COMPARISON OF CLINICAL EFFICACY OF GLASS IONOMER BASED SEALANT USING ART PROTOCOL AND RESIN BASED SEALANT ON PRIMARY MOLARS IN CHILDREN
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- retention of sealant
研究概览
简要总结
Title: Comparison of clinical efficacy of glass ionomer based sealant using ART protocol and resin based sealant on primary molars in children
Background and Objectives:
Dental caries is a site-specific disease that manifests predominantly in pits and fissures due to their morphology.1 Sealing the pits and fissures for prevention of dental caries has been proven to be highly effective.4
Two predominant types of sealants currently being used are resin based and glass ionomer cement (GIC) sealants. Highly viscous GIC, usually associated with atraumatic restorative treatment (ART), demonstrated increased retention than earlier developed low and medium viscosity GICs.It has also been observed that resin-based sealants show higher retention but are more technique sensitive.6
American Academy of Pediatric Dentistry (AAPD) recommends use of dental sealants for caries prevention in children aged 3 years and older.2 However, there is a paucity of studies on performance of ART sealants in primary molars.
Based on the clinical performance of ART sealants on permanent molars, null hypothesis is that the use of high-viscosity GIC as ART sealant will clinically perform comparably in primary molars also.
Thus, the aim of the present in-vivo study is to evaluate and compare the clinical efficacy and one year survival rate of resin based composite sealant (Clinpro Sealant, 3M ESPE, USA)with high viscosity glass ionomer (Equia Forte, GC India, India) using ART sealant protocol in primary molars.
Materials and Methods:
The design of the study will be clinical, prospective split mouth study. After initial screening, teeth fulfilling the inclusion criteria will randomly be allocated using lottery method to:
Group A –ART sealant (Equia Forte, GC India Dental Pte Ltd, Telangana, India)- Encapsulated glass ionomer
Group B –Resin based sealant (Clinpro Sealant, 3M ESPE, Minnesota, USA)
EquiaForte will be applied on a primary molar in one quadrant and Clinpro Sealant will be applied on the contralateral primary molar of the same dental arch.
Materials will be placed as per manufacturers instructions.
The follow up examinations will be scheduled at first month, sixth month and twelveth month intervals.
At each recall visit, Simonsen’s criteria will be used to check for the retention of sealants using CPI Probe. In case of sealant loss, ICDAS II will be used to check for caries**.**
The data obtained will be subjected to statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Otherwise healthy cooperative children with fully erupted primary molars.
- •2.Deep pits and fissures present in these primary molars.
- •[ICDAS II (International Caries Assessment and Detection System II)4 code 00] 3.Initial occlusal carious lesions involving the pits and fissures of enamel.
- •[ICDAS II code 01] 4.Incipient carious lesion involving enamel.
- •[ICDAS II code 02 and 03].
排除标准
- •1.Uncooperative child 2.Children whose parent does not give consent for the study.
- •3.Children with systemic disorders.
结局指标
主要结局
retention of sealant
时间窗: 1 month, 6 months, 12 months
次要结局
- dental caries according to ICDAS II criteria(1 month, 6 months, 12 months)