| CTRI Number |
CTRI/2026/03/106624 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
a comparative study of hand tracing and computer generated tracing among participants undergoing orthodontic intervention |
|
Scientific Title of Study
|
comparative evaluation of measurements by manual versus digital software generated cephalometric tracing |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjana Baisoya |
| Designation |
Postgradute resident |
| Affiliation |
Kalka Dental College |
| Address |
Department of orthodontics and dentofacial orthopaedics
Kalka dental College
Meerut partapur bypass
Department of orthodontics and dentofacial orthopaedics
Kalka dental College
Meerut partapur bypass
Meerut
UTTAR PRADESH
250103
India |
| Phone |
9870128297 |
| Fax |
|
| Email |
baisoyasanjana699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shipra nagar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Kalka Dental College |
| Address |
Department of orthodontics and dentofacial orthopaedics
Kalka dental College
Meerut partapur bypass
Department of orthodontics and dentofacial orthopaedics
Kalka dental College
Meerut partapur bypass
Meerut
UTTAR PRADESH
250103
India |
| Phone |
9971822949 |
| Fax |
|
| Email |
shipray@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shipra Nagar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Kalka dental College |
| Address |
Department of orthodontics and dentofacial orthopaedics
Kalka dental College
Meerut partapur bypass
Department of orthodontics and dentofacial orthopaedics
Kalka dental College
Meerut partapur bypass
Meerut
UTTAR PRADESH
250103
India |
| Phone |
9971822949 |
| Fax |
|
| Email |
shipray@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kalka Dental college |
| Address |
Partapur bypass Meerut Uttar Pradesh India
Pincode 250103 |
| Type of Sponsor |
Research institution |
|
|
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 Shipra Nagar |
Kalka dental College |
Department of orthodontics and dentofacial orthopaedics Room No 9
Meerut partapur bypass
Pincode 250103
Meerut
UTTAR PRADESH |
9870128297
shipray@yahoo.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: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digital software generated cephalometric tracing |
Digital software generated cephalometric tracing using nemoceph and autoCeph software at baseline (T0) and at 4 week (T1) |
| Comparator Agent |
Manual cephalometric tracing versus digital cephalometric tracing |
Manual cephalometric tracing versus digital cephalometric tracing using nemoceph and autoceph software at baseline (T0) and at 4 week (T1) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects seeking orthodontic treatment whose records included cephalometric Xrays
Age group 18 to 45 years
Patients with normal growth and development
|
|
| ExclusionCriteria |
| Details |
patient having previous history of trauma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the accuracy of manual and computer software generated cephalometric measurements |
At Baseline (T0) collection of cephalometric images (pre-tracing)
first Repeat at (T1) after time duration of 4 Weeks to assess the reproducibility of measurement over the time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/04/2026 |
| 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="4" |
|
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 - 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
- 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 [baisoyasanjana699@gmail.com].
- For how long will this data be available start date provided 21-11-2026 and end date provided 21-06-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title Comparative evaluation of manual versus software-generated digital cephalometric analysis. Background Cephalometric analysis plays a vital role in orthodontic diagnosis and treatment planning. Manual tracing has traditionally been considered the gold standard but is time-consuming and prone to operator variability. With digital advancements, software-generated cephalometric analysis has become popular; however, its accuracy compared with manual tracing remains debatable. Aim To comparatively evaluate cephalometric measurements obtained through manual tracing and software-generated digital cephalometric analysis. Materials and Methods This comparative cross-sectional study was conducted on 50 lateral cephalometric radiographs. Each radiograph was subjected to: 1. Manual tracing, 2. Digital analysis using Software A- Nemoceph 3. Digital analysis using Software B-Autoceph. Skeletal, dental, and soft-tissue parameters were recorded. Shapiro–Wilk test assessed normality. Paired t-test/Wilcoxon test compared methods. Intraclass correlation coefficient assessed reliability. Agreement was evaluated using Bland–Altman analysis. Significance was set at p < 0.05. |