Clinical and radiographic evaluation of rose gold, gold and conventional stainless steel crowns in primary molars -an in vivo study
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:
-
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.
-
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
Aayushi Mehta
Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai
