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临床试验/CTRI/2025/03/081966
CTRI/2025/03/081966尚未招募不适用

Clinical and radiographic evaluation of rose gold, gold and conventional stainless steel crowns in primary molars -an in vivo study

Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月11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
90
试验地点
1
主要终点
primary outcome is to assess the clinical and radiographic parameters of rose gold, gold and conventional stainless steel crowns

研究概览

简要总结

Dental caries is one of the most prevalent chronic diseases, affecting nearly 60 to 90% of the world’s population. Management of dental caries in primary teeth includes preventive, restorative as well as pulp therapy. Stainless steel crowns were introduced into pediatric dentistry in 1947, first described by Engel, and then popularised by Humphrey in 1950.Scientific evidence favours stainless steel crowns as restoration of choice in young children with high caries risk.New crowns like the rose gold and gold SSC crowns have been introduced .  These crowns have a titanium coated layer of 0.05 microns of rose gold and gold crowns respectively as given by the manufacturer. However there is no study which evaluates the clinical and radiographic success of rose gold,  gold and conventional SSC crowns. Therefore the aim and objective of this study is as follows:

  1. To evaluate the clinical parameters of rose gold ,gold, and conventional stainless steel crowns in primary dentition based on  occlusion , gingival index ,plaque index, retention, indentation at  one, three and six months  follow up.

  2. To compare the colour change of rose gold , gold and stainless steel crowns in primary dentition at one , three and  six months.

3.To evaluate radiographically the marginal adaptation of the crown

According to inclusion criteria,90 children were divided into 3 groups

Group 1“rose gold SSC crowns, Group 2 gold  stainless steel crowns and group 3 conventional SSC crowns .The following outcomes will be measured at baseline and then at intervals of 1,3,and 6 months

Clinical: The following paramaters will be checked clinically

Proximal contact

occlusion

Gingival index

Plaque index

Colour change

Retention

Radiographic parameter**:**

Marginal adaptation

MethodologyAdministration of local anaesthetic infiltration using 2% lignocaine 1:80:000 adrenaline

Selection of crown

Tooth preparation

Placement and adaptation of crown

Cementation

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • 1.Children aged four to eight years old who are healthy and free of any systemic disease 2.Deciduous teeth indicated for crowns 3.Deciduous teeth having two-thirds of root structure left radiographically 4.Teeth with wide proximal caries and multisurface caries involving enamel and dentin.
  • 5.Post pulpectomy and pulpotomy procedures.

排除标准

  • Teeth indicated for extraction II.
  • Patients who do not give consent for participation in the study III.
  • Teeth with physiological root resorption of more than one-third of root length IV.
  • Adjacent teeth that require crowns.

结局指标

主要结局

primary outcome is to assess the clinical and radiographic parameters of rose gold, gold and conventional stainless steel crowns

时间窗: baseline | one month follow up | three months follow up | six months follow up

clinical parameters to be assessed :

时间窗: baseline | one month follow up | three months follow up | six months follow up

1 Proximal contact

时间窗: baseline | one month follow up | three months follow up | six months follow up

2 occlusion

时间窗: baseline | one month follow up | three months follow up | six months follow up

3 Gingival index

时间窗: baseline | one month follow up | three months follow up | six months follow up

4 Plaque index

时间窗: baseline | one month follow up | three months follow up | six months follow up

5 Color change

时间窗: baseline | one month follow up | three months follow up | six months follow up

6 Retention

时间窗: baseline | one month follow up | three months follow up | six months follow up

Radiographic

时间窗: baseline | one month follow up | three months follow up | six months follow up

Marginal adaptation

时间窗: baseline | one month follow up | three months follow up | six months follow up

次要结局

  • to see the colour change or any tarnish or corrosion in rose gold and gold stainless steel crowns(one month)

研究者

发起方
Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Aayushi Mehta

Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai

研究点 (1)

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