| CTRI Number |
CTRI/2024/08/072321 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of an Artificial Intelligence (AI) model to predict changes with a removable functional appliance in growing children |
|
Scientific Title of Study
|
Artificial Intelligence (AI) based assessment and prediction for outcomes of Twin Block appliance therapy in growing patients having Class II malocclusion |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Duggal |
| Designation |
Senior Research Associate |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Orthodontics, Maulana Azad Institute of Dental Sciences
New Delhi
DELHI
110002
India |
| Phone |
9810161413 |
| Fax |
|
| Email |
ishaduggal.91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Isha Duggal |
| Designation |
Senior Research Associate |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Orthodontics, Maulana Azad Institute of Dental Sciences
New Delhi
DELHI
110002
India |
| Phone |
9810161413 |
| Fax |
|
| Email |
ishaduggal.91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Isha Duggal |
| Designation |
Senior Research Associate |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Orthodontics, Maulana Azad Institute of Dental Sciences
DELHI
110002
India |
| Phone |
9810161413 |
| Fax |
|
| Email |
ishaduggal.91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Human Resource Development Group
CSIR Complex, Library Avenue, Pusa
New Delhi-110012,India |
|
|
Primary Sponsor
|
| Name |
Council of Scientific & Industrial Research (CSIR), India |
| Address |
Human Resource Development Group
CSIR Complex, Library Avenue, Pusa
New Delhi 110 012 India |
| Type of Sponsor |
Government funding agency |
|
|
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 Isha Duggal |
Maulana Azad Institute of Dental Sciences |
Department of Orthodontics,4th floor, Phase 1 building, Maulana Azad Institute of Dental Sciences
New Delhi
DELHI |
9810161413
ishaduggal.91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q899||Congenital malformation, unspecified, (2) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, (3) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Twin Block appliance |
After the complete clinical and radiographic analysis of the patient, the bite registration step will be carried out by instructing the patient to bite on the wax roll in the forward position of the lower jaw. For the purpose of standardization, all appliances will be constructed with the lower jaw brought forward in the Class I molar relationship. The vertical bite registration and interocclusal clearance would all be done by the method recommended by Clark.The working models along with the registered bite will be mounted on an articulator. All the retentive and active wire elements will be fabricated with stainless steel wires and the base plates and occlusal blocks would be made by using the acrylic resin.
The patients and parents will be explained about the instructions regarding how to wear and remove the appliance, duration of wear, eating with the appliance and cleaning of appliance. All the patients will be followed up after 24-48 hours to check for any discomfort or impingement. Subsequently, expansion and trimming steps will be carried out according to Clark’s protocol.
Follow up: The patients will be followed up every month sequentially till the end of treatment (approximately 24 months).
|
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Growing patients diagnosed with skeletal Class II malocclusion due to retrognathic mandible (indicated for TBA)
2. Age group: 9-14 years
3. CVMI stage: 2,3,4
4. Positive visual treatment objective (VTO)
5. Positive informed consent/assent for treatment and use of dental records
|
|
| ExclusionCriteria |
| Details |
1. Patients with signs and symptoms of neuromuscular disorders or temporomandibular disorders
2. Patients with history of previous or current orthodontic treatment
3. Compromised physical or mental health
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)This study will provide insight into the prediction of treatment outcomes with TBA.
2)This study will help in the development of a model which can efficiently and effectively reduce the prolonged hours spent in diagnosis/treatment planning and aid in clinical decision making. Prognostic factors to be considered during the development of treatment plans and clinical protocols for growing Class II patients will largely help in reducing the burden of orthodontic care.
|
1. Pre-treatment (T0)-Before insertion of Twin block appliance
2. Mid-treatment or Post myofunctional therapy (T1)-At the end of 9-12 months of TB therapy (completion of Active phase)
3. Post-treatment (T2)-At the end of treatment period (24 months)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)It will help the clinicians to understand the pitfalls in rendering treatment & achieving patient compliance since discrepancy in the actual results & predicted outcome can be noted.
2)The changes in airway dimensions with TBA may also be predicted. It will have an impact in substantiating the role of functional appliances in treating patients with upper airway disorders. |
1. Pre-treatment (T0)-Before insertion of Twin block appliance
2. Mid-treatment or Post myofunctional therapy (T1)-At the end of 9-12 months of TB therapy (completion of Active phase)
3. Post-treatment (T2)-At the end of treatment period (24 months)
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/08/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The development of a model which can efficiently evaluate the status of treatment, taking multiple associated factors into account, will be time saving and aid in clinical decision making. Any discrepancy between expected outcome obtained from the algorithm and actual result would also assist in evaluating patient compliance. AI would eliminate the inherent subjectivity in planning and possibly obtain more favorable aesthetic and customized outcomes. Using the capabilities and potentials of machine learning and computer vision, data derived precision orthodontic approaches can be facilitated and enhanced. To the best of our knowledge, there is no available AI model in literature that assesses and predicts the outcome of Class II malocclusion correction with TBA. Thus, the purpose of this study is to apply artificial intelligence to build a model that can assess and predict the treatment outcome with Twin Block appliance for correction of Class II malocclusion.
Since the treatment success is highly dependent on the timing of treatment, there is immense potential for the algorithm to be incorporated with the radiographic machine software so that timely referral of the patient can be made by the general dentist/ primary health care centres to the orthodontists/ higher specialized centres. Thus, the developed system may be evaluated on data from multiple centres and finally a software (standalone as well as web-based application) can be developed for wide-spread utility. |