| CTRI Number |
CTRI/2024/03/064802 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on new cartoon printed stainless steel cap on the milk teeth of the children. |
|
Scientific Title of Study
|
Evaluation of behaviour and acceptance of child towards novel laser cartoon printed stainless steel crown verses conventional stainless steel crown- A randomized clinical trial. |
| 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 Avani Ramesh Doiphode |
| Designation |
Postgraduate Student |
| Affiliation |
Government Dental College and Hospital, Nagpur. |
| Address |
Room No - 108, Department of Paediatric and Preventive Dentistry, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.
Nagpur MAHARASHTRA 440003 India |
| Phone |
9075725395 |
| Fax |
|
| Email |
avanidoiphode5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ritesh Kalaskar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Room NO- 108, Department of Paediatric and Preventive Dentistry, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.
Nagpur MAHARASHTRA 440003 India |
| Phone |
8550938585 |
| Fax |
|
| Email |
riteshpedo@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Avani Ramesh Doiphode |
| Designation |
Postgraduate Student |
| Affiliation |
Government Dental College and Hospital, Nagpur. |
| Address |
Room no - 108, Department of Paediatric and Preventive Dentistry, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.
Nagpur MAHARASHTRA 440003 India |
| Phone |
9075725395 |
| Fax |
|
| Email |
avanidoiphode@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Nagpur. |
|
|
Primary Sponsor
|
| Name |
Dr Avani Ramesh Doiphode |
| Address |
Swamiraj Niwas, At post-Varse, Tal-Roha, Dist-Raigad, Maharashtra, India. |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Avani Ramesh Doiphode |
Government Dental College and Hospital, Nagpur. |
Room No- 108, Department of Paediatric and Preventive Dentistry. Nagpur MAHARASHTRA |
9075725395
avanidoiphode5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K042||Pulp degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Stainless steel crown |
Conventional stainless steel crowns are most commonly used to restore the deciduous teeth in children. These stainless steel crowns are available as pre fabricated crowns that are ready to use. These crowns have metallic silver colour appearance. |
| Intervention |
Laser Cartoon Printed Stainless Steel Crown |
The conventional stainless steel crown was modified by printing cartoon characters on the surface using the laser printing technique so that the children will get attracted to the cartoon present on the stainless steel crown and will cooperate while placing the crowns on the teeth. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1-Healthy children between 4 to 8 years of age
2-Bilateral primary first and second molars requiring pulpectomy procedure
|
|
| ExclusionCriteria |
| Details |
1-Primary mandibular molars indicated for extraction.
2-Children with ASA physical status ≥ III, systemic illness, highly uncooperative children.
3-Children with very poor oral hygiene.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Behaviour of children |
Behaviour of children before and during placement of laser cartoon printed stainless steel crown and conventional stainless steel crown will be assessed at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceptance of children towards novel laser cartoon printed stainless steel crown |
After placement of the laser cartoon printed stainless steel crown & conventional stainless steel crown the outcome will be assessed at baseline. |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="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
|
A stainless steel crown (SSC) is a pre-fabricated metallic tooth-shaped crown that fits over the remaining tooth structure to protect the tooth from further breakdown. SSC is most commonly used to restore the form and function of severely damaged and decayed teeth. They are used extensively in the primary dentition. The cooperation of pediatric patients is important for any successful treatment in pediatric dentistry. Before or during treatment patients’ behavior needs to be modified using various behavior management techniques. Lack of cooperation during the placement of SSC has been identified as one of the major factors for improper placement of SSC. As we know children’s are very fond of cartoons and there is always a positive relation seen between the attractiveness of objects and children’s attitude towards them. Till date, no technique has been developed using SSC that can modify or influence the behavior of a child. To reduce anxiety and to gain the cooperation of the child while placement of SSC, we will laser print a cartoon and the name of a child on SSC. The pictures/ cartoon will be customized according to the child’s wish and will be printed on the SSC. Also, the name of the child can be printed on SSC which can be helpful for forensic purposes too. This novel printed SSC will be more attractive and pleasing to the patient when compared with the conventional SSC. There will be the active involvement of a child in process of selecting pictures, cartoon, or their name also. This novel method will positively influence the child’s attitude toward the treatment. |