CTRI

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CTRI Number

CTRI/2025/03/081966 [Registered on: 07/03/2025] Trial Registered Prospectively

Last Modified On:

18/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Clinical and radiographic evaluation of 3 types of crowns in primary molar teeth : an in vivo study

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Aayushi Mehta
Designation	post graduate student
Affiliation	Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai
Address	Department of pediatric and preventive dentistry, basement, Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai Dr D.Y.Patil Vidyanagar , Sector 7 , Nerul, Navi Mumbai Thane MAHARASHTRA 400706 India
Phone	9867774502
Fax
Email	aayushimehta57@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Mansi Baviskar
Designation	Professor
Affiliation	Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai
Address	Department of pediatric and preventive dentistry, basement, Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai . Dr D.Y.Patil Vidyanagar , Sector 7 , Nerul, Navi Mumbai Thane MAHARASHTRA 400706 India
Phone	9867774502
Fax
Email	mansi.baviskar@dypatil.edu

Details of Contact Person
Public Query

Name	Aayushi Mehta
Designation	post graduate student
Affiliation	Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai
Address	Department of pediatric and preventive dentistry, basement, Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai . Dr D.Y.Patil Vidyanagar , Sector 7 , Nerul, Navi Mumbai Thane MAHARASHTRA 400706 India
Phone	9867774502
Fax
Email	aayushimehta57@gmail.com

Source of Monetary or Material Support

Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai Dr D.Y.Patil Vidyanagar , Sector 7 , Nerul, Navi Mumbai- 400706, Maharashtra, India

Primary Sponsor

Name	Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai
Address	Dr. D.Y.Patil Vidyanagar, Sector 7 , Nerul, Navi Mumbai-400706
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DrAayushi Mehta	Dr D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai	Department of pediatric and preventive dentistry, basement, Dr. D.Y.Patil Vidyanagar, Sector 7 , Nerul ,Navi Mumbai-400706 Thane MAHARASHTRA	9867774502 aayushimehta57@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Research and ethical board D.Y.Patil deemed to be university, School of dentistry, Navi Mumbai	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K029\|\|Dental caries, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Conventional stainless steelcrown	Commonly used in pediatric dentistry The procedure for use of this crown : 1.Administration of local anaesthetic infiltration using 2% lignocaine 1:80:000 adrenaline 2.Selection of crown size 3.Tooth preparation 4.Placement and adaptation of crown 5.Cementation
Intervention	Gold stainless steel crown	Gold stainless steel crown is similar to conventional stainless crowns in terms of its composition with an additional 5 micron layer of titanium oxide. The procedure for use of this crown : 1.Administration of local anaesthetic infiltration using 2% lignocaine 1:80:000 adrenaline 2.Selection of crown size 3.Tooth preparation 4.Placement and adaptation of crown 5.Cementation
Intervention	rose gold stainless steel crown crown	Rose gold stainless steel crown is similar to conventional stainless crowns in terms of its composition with an additional 5 micron layer of titanium oxide. The procedure for use of this crown : 1.Administration of local anaesthetic infiltration using 2% lignocaine 1:80:000 adrenaline 2.Selection of crown size 3.Tooth preparation 4.Placement and adaptation of crown 5.Cementation

Inclusion Criteria

Age From	4.00 Year(s)
Age To	8.00 Year(s)
Gender	Both
Details	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

ExclusionCriteria

Details

I. 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

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
primary outcome is to assess the clinical and radiographic parameters of rose gold, gold and conventional stainless steel crowns clinical parameters to be assessed : 1 Proximal contact 2 occlusion 3 Gingival index 4 Plaque index 5 Color change 6 Retention Radiographic Marginal adaptation	baseline one month follow up three months follow up six months follow up

Secondary Outcome

Outcome	TimePoints
to see the colour change or any tarnish or corrosion in rose gold and gold stainless steel crowns	one month 3 months six months

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

11/03/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

11/03/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

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

Methodology

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

Selection of crown

Tooth preparation

Placement and adaptation of crown

Cementation