| CTRI Number |
CTRI/2025/07/090414 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [comparative] |
| Study Design |
Other |
|
Public Title of Study
|
comparision of the accuracy in between dental stone cast and 3Dprinted cast |
|
Scientific Title of Study
|
Comparison Of The Accuracy Of Three Dimensional Printed Cast And Conventional Cast In Class I Molar Relationship- 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 |
Sanjeev K Shokeen |
| Designation |
Post Graduate |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
department of orthodontics and dentofacial orthopaedics TF 2 THIRD FLOOR 46-1 Site-IV INDUSTRIAL AREA SAHIBABAD GHAZIABAD UTTAR PRADESH
department of orthodontics and dentofacial orthopaedics TF 2 THIRD FLOOR 46-1 Site-IV INDUSTRIAL AREA SAHIBABAD GHAZIABAD UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9650948087 |
| Fax |
|
| Email |
sanjeevshokeen74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Paul |
| Designation |
principal,professor and head of the department |
| Affiliation |
Inderprastha dental college and hospital |
| Address |
inderprastha dental college and hospital department of orthodontics and dentofacial orthopaedics TF 2 THIRD FLOOR 46-1 Site-IV INDUSTRIAL AREA SAHIBABAD GHAZIABAD UTTAR PRADESH
inderprastha dental college and hospital department of orthodontics and dentofacial orthopaedics TF 2 THIRD FLOOR 46-1 Site-IV INDUSTRIAL AREA SAHIBABAD GHAZIABAD UTTAR
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9650948087 |
| Fax |
|
| Email |
Drrahulpaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeev K Shokeen |
| Designation |
post graduation |
| Affiliation |
inderprastha dental college and hospital |
| Address |
inderprastha dental college and hospital department of orthodontics and dentofacial orthopaedics TF 2 THIRD FLOOR 46/1 Site-IV INDUSTRIAL AREA SAHIBABAD GHAZIABAD UTTAR PRADESH
inderprastha dental college and hospital department of orthodontics and dentofacial orthopaedics TF 2 THIRD FLOOR 46/1 Site-IV INDUSTRIAL AREA SAHIBABAD GHAZIABAD UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9650948087 |
| Fax |
|
| Email |
sanjeevshokeen74@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No-2,Third Floor,Department of Orthodontics and Dentofacial Orthopaedics ,Inderprastha Dental College And Hospital
46-1 Site IV Industrial Area
Sahibabad
Ghaziabad
Uttar Pradesh -201010 |
|
|
Primary Sponsor
|
| Name |
Dr. Sanjeev K Shokeen |
| Address |
Room No-2,Third Floor,Department of Orthodontics and Dentofacial Orthopaedics ,Inderprastha Dental College And Hospital
46-1 Site IV Industrial Area
Sahibabad
Ghaziabad
Uttar Pradesh -201010
|
| 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 |
| Sanjeev K Shokeen |
Inderprastha dental college and hospital |
Department of orthodontics and dentofacial orthopaedics
46-1 Site -IV Industrial area
Sahibabad Ghaziabad
Uttar pradesh
201010
Ghaziabad
UTTAR PRADESH |
9650948087
sanjeevshokeen74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3-D printed cast |
compare the accuracy of linear measurements of three-dimensional printed cast and conventional cast with intra-oral in Class I molar relationship |
| Comparator Agent |
conventional cast |
compare the accuracy of linear measurements of three-dimensional printed cast and conventional cast with intra-oral in Class I molar relationship |
| Comparator Agent |
Intra-Oral |
control for comparing the accuracy of linear measurements of three-dimensional printed cast and conventional cast with intra-oral in Class I molar relationship |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age group more then 14 years
Presence of first permanent molars
Presence of permanent canine
Presence of first premolar
Presence of second premolar
No history of systemic disease
No history of allergy
Class I molar relationship
|
|
| ExclusionCriteria |
| Details |
Class II molar relationship
Class III molar relationship
History of allergy
History of systemic disease
Absence of first permanent molar
Absence of permanent canine
Absence of first premolar
Absence of second premolar
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| accuracy of linear measurements of three-dimensional printed cast and conventional cast with intra-oral in Class I molar relationship |
At T0(Baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the accuracy of linear measurements of three-dimensional printed cast & conventional cast with intra-oral in Class I molar relationship in mesio-distal & occluso-gingival |
At T0(Baseline) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2025 |
| Date of Study Completion (India) |
27/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
| AIM OF THE STUDY: o To compare the accuracy of linear measurements of three-dimensional printed cast and conventional cast to the intra-oral subjects in Class I molar relationship. OBJECTIVE OF THE STUDY: o To evaluate the linear measurements of three-dimensional printed cast in Class I molar relationship. o To evaluate the linear measurements of conventional cast in Class I molar relationship. o To evaluate the linear measurements intra-orally in Class I molar relationship. o To compare the accuracy of linear measurements of three-dimensional printed cast and conventional cast with intra-oral in Class I molar relationship NULL HYPOTHESIS: The accuracy in linear measurements of three-dimensional printed cast , conventional cast and intra-orally in Class I molar relationship is same. |
|