Evaluation of the Aesthetic and Functional Properties of A Universal One-Shade Composite Material With Chameleon-like Properties: A Longitudinal Split-Mouth Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Surface Luster and Surface texture
研究概览
简要总结
- Use of tooth-coloured fillings is an essential part of Pediatric dentistry as most patients desire fillings which look like natural teeth.
- Lately, there is a vast variety of shade-choices in filling materials which complicates colour matching procedure, increases cost and increases treatment time.
- Universal One shade composite filling materials have been developed to overcome these disadvantages. Omnichroma (Tokuyama Dental, USA) is one such material, introduced in 2019.
- Manufacturer claims that it can match colour of surrounding tooth, irrespective of its shade, which may be an advantage for patients as well as pediatric dentists.
- In child patients where chairside time, child's cooperation are important, this new one shade filling material Omnichroma, may prove to be better than multi shade composite filling materials, regarding color matching, color stability and other functional properties.
- There are very few studies on this new material, that have assessed its actual performance in patients, and more studies would be useful to generate scientific evidence for dentists to use.
- In this study we will fill one of your child's decayed front tooth with the new One shade filling material Omnichroma, and the other decayed front tooth with the usual conventional multi shade filling material 3M Filtek Z350 after colour matching followed by evaluation and taking of intraoral photographs.
- You would be required to report for follow ups at 3, 6 and 12 months interval for a repeat evaluation and intraoral pictures.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age group of 3-5 years
- •Carious lesions in both primary maxillary central incisors involving enamel or enamel and dentin only
- •Similar extent of carious lesion in both primary maxillary central incisors
- •Willing to give informed consent
- •Willing to return for evaluations and follow up
排除标准
- •Presence of pre shedding mobility
- •Deep carious lesions
- •Signs or symptoms of pulpal involvement
- •Presence of abscess, sinus tract, root resorption
- •Highly uncooperative patients
- •Medically compromised patients
- •Children with special health care needs
结局指标
主要结局
Surface Luster and Surface texture
时间窗: Baseline, 3 months, 6 months, and 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Marginal adaptation
时间窗: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Marginal staining
时间窗: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Fracture of material and retention
时间窗: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Colour match
时间窗: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
次要结局
- Photographic/Digital Colour match(Baseline, 3 months, 6 months, 12 months)
- Photographic/ Digital Colour stability(Baseline, 3 months, 6 months, 12 months)
研究者
Ruhi Sanvordekar
Post Graduate student, Department of Pediatric and Preventive Dentistry
Goa Dental College