| CTRI Number |
CTRI/2025/08/092196 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative evaluation of clinical success of stainless steel and Edelweiss crowns in primary molar.-An in vivo study. |
|
Scientific Title of Study
|
Comparative evaluation of clinical success of stainless steel and edelweiss crowns in primary molar - 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 |
Kumari Nandani |
| Designation |
Post Graduate Student |
| Affiliation |
Surendera dental college and research institute |
| Address |
Department of paediatric and preventive dentistry, Surendera dental college and research institute, his highness garden, sriganganagar, Rajasthan.
Ganganagar
RAJASTHAN
335001
India |
| Phone |
9279934825 |
| Fax |
|
| Email |
kn15101998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suruchi Juneja Sukhija |
| Designation |
Professor and head |
| Affiliation |
Surendera dental college and research institute |
| Address |
Department of paediatric and preventive dentistry, Surendera dental college and research institute, his highness garden, sriganganagar, Rajasthan.
Ganganagar
RAJASTHAN
335001
India |
| Phone |
9829365880 |
| Fax |
|
| Email |
drsuruchijuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kumari Nandani |
| Designation |
Post Graduate Student |
| Affiliation |
Surender dental college and research institute |
| Address |
Department of paediatric and preventive dentistry, Surendera dental college and research institute, his highness garden, sriganganagar, Rajasthan.
Ganganagar
RAJASTHAN
335001
India |
| Phone |
9279934825 |
| Fax |
|
| Email |
kn15101998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of paediatric and preventive dentistry, Surendera dental college and research institute, his highness garden, powerhouse road,sriganganagar, Rajasthan. |
|
|
Primary Sponsor
|
| Name |
Kumari Nandani |
| Address |
Department of paediatric and preventive dentistry, Surendera dental college and research institute, his highness garden, sriganganagar, Rajasthan. |
| 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 |
| Kumari Nandani |
Surendera dental college and research institute |
Department of paediatric and preventive dentistry, Surendera dental college and research institute, his highness garden, sriganganagar, Rajasthan.
Ganganagar
RAJASTHAN |
9279934825
kn15101998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SURENDERA DENTAL COLLEGE & RESEARCH INSTITUTE ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient opting regular dental treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Edelweiss crown |
Edelweiss crown is placed following completion of the obturation procedure of tooth. |
| Comparator Agent |
stainless steel crown |
stainless steel crown is placed following completion of the obturation procedure of tooth. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children with at least two primary molars indicated for pulpectomy. Children aged between 3 to 8 years. Teeth with at least 50% of tooth structure intact, functioning in occlusion with an opposing tooth. Healthy children free of any systemic diseases.
|
|
| ExclusionCriteria |
| Details |
• Children with special health needs.
• Severely decayed primary molars prohibiting the retention and the sealing of the restoration.
• Inadequate root length.
• The child allergic to local anesthesia, chromium or nickel.
• Teeth that have been subjected to trauma.
• Teeth with preshedding mobility.
• Teeth with more than one third root resorption
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical effectiveness of Edelweiss crowns in comparison to Stainless Steel crowns, focusing on anatomical form, marginal adaptation, marginal discoloration, secondary caries, plaque accumulation, retention, and gingival response. |
1,3,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical effectiveness of Edelweiss crowns in comparison to Stainless Steel crowns, focusing on anatomical form, marginal adaptation, marginal discoloration, secondary caries, plaque accumulation, retention, and gingival response. |
1,3,6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study involves placing two types of crowns on both the left and right primary molars of patients, aged 3 to 8 years who are willing to participate. Compare the Edelweiss crowns and Stainless Steel crowns in terms of anatomical form, marginal adaptation, marginal discoloration, secondary caries, plaque accumulation, retention, and gingival response, with follow-ups at 1, 3, and 6 months.. |