跳至主要内容
临床试验/CTRI/2020/09/027729
CTRI/2020/09/027729尚未招募1 期

Evaluation of streptococcus mutans colonization and oral hygiene status in primary molars restored with two different crowns-A randomized clinical trial

DrJAAmilia Elizabeth1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年9月20日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
1.To assess and compare the amount of streptococcus mutans colonization on SSC and zirconia crowns at 1month.

研究概览

简要总结

This study is aimed to evaluate the adhesion of streptococcus mutans count on two different crowns- stainless steel crowns and zirconia on primary molars. It is a randomized control trial with split mouth design. The sample size is estimated to be 32 with 1:1 allocation ratio, simple random sampling. The methodology includes the collection of baseline swabs from the buccal mucosa of the tooth to be restored with the crown at the beginning of the study. The post operative swabs will be collected from both the crowns at one month interval. streptococcus mutans will be cultured in the selective medium of mitus salivarius bacitracin agar for its growth. the colony forming units will be counted using colony forming counter. the plaque, ginigival and oral hygiene indices will be recorded at 1month, 3 month, 9 month and 12 month interval. 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
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

  • 1.Age group between 4 to 07 yrs 2.Presence of atleast two carious primary molars indicated for pulp therapy on either side.
  • (split mouth technique).
  • 3.No history of antibiotic intake for past two weeks.
  • 4.No history of fluoride application for past two weeks.

排除标准

  • 1.Special children with physical or emotional alteration.
  • 2.Children with systemic diseases .
  • 3.Grossly decayed, unrestorable teeth, with maximum space loss.
  • 4.Caries in primary teeth exhibiting pre shedding mobility.

结局指标

主要结局

1.To assess and compare the amount of streptococcus mutans colonization on SSC and zirconia crowns at 1month.

时间窗: 1month.

次要结局

  • To assess and compare the gingival health and radiographic assessment following SSC and zirconia crown placement at 1month,3month,6month and 12 month follow up.(1 month,3 month,6 month,12 month)

研究者

发起方
DrJAAmilia Elizabeth
申办方类型
Other [self]

研究点 (1)

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