| CTRI Number |
CTRI/2025/02/080027 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of gum health and clinical success of stainless steel crown, zirconia and edelweiss crowns in milk teeth : A randomised clinical trial |
|
Scientific Title of Study
|
A comparative evaluation of periodontal health and clinical success of prefabricated stainless steel crown, zirconia and edelweiss crowns in primary molars : A randomised 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. Rajeev kumar singh |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
New dental building kgmu shah mina road chowk lucknow uttar pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9450849528 |
| Fax |
|
| Email |
rajkids2000@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mayank Goel |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
New Dental Building FODS KGMU Shah Mina road Chowk Lucknow 226003
Lucknow UTTAR PRADESH 226003 India |
| Phone |
8948406288 |
| Fax |
|
| Email |
goelmayank781@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajeev Kumar Singh |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
New Dental Building KGMU Shah Mina road Chowk Lucknow 226003
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9450849528 |
| Fax |
|
| Email |
rajkids2000@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KING GEORGES MEDICAL UNIVERSITY, Lucknow Uttar Pradesh India 226003 |
|
|
Primary Sponsor
|
| Name |
Dr Rajeev Kumar Singh |
| Address |
FODS, Department of paediatric and preventive dentistry KGMU Lucknow Uttar pradesh - 226003 |
| Type of Sponsor |
Other [Other [self funded]] |
|
|
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 Rajeev kumar singh |
Faculty Of Dental Sciences |
4th floor, New Dental Building, Department of
paediatric and preventive dentistry, Faculty Of Dental
Sciences, King Georges Medical
University,Chowk, Lucknow Uttar Pradesh -226003 Lucknow UTTAR PRADESH |
9450849528
rajkids2000@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K085||Unsatisfactory restoration of tooth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Edelweiss Crown |
After completion of pulpectomy in primary molar teeth edelweiss crown will be placed according to manufacturer instructions. Follow up of 1 year will be taken. |
| Comparator Agent |
Stainless steel crown |
After completion of pulpectomy in primary molar tooth stainless steel crown will be placed according to manufacturer instructions. follow up of 1 year will be taken |
| Intervention |
Zirconia Crown |
After completion of pulpectomy in primary molar tooth zirconia crown will be placed according to manufacturer instructions.Follow up of will be taken for 1 year |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 4 to 9 years, indicated for pulpectomy followed by full coverage restoration.
2.Healthy cooperative children free of any systemic ailment or any developmental disturbances of the teeth and jaws that would affect patient’s diet, caries susceptibility or the selection of restorative material.
3.Presence of antagonist tooth, willingness to participate in the study and to continue with the follow-up appointments.
4.Teeth with more than two-third of the root length.
|
|
| ExclusionCriteria |
| Details |
1.Teeth with internal resorption
2.Teeth with physiologic root resorption more than one-third of the root length
3.Teeth that are non-restorable
4.Patients with compromised general health due to systemic disease
5.Excessive hemorrhage encountered during the clinical procedure
6.Exposures with purulent discharge or serous exudate |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Clinical success assessment criteria for each crown as retention.
2.periodontal health assessment |
At baseline (T0)
At one month (T1)
At three month (T2)
At six month (T3)
At twelve month (T4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parental Satisfaction |
At baseline (T0)
At one month (T1)
At three month (T2)
At six month (T3)
At twelve month (T4) |
|
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
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)
|
20/02/2025 |
| 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="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
|
For children’s overall development, maintaining a healthy primary
dentition is crucial. Three crucial factors are preservation of tooth
structure, restorative durability, and parental satisfaction. In paediatric
dentistry, several methods for full-coverage restorations have been developed.Aim is to evaluate and compare the
clinical success and periodontal health of children after restoring primary
molars with stainless steel crown or zirconia crown or edelweiss pediatric
crown (edelweiss dentistry ®) using plaque index(PI) and gingival index(GI) and
simplified oral health index(OHI -S) at one,three,six &twelve month interval.The present study is a randomised
controlled clinical trial which will be conducted in the Department of
Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King George’s
Medical University in Lucknow, Uttar Pradesh.. All patients will be
selected after obtaining detailed history and thorough clinical examination. All children had at least
one decayed primary molar teeth requiring full coverage restoration and an
antagonist tooth and met the remaining inclusion criteria: willingness to
participate in the study and to continue with the follow-up appointments.Before
beginning their treatments, children, along with their parents, received a
standard oral hygiene education, which consisted of a brushing demonstration by
a postgraduate dental student on a model only once.Throughout the follow-ups,
parents were warned when signs of gingival inflammation were present or plaque
control was inadequate.The data for each tooth will be
recorded on individual data record sheet. The final data will be transferred to
master data sheet. The data thus obtained will be subjected to statistical
analysis |