| CTRI Number |
CTRI/2023/09/057228 [Registered on: 04/09/2023] Trial Registered Prospectively |
| Last Modified On: |
02/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Retrospective study |
| Study Design |
Other |
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Public Title of Study
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Development of Artificial Intelligence based program to assess the level of maturation of bone and to detect any abnormalities in the upper spine by using head x-rays (side view) of children having cleft, that is, split in the upper lip and palate.
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Scientific Title of Study
|
Artificial Intelligence Based Algorithm For Assessment of Skeletal Age and Detection of Cervical Vertebral Anomalies in Lateral Cephalogram in Children with Cleft Lip and Palate |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaithoiliu Kamei |
| Designation |
Post graduate student |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE FARIDABAD |
| Address |
Manav Rachna Dental College, Sector 43, Delhi Surajkund Road, Aravalli Hills, Faridabad, Haryana
Sector 43, Delhi Surajkund Road, Aravalli Hills, Faridabad, Haryana- 121004
Faridabad
HARYANA
121004
India |
| Phone |
08448709604 |
| Fax |
|
| Email |
drthoikamei@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Puneet Batra |
| Designation |
Principal and Head of Department (HOD) |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE FARIDABAD |
| Address |
Manav Rachna Dental College, Sector 43, Delhi Surajkund Road, Aravalli Hills, Faridabad, Haryana
Sector 43, Delhi Surajkund Road, Aravalli Hills, Faridabad, Haryana- 121004
Faridabad
HARYANA
121004
India |
| Phone |
09810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaithoiliu Kamei |
| Designation |
Post graduate student |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE FARIDABAD |
| Address |
Manav Rachna Dental College, Sector 43, Delhi Surajkund Road, Aravalli Hills, Faridabad, Haryana
Sector 43, Delhi Surajkund Road, Aravalli Hills, Faridabad, Haryana- 121004
Faridabad
HARYANA
121004
India |
| Phone |
08448709604 |
| Fax |
|
| Email |
drthoikamei@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics, Room no. 3, Ground floor, Gate no. 9, Manav Rachna International Institute of Research and Sciences |
|
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Primary Sponsor
|
| Name |
Gaithoiliu Kamei |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room no.3, Ground floor, Gate no. 9, Manav Rachna Dental College, Faridabad, Haryana. |
| Type of Sponsor |
Other [SELF] |
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Details of Secondary Sponsor
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|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaithoiliu Kamei |
Manav Rachna Dental College |
Department of Orthodontics & Dentofacial Orthopedics, Room no. 3, Ground floor, Gate no. 2, Manav Rachna Dental College, Sector 43, Delhi Surajkund Road, Aravalli Hills, faridabad, Haryana- 121004
Faridabad
HARYANA |
08448709604
drthoikamei@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q378||Unspecified cleft palate with bilateral cleft lip, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having cleft lip and palate without any associated syndromes, congenital disorders, previous history of trauma/ illness. |
|
| ExclusionCriteria |
| Details |
Individuals who are not age-matched with the inclusion criteria.
Individuals having cleft lip and palate associated with any associated syndromes, congenital disorders, previous history of trauma/ illness.
Individuals with systemic diseases affecting bone density. |
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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
|
| Outcome |
TimePoints |
| To be able to detect & compare skeletal age in cleft & non cleft patients |
One year |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To accurately detect anomalies in the cervical vertebrae in cleft & non cleft patients |
1 year |
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Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
10/09/2023 |
| 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="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
In this study, 1000 lateral cephalograms (head x-rays) will be collected to develop a machine learned program which will assess the upper spine and detect the maturity of the bone utilizing the Cervical Vertebral Maturation (CVM) method. The benefit of choosing lateral cephalograms is the prevention of additional radiation exposure to the patients as it is a routine orthodontic diagnostic radiograph. additionally, the program can detect any abnormalities in the morphology of the upper spine deviating from the normal.
The correction of disharmonies in the sagittal, transverse, and vertical planes, orthodontic therapy and interventions are often timed to occur before or during the pubertal growth spurt or peak of growth velocity. Therefore, the thorough understanding of the timing of the craniofacial growth and development and skeletal age is critical in the correct diagnosis, treatment planning, outcome and overall stability of orthodontic treatment, secondary alveolar bone grafting, and orthognathic surgery in CL/P children.
Assessment of skeletal age using the CVM method is usually performed by orthodontists and other dental specialists and is a tedious procedure with variations in reproducibility and is subjective, leading to inaccuracies in results.
Therefore, the efficiency of outcome measurements as well as the predictability and reliability of the results will be considerably improved by the use of artificial intelligence-based models for automatic skeletal age detection in lateral cephalograms. This may be helpful where there is a lack of medical resources because automated technologies can speed up medical care and provide accurate and prompt diagnosis.
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