| CTRI Number |
CTRI/2025/10/096572 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A cephalometric Analysis not relying on N point. |
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Scientific Title of Study
|
Sawangi Orthodontic Analysis (SOA) – A method of cephalometric evaluation for Angle’s class I, class II, and class III Malocclusion. |
| Trial Acronym |
|
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
Other |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajith kumar |
| Designation |
Post Graduate student |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Orthodontics and dentofacial orthopedics, No.102, first floor ,Sharad Pawar Dental College and Hospitals ,Sawangi ,Meghe .
Wardha
MAHARASHTRA
442001
India |
| Phone |
08610804754 |
| Fax |
|
| Email |
ajithraji375@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Narendra Sharma |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthodontics and dentofacial orthopedics, No.102, first floor ,Sharad Pawar Dental College and Hospitals ,Sawangi ,Meghe .
Wardha
MAHARASHTRA
442001
India |
| Phone |
08610804754 |
| Fax |
|
| Email |
sharmanarendra047@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajith kumar |
| Designation |
Junior Resident -2 |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Orthodontics and dentofacial orthopedics, No.102, first floor ,Sharad Pawar Dental College and Hospitals ,Sawangi ,Meghe .
Wardha
MAHARASHTRA
442001
India |
| Phone |
08610804754 |
| Fax |
|
| Email |
ajithraji375@gmail.com |
|
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Source of Monetary or Material Support
|
| Datta meghe institute of higher Education and research, Sharad Pawar dental college and hospital,Sawangi,Wardha. |
|
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Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAjith kumar |
Sharad Pawar Dental College and Hospitals |
Department of Orthodontics and dentofacial orthopedics, No.102, first floor , Hospitals ,Sawangi ,Meghe .
Wardha
MAHARASHTRA |
08610804754
ajithraji375@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ideal patients who can expose to (lateral cephalogram) x-ray |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Lateral cephalogram of Males and females with age of 7 to 15.
2. Lateral cephalogram of Males and females with age of 15 to 40.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy (especially the first trimester) – To avoid fetal exposure to radiation, unless absolutely necessary and with proper shielding.
2. Patients with neurological disorders, severe disabilities, or lack of cooperation (e.g.young children).
3. Patients with Radiation Sensitivity.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
Power of the Test: 80%
Study Design: Comparative study design(In vitro study)
Level of significance: 5%( 95% confidence interval)
Statistical Analysis:
Statistical analysis will be done by using descriptive and inferential statistics using Chisquare test, Student’s paired, unpaired t test, one way ANOVA, Tukey Test and software used in the analysis will be SPSS 27.0 version and GraphPad Prism 7.0 version and p0.05 is considered as level of significance.
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Assessment will be done by 4 weeks |
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Secondary Outcome
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| Outcome |
TimePoints |
| NIL |
NIL |
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Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="8"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ajithraji375@gmail.com].
- For how long will this data be available start date provided 28-09-2025 and end date provided 28-12-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
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Project Title Sawangi Orthodontic Analysis A Method of Cephalometric Evaluation for Angle s Class I Class II and Class III Malocclusion A Cross-Sectional Study
Investigator Dr Ajith Kumar MDS 1st year
Guide Dr Narendra Sharma Professor
Cephalometric analysis is a key diagnostic tool in orthodontics used to evaluate craniofacial growth and development as well as guide treatment planning For it to be effective should be precise reliable and reproducible. The traditional Steiner method (1953) employed the sella Nasion (SN) line as a reference plane but faced issues because the Nasion (N) point is unstable due to ongoing growth and remodeling at the junction of the frontal and nasal bones This instability can distort skeletal measurements such as SNA and SNB In contrast the Sella point stabilizes after about age six making it a more reliable landmark Another widely used approach the Wits appraisal measures jaw disharmony by projecting points A and B onto the occlusal plane While simpler it too suffers from limitations in reliability and accuracy Given these challenges a new method called Sawangi Orthodontic Analysis SOA has been proposed SOA excludes the unreliable Nasion point and instead evaluates skeletal dental and soft tissue relationships using parameters based on the more stable Sella point This aims to improve diagnostic accuracy in assessing malocclusions across Angle s Class I II and III categories It consisting of both linear and angular measurements and has new parameters excluding Nasion point
Study Focus The research proposes a new cephalometric analysis SOA that excludes the traditionally unstable Nasion poin instead relying on the Sella as a stable landmark
The aim is to achieve more precise evaluation of skeletal dental and soft tissue relationships in different classes of malocclusion
Objectives
Measure skeletal dental and soft tissue parameters using lateral cephalograms Establish mean values for these new parameters across Class I II and III malocclusion cases
Methodology
Cross-sectional study of 160 patients (divided into two age groups 7–15 years and 15–40 years with equal male and female representation) Lateral cephalograms will be analyzed with newly defined linear and angular measurements. The mean value obatained after calculating it based on the parameters final value obtained as Inference would be used .Again final mean value will be calculated between two groups. Final values would be used as an Inference for this study. Statistical analysis with Chi-square t-tests ANOVA and Tukey tests SPSS and GraphPad Prism
Scope and Expected Outcome
Provides an alternative to Steiner and Wits analyses by avoiding unreliable landmarks Anticipated to yield more accurate diagnosis and treatment planning for malocclusions.
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