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CTRI Number  CTRI/2025/04/084412 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 04/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of SOS Fusion and Cervical Vertebral Maturation for Predicting Mandibular Growth in Adolescents (12-18 Years): An Observational Study 
Scientific Title of Study   Comparative Evaluation of Spheno-Occipital Synchondrosis Fusion and Cervical Vertebral Maturation Index in Predicting Mandibular Peak Growth in Adolescent (Aged 12-18 Years): An Observational 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  Dr, Akshata Awachat 
Designation  Post Graduate Student 
Affiliation  RANJEET DEKHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR 
Address  Room no. 110, 1st floor, Department of Orthodontics and Dentofacial Orthopaedics, Ranjeet Deshmukh Dental College and Research Centre, Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  08554916649  
Fax    
Email  awachat24akshata@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ananya Hazare 
Designation  Associate Professor 
Affiliation  RANJEET DEKHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR 
Address  Room no. 110, 1st floor, Department of Orthodontics and Dentofacial Orthopaedics, Ranjeet Deshmukh Dental College and Research Centre, Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  9890992170  
Fax    
Email  ananya.hazare@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Akshata Awachat 
Designation  Post Graduate Student 
Affiliation  RANJEET DEKHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR 
Address  Room no. 110, 1st floor, Department of Orthodontics and Dentofacial Orthopaedics, Ranjeet Deshmukh Dental College and Research Centre, Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  08554916649  
Fax    
Email  awachat24akshata@gmail.com  
 
Source of Monetary or Material Support  
Ranjeet Deshmukh Dental College and Research Centre, Nagpur - 440019, State: Maharashtra, Country: India. 
 
Primary Sponsor  
Name  Dr Akshata Awachat 
Address  Room no. 110, 1st floor, Department of Orthodontics and Dentofacial Orthopaedics, Ranjeet Deshmukh Dental College and Research Centre, Nagpur. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshata Awachat  Ranjeet Deshmukh Dental College and Research Centre, Nagpur.  Room no. 110, 1st floor, Department of Orthodontics and Dentofacial Orthopaedics, Ranjeet Deshmukh Dental College and Research Centre, Nagpur.
Nagpur
MAHARASHTRA 
08554916649

awachat24akshata@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE VSPM DCRC, NAGPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Only having dental malocclusion and requiring treatment for correction of their dental problems  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Oral assent from subjects and written consent from parents/Guardian willing to participate in
the study.
2. Patients aged between 12 and 18 years.
3. Patients having no pathological fracture or trauma.
4. Patients having CBCT scans taken for orthodontic treatment. 
 
ExclusionCriteria 
Details  1. Lack of informed consent from participants or guardians.
2. Patients with history of orthodontic treatment.
3. Congenital or acquired abnormalities (e.g., cleft lip/palate).
4. Conditions such as hypothyroidism, growth hormone deficiency and any
abnormalities. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. To Evaluate the accuracy of Spheno-Occipital Synchondrosis (SOS) fusion stages in predicting
mandibular peak growth in Adolescent aged 12-18 years.
2. To Evaluate the accuracy of Cervical Vertebral Maturation Index (CVMI) in predicting
mandibular peak growth in Adolescent aged 12-18 years.

3. Compare the accuracy of Spheno-Occipital Synchondrosis (SOS) fusion stages and Cervical
Vertebral Maturation Index (CVMI) in predicting mandibular peak growth in Adolescent aged
12-18 years. 
withiin 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To investigate the gender-based differences in the correlation between SOS fusion stages,
CVMI, & mandibular peak growth.
2. To explore the impact of SOS fusion stages & CVMI on the timing of mandibular growth
spurts in different age subgroups 12-15 years (Early Adolescent) & 15-18 years (Late
Adolescent). 
within 18 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   21/08/2025 
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="1"
Months="5"
Days="30" 
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  

This study focuses on developing a new method for assessing mandibular peak growth using the Spheno-Occipital Synchondrosis (SOS), a potentially more accurate and reliable alternative to the existing gold standard, the Cervical Vertebral Maturation Index (CVMI). While CVMI is commonly used in orthodontics to evaluate the timing of mandibular growth, its accuracy can be influenced by individual patient variations, leading to inconsistencies in treatment planning.

The research aims to establish SOS as a new and more precise marker for mandibular growth by utilizing CBCT scans to evaluate the synchondrosis. By comparing the results with CVMI, the study will determine if SOS offers enhanced predictability and better outcomes for orthodontic treatment. The investigation will be conducted at the Department of Orthodontics and Dentofacial Orthopaedics, Ranjeet Deshmukh Dental College and Research Centre, Nagpur, in collaboration with the Department of Oral Medicine and Radiology.

The primary objective of this research is to validate SOS as an innovative tool for assessing mandibular growth, which could help orthodontists create more individualized treatment plans. If successful, the SOS method could replace or supplement CVMI, offering a more accurate, consistent, and biologically informed approach to growth prediction.

This study aims to contribute to the advancement of orthodontic practice by providing a refined methodology for evaluating mandibular growth, potentially improving diagnosis, treatment timing, and overall patient care.

 
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