| CTRI Number |
CTRI/2025/03/083059 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To check proximity between incisive canal and upper front teeth after moving them backwards using CBCT |
|
Scientific Title of Study
|
Evaluation of Proximity Between Incisive Canal and Maxillary Central Incisor After Anterior Retraction: A CBCT 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 AJAY K |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SURENDRA DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Surendra dental college ,His highness garden,sadhulshahar road,sriganganagar
Ganganagar RAJASTHAN 335001 India |
| Phone |
9526504158 |
| Fax |
|
| Email |
ajaykuttu45@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr EENAL BHAMBRI |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
SURENDRA DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Surendra dental college ,His highness garden,sadhulshahar road,sriganganagar
Ganganagar RAJASTHAN 335001 India |
| Phone |
8769829700 |
| Fax |
|
| Email |
dreenal700@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr EENAL BHAMBRI |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
SURENDRA DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Surendra dental college ,His highness garden,sadhulshahar road,sriganganagar
Ganganagar RAJASTHAN 335001 India |
| Phone |
8769829700 |
| Fax |
|
| Email |
dreenal700@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopaedics, Room No. 3, A Block, Surendera Dental College and Research Institute, Sri Ganganagar, Rajasthan, 335001 |
|
|
Primary Sponsor
|
| Name |
Dr Ajay K |
| Address |
Surendera dental college and research institute,his higness garden,powerhouse road,sriganganagar,Rajasthan,335001 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Ajay K |
Surendera dental college and research institute |
Department of Orthodontics and Dentofacial Orthopaedics, Room No. 3, A Block, Surendera Dental College and Research Institute, Sri Ganganagar, Rajasthan, 335001 Ganganagar RAJASTHAN |
9526504158
ajaykuttu45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SDCRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Angles class II div I malocclusion |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with bimaxillary dentoalveolar protrusion or Angle’s class II division 1 malocclusion requiring extraction of 1st premolar.
2.Moderate to maximum anchorage cases will be considered.
3.The removal of bilateral maxillary first premolars during the orthodontic treatment followed by en masse retraction.
4.No history of trauma to the maxillary and mandibular anterior teeth |
|
| ExclusionCriteria |
| Details |
1.Root length (the distance from the cementoenamel junction to apex) of maxillary incisors was less than 9 mm in T0 CBCT
2.Low CBCT image quality the cortical bone and root could not be defined accurately. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess if lowerly positioned incisive canal will contact upper incisor roots after retraction |
data will be collected at baseline and after 10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate whether contact between the upper incisor root & the incisive canal can result in root resorption. |
data will be collected at baseline & after 10 months |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
25/06/2025 |
| 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="2" Months="1" Days="2" |
|
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
|
AIM:To analyze the effect of upper anterior teeth retraction on the root proximity to the incisive canal (IC). OBJECTIVES:.1.To evaluate the effects of retraction on the proximity of incisive canal and roots of anterior teeth using CBCT 2.To assess the changes in the incisive canal (IC) and its relationship with the upper first incisor (U1) by measuring IC height, IC width, and U1-IC distances at multiple levels. 3.To explore the risk factors for contact between the incisive canal (IC) and upper central incisors (U1) and to evaluate the relationship between contact and root resorption. 4.To ensure consistency and accuracy in measurements by using a standardized method of evaluating CBCT data, with pre-retraction and post-retraction data compared for each patient, accounting for factors such as head position and anatomical landmarks (e.g., ANS, PNS). Methodology CBCT scan will be obtained for maxillary anteriors including canine at 8x8 cm field of view, 90 KV, 8 MVA, 11.4 second scan time and 200 micron voxel size Veraview X 800 model machine. They will be taken at two time periods a) before treatment b) after retraction Further which will be analyzed using i- Dixel software, ensuring the standardization of head position.Axial and sagittal sections are collected from each sample. Axial sections will be aligned parallel to the Frankfort plane, while sagittal sections will be made vertical to the axial plane and parallel to the connection between the anterior nasal spine (ANS) and posterior nasal spine (PNS). Coronal sections will then be made perpendicular to both the axial and sagittal sections Several measurements will be conducted using the 3D measurement function of i-Dixel software: Incisive Canal (IC) Height: Will be defined as the vertical distance between the incisive foramen plane and the cemento-enamel junction (CEJ). The incisive foramen plane will be the horizontal plane passing through the lowest point of the buccal wall of the IC IC Width: Will be defined as the transverse distance parallel to coronal sections between the most distal points of the IC. IC width will be measured at three horizontal levels in the sagittal view, ensuring consistency by recording the vertical distance between each level and the horizontal line passing through the ANS in pre-retraction images and transferring these levels to post-retraction images. The average of these three levels will be calculated for each patient. U1-IC Distances: These will be measured at the same three horizontal levels and will be defined as the anteroposterior distance from the most mesial point of the upper first incisor (U1) to the cortical plate of the IC. Measurements will be recorded separately for the left and right sides. U1-IC Decrease: Will be defined as the difference between the pre-treatment and post-treatment U1-IC distances. If the root comes into contact with or invades the IC, the distance will be recorded as 0 mm. Root Length Measurement: The root length of both left and right U1 before and after retraction will be measured in the sagittal view. Inclination change: Measurements of the inclination of U1 before and after retraction will bemeasured in the sagittal view.inclination will be measured between tooth axis and H line Horizontal retraction distance: horizontal retraction distance (HRD) of U1 , the perpendicular distance between the maxillary incisor edge and V-line Vertical dental position:vertical position of tooth is the perpendicular distance between the maxillary incisor edgeand the H-line |