patients using FDI criteria.
- To compare bioactive and non-bioactive composites on the basis of marginal staining, marginal adaptation, marginal gap and recurrence of caries in high caries risk patients using FDI criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Teeth selection: Class v carious lesions with distinct cavitation exposing visible dentin Indicated for restoration without symptoms.
- •Posterior teeth only.
- •Surfaces involved: buccal only.
- •Dimensions of lesion Measured using a 12 UNC color-coded probe Mesiodistally- 2-4 mm Occlusogingivally – 2-4mm Depth – 1-2mm Presence of at least 2 cavitated class v lesions following criteria.
- •Patient selection: Age group of 18–60 years.
- •Ability to give informed consent.
- •Conditions indicative of a high caries risk patient.
- •In accordance with Caries Risk Assessment (Age >6) by ADA: Cavitated or Non-Cavitated (incipient) Carious Lesions or Restorations (visually or radiographically evident): 3 or more carious lesions or restorations in last 36 months.
排除标准
- •Teeth selection: •Teeth with non carious cervical lesions •Teeth with discoloration, developmental defects or pathological mobility.
- •Patient criteria: •Patients with parafunctional habits.
结局指标
主要结局
FDI criteria for clinical success
时间窗: baseline, 6 months, 12 months
次要结局
- over all patient caries reduction(baseline, 6 months, 12 months)