| CTRI Number |
CTRI/2025/05/087486 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Accuracy of 3D Printed Dental Models and Digital Scans Using Straight-Line Measurements of the Full Set of Teeth. |
|
Scientific Title of Study
|
Accuracy Of 3D Scanned Full Arch Dentition Versus 3D Printed Models Generated From Various 3D Printers Using Linear Measurements |
| 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 Soorabathula sonika mani kiran |
| Designation |
Post graduate student |
| Affiliation |
GSL DE NTAL COLLEGE AND HOSPITAL |
| Address |
Dept. of Orthodontics and Dentofacial orthopaedics,Room no.9,GSL Dental college and hospital,Lakshmipuram,Rajahmundry,Andhra Pradesh
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9515860858 |
| Fax |
|
| Email |
soorabathula.sonika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S V M Raghuram Ravipati |
| Designation |
Professor and HOD |
| Affiliation |
GSL DE NTAL COLLEGE AND HOSPITAL |
| Address |
Dept. of Orthodontics and Dentofacial orthopaedics,Room no.9,GSL Dental college and hospital,Lakshmipuram,Rajahmundry,Andhra Pradesh
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9618060003 |
| Fax |
|
| Email |
rsvmrr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S V M Raghuram Ravipati |
| Designation |
Professor and HOD |
| Affiliation |
GSL DE NTAL COLLEGE AND HOSPITAL |
| Address |
Dept. of Orthodontics and Dentofacial orthopaedics,Room no.9,GSL Dental college and hospital,Lakshmipuram,Rajahmundry,Andhra Pradesh
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9618060003 |
| Fax |
|
| Email |
rsvmrr@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSL DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr Soorabathula sonika mani kiran |
| Address |
Dept. of orthodontics and dentofacial orthopaedics,Room no.9,GSL Dental college and hospital,Lakshmipuram,Rajahmundry-533296,Andhra Pradesh. |
| 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 Soorabathula sonika mani kiran |
GSL DENTAL COLLEGE AND HOSPITAL |
Dept. of Orthodontics and Dentofacial orthopaedics,Room no.9,GSL Dental college and hospital,Lakshmipuram,Rajahmundry,Andhra Pradesh-533296
East Godavari
ANDHRA PRADESH |
9515860858
soorabathula.sonika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSL DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MALOCCLUSION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.No history of orthodontic treatment.
2.All fully erupted permanent teeth in the mandibular arch, excluding the third molars.
|
|
| ExclusionCriteria |
| Details |
1.Missing teeth in both the arches.
2.Morphological alterations of tooth that could impact the accuracy of the measurements.
3.Decayed teeth, root canal treated teeth, restorations, prosthesis, and fractured teeth.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of measurements |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra examiner reliability
interchangeability and acceptance |
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
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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="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
|
PURPOSE OF THE STUDY: The primary purpose of the study is to assess the accuracy of dental measurements obtained from 3D printed models generated from various 3 and |