| CTRI Number |
CTRI/2025/07/092010 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the success of different types of crowns—pre-formed zirconia, custom-made zirconia, and resin crowns—used on childrens teeth after root canal treatment |
|
Scientific Title of Study
|
A randomized controlled trial to evaluate clinical performance of pre-formed zirconia crowns, CAD/CAM zirconia crowns and pre-formed resin polymer crowns in primary molars post endodontic therapy
|
| 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 Nidhi Gupta |
| Designation |
Professor and Head |
| Affiliation |
Santosh Dental College and hospital, Ghaziabad |
| Address |
Santosh Dental college and hospital, 1, Santosh nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh 201009
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
9810358916 |
| Fax |
|
| Email |
nid_gup6@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rishabh Solanki |
| Designation |
Post Graduate |
| Affiliation |
Santosh Dental College and hospital, Ghaziabad |
| Address |
Santosh Dental college and hospital, 1, Santosh nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh 201009
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
9599644129 |
| Fax |
|
| Email |
rsolanki9313@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Gupta |
| Designation |
Professor and Head |
| Affiliation |
Santosh Dental College and hospital, Ghaziabad |
| Address |
Santosh Dental college and hospital, 1, Santosh nagar, Sector 12, Block H, Pratap Vihar, Ghaziabad, Uttar Pradesh 201009
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
9810358916 |
| Fax |
|
| Email |
nid_gup6@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Santosh Dental college and Hospital, Ghaziabad |
|
|
Primary Sponsor
|
| Name |
Dr Rishabh Solanki |
| Address |
Department of pediatric and preventive dentistry, santosh dental college and hospital, santosh university, 1, santosh nagar, sector 12, block H, pratap vihar, Ghaziabad |
| 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 Nidhi Gupta |
Santosh dental college and hospital |
Department of Paediatric and Preventive dentistry
Ghaziabad
UTTAR PRADESH |
09810358916
nid_gup6@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Santosh University institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CADCAM crown |
these crown provide precise fit and more aesthetic and are designed digitally. time duration is of 1 month follow up |
| Intervention |
Pre formed resin polymer crowns |
Pre formed resin polymer crowns are the newly introduced crown in pediatric dentistry composed of polymethylmetaacrylate. time duration is of 1 month follow up |
| Comparator Agent |
preformed zirconia crown |
introduced in year 2008. preformed zirconia crowns are aesthetic crowns and durable but they require more tooth reduction. time duration is of 1 month followup |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy children
Age range 5-10 years old
Co-operative child
Endodontic treated primary mandibular molars |
|
| ExclusionCriteria |
| Details |
More than 1/3 of root resorption is present
Presence of abscess in primary mandibular molars indicated for extraction
Presence of mobility in primary mandibular molars
No Parental consent
Tooth with pre-shedding and abnormal pathological mobility
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Crown Retention – Assessment of crown stability and dislodgement.
Marginal Integrity – Evaluation of crown fit and marginal adaptation.
Gingival Health – Monitoring of gingival response around crowns.
Color Stability – Assessment of discoloration or staining over time.
|
Crown Retention – Assessment of crown stability and dislodgement.
Marginal Integrity – Evaluation of crown fit and marginal adaptation.
Gingival Health – Monitoring of gingival response around crowns.
Color Stability – Assessment of discoloration or staining over time.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
11/08/2025 |
| 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="0"
Months="2"
Days="10" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rsolanki9313@gmail.com].
- For how long will this data be available start date provided 30-07-2025 and end date provided 15-09-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The
Pre-formed polymer
crowns
are
new to Indian market and can change scenario of pediatric dentistry as they are
formed by high strength
resin polymer used in the medical device industry in applications requiring
high strength, flexibility and durability
and cost effective. Bis-GMA
is absent in these crowns.
Bis-GMA
contains Bisphenol A which is linked to have harmful effect on brain and
increase risk of cardiovascular disease.
No BisGMA
in it
makes
them safe for the growing child’s mental health. |