| 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
|
|
|
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
|
|
|
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. |