跳至主要内容
临床试验/CTRI/2024/02/063350
CTRI/2024/02/063350尚未招募不适用

Evaluation of clinical performance of carious primary molars restored with two bioactive restorative materials in 4-8 year old children

Dr Gontla Devi Saranya1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Marginal adaptation, Surface roughness, Secondary caries and Marginal staining

研究概览

简要总结

Dental composites have been traditionally used aesthetic restorative materials. However secondary caries beneath and around the restorative materials is the most common cause of failure of composite resin restorations. The majority of the available composite resins have no remineralizing effect.In order to overcome these disadvantages of composite resins, there is a increasing  tendency to use resin based bioactive and remineralizing restorative materials to increase the durability of bonded restorations. In restorative dentistry, the term bioactive usually refers to the ability of a material to form  hydroxyapatite crystals on its surface. Bioactive materials are moisture friendly and  imitate nature and participate in dynamic ionic exchange.  Release of different remineralizing ions from the restorative materials into oral cavity and at the tooth restoration interface improves the longevity of restoration and decreases the rate of recurrent caries. Screening of 4-8 year old patients attending the outpatient department will be done. Details of the study will be explained to the patients and parents, with written informed consent obtained.Considering inclusion and exclusion criteria, children with bilateral occlusal caries will be included and random allocation in to two groups will be done with split mouth design. Group 1 will be restored with cention n and group 2 will be restored with active bioactive restorative materials. Post operative occlusal evaluation will be done using articulating paper and final adjustments will be done if required with finishing burs. Follow-up will be done at 6 and 12 months intervals and marginal adaptation, surface roughness, secondary caries and  marginal staining will be evaluated using modified USPHS criteria. Statistical analysis will be done using non parametric tests, inter groupe comparison will be done using Mann Whitney ‘’ U’’  test and intragroup comparison will be done at 6 and 12 months intervals using Wilcoxon sign rank test .

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 8.00 Year(s)(—)
性别
All

入选标准

  • Primary molars with bilateral occlusal caries in
  • 4-8 year old children(ICDAS score 4/5 )
  • Co-operative children.

排除标准

  • Medically compromised patients.
  • Teeth with developmental defects.
  • Teeth that are un-restorable
  • Teeth with signs and symptoms of pain or swelling.

结局指标

主要结局

Marginal adaptation, Surface roughness, Secondary caries and Marginal staining

时间窗: At 6 and 12 months after the restoration is done

次要结局

未报告次要终点

研究者

发起方
Dr Gontla Devi Saranya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Gontla Devi Saranya

Vishnu Dental Collage

研究点 (1)

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