| CTRI Number |
CTRI/2025/09/095078 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on Gold and Rose Gold Crowns in Kids: Cleanliness, Comfort, and Parental Views |
|
Scientific Title of Study
|
Comparative Evaluation of Parental Satisfaction, Patient Acceptance and Clinical Success of Stainless Steel Crown and Titanium Coated Preformed Primary Crowns.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Maheshkumar |
| Designation |
Assitant Professor |
| Affiliation |
SRI SIDDHARTHA DENTAL COLLEGE |
| Address |
Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107
Sri siddhartha academy of higher education.Tumkur.Karnataka.India.
Tumkur KARNATAKA 572107 India |
| Phone |
7010950226 |
| Fax |
|
| Email |
kmaheshkumarbds@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Maheshkumar |
| Designation |
Assitant Professor |
| Affiliation |
SRI SIDDHARTHA DENTAL COLLEGE |
| Address |
Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107
Sri siddhartha academy of higher education.Tumkur.Karnataka.India.
Tumkur KARNATAKA 572107 India |
| Phone |
7010950226 |
| Fax |
|
| Email |
kmaheshkumarbds@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K Maheshkumar |
| Designation |
Assitant Professor |
| Affiliation |
SRI SIDDHARTHA DENTAL COLLEGE |
| Address |
Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107
Sri siddhartha academy of higher education.Tumkur.Karnataka.India. Room No:6
Department of Pedodontics
Sri Siddhartha Dental College and Hospital Tumkur Karnataka
India Tumkur KARNATAKA 572107 India |
| Phone |
7010950226 |
| Fax |
|
| Email |
kmaheshkumarbds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107
Sri siddhartha academy of higher education.Tumkur.Karnataka.India. |
|
|
Primary Sponsor
|
| Name |
Dr K Maheshkumar |
| Address |
Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107
Sri siddhartha academy of higher education.Tumkur.Karnataka.India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MAHESHKUMAR K |
Sri Siddhartha Dental College and Hospital |
Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107
Sri siddhartha academy of higher education.Tumkur.Karnataka.India.
Tumkur KARNATAKA |
7010950226
kmaheshkumarbds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SIDDHARTHA DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gold crown , Rose gold Esthetic crown |
Evaluating the parental and children acceptence for gold and rose gold crown
this study follow up will do up to 9 months
Total duration: 12 months |
| Comparator Agent |
stainless steel crown |
evaluating the parental and children acceptence for stainless steel crown
this study follow up will do up to 9 months
Total duration: 12 months |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Cooperative and healthy children between 4 and 9 years
2. Children underwent pulpectomy or pulpotomy-treated teeth with two-thirds of the root present.
3. Children without any more internal/external resorption
|
|
| ExclusionCriteria |
| Details |
1. Teeth frankly infected either abscess, sinus tract or obvious inter radicular radiolucency.
2. Presence of any systemic disorders.
3. Special health care need children.
|
|
|
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 |
| child and parental acceptence an d and satisfaction |
placemnt differnt type of esthetic crown
4 weeks - follow up
3 months - follow up
9 months -follow up
12 months -follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical success of gold crown rose gold crown |
placemnt differnt type of esthetic crown
4 weeks - follow up
3 months - follow up
9 months -follow up
12 months -follow up |
|
|
Target Sample Size
|
Total Sample Size="39" Sample Size from India="39"
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)
|
07/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" 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 main global burden on oral health. Almost one-third of the world’s population, are affected by dental caries, one of the most common and ubiquitous pathological illnesses. Dental Caries in primary teeth can cause discomfort, affect speech and loss of confidence.1 Since primary teeth are necessary for chewing, speaking, and maintaining natural space in the dental arch, it is essential that they receive proper care.2 Selecting an appropriate restoration technique is a crucial step in achieving best treatment outcomes. The most common restoration material is glass ionomers, composite resin, compomer, amalgam, or prefabricated crowns.3 Preformed Stainless steel crowns/ zirconia crowns are the most commonly used treatment modality for extensive carious lesions. The superiority and durability of stainless-steel crowns over multi-surface amalgam and other restorations in the primary dentition have made preformed SSC crown an invaluable restorative technique for the treatment of grossly decayed primary teeth.4 The major disadvantage of stainless steel crown was its aesthetics. Zirconia crown which is introduced as a newer material as a result of technological advancements is highly acceptable to parents and children due to excellent esthetics, resistance to fracture, biocompatibility, reduced plaque accumulation, colour stability, and potentially less technique sensitivity.5 But due to extensive tooth reduction because of their inflexibility and thickness, it is time consuming and can cause discomfort to the children. Titanium-nitride coated crown (TiNC) is a recently introduced full coverage crown with a titanium-nitride (TiN) coating on its surface,the titanium-nitride (TiN) coating makes the crown look yellow or gold in colour and also strengthens the hardness of the surface.6 Recently another titanium-nitride coated crown, Rose Gold crowns is being introduced, which looks more elegant and can be acceptable to the children. There are no studies comparing the parental satisfaction, child acceptance and clinical durability between Stainless steel crowns, Gold crowns and Rose gold crowns. Hence this study is conducted to comparative evaluation of parental satisfaction, patient acceptance and clinical success of stainless steel crown and titanium coated preformed primary crowns. |