| CTRI Number |
CTRI/2025/07/091699 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observation of different bony and tooth related measurements in non-erupted canine cases: A CBCT study |
|
Scientific Title of Study
|
Analysis of various bony and dental measurements in impacted canine cases: 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 Prof Ajay Gupta |
| Designation |
Professor, Department of orthodontics and dentofacial orthopedics |
| Affiliation |
UTTARANCHAL DENTAL AND MEDICAL RESEARCH INSTITUTE |
| Address |
Room No. 6, Department of Orthodontics and dentofacial Orthopedics, UDMRI, Mazri Grant, Dehradun.
Dehradun UTTARANCHAL 248140 India |
| Phone |
9818758144 |
| Fax |
|
| Email |
drajaygupta04@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Amit Silori |
| Designation |
MDS Student |
| Affiliation |
UTTARANCHAL DENTAL AND MEDICAL RESEARCH INSTITUTE |
| Address |
Gayatri puram Miyanwala Post Harrawala, Dehradun. Mazri Grant near Doiwala, Haridwar road, Dehradun Dehradun UTTARANCHAL 248001 India |
| Phone |
9897835844 |
| Fax |
|
| Email |
amit17thjuly@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Amit Silori |
| Designation |
MDS Student |
| Affiliation |
UTTARANCHAL DENTAL AND MEDICAL RESEARCH INSTITUTE |
| Address |
Gayatri puram Miyanwala Post Harrawala, Dehradun.
Dehradun UTTARANCHAL 248001 India |
| Phone |
9897835844 |
| Fax |
|
| Email |
amit17thjuly@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthodontics and dentofacial orthopedics UDMRI Dehradun |
|
|
Primary Sponsor
|
| Name |
Uttaranchal Dental and medical research institute |
| Address |
Mazri grant, Haridwar road, Dehradun. Uttarakhand 240140 |
| Type of Sponsor |
Other [Private dental college] |
|
|
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 |
| AMIT SILORI |
UTTARANCHAL DENTAL AND MEDICAL RESEARCH INSTITUTE |
Mazri Grant Near Doiwala,
Haridwar Road, Dehradun Dehradun UTTARANCHAL |
09897835844
amit17thjuly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttaranchal Dental and medical research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
IMPACTED MAXILLARY CANINES |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Impaction of permanent maxillary canines
CBCT images with good image quality
|
|
| ExclusionCriteria |
| Details |
No systemic disease, Without syndrome or cleft palate, Without orthodontic treatment, No contributing history of trauma and Presence of cysts or other pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the different skeletal and dental parameters in impacted canine using CBCT study |
To investigate the different skeletal and dental parameters in impacted canine using CBCT study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| inter canine distance, root resorption of adjacent teeth, inter premolar distance, canine root length, canine angulation, distance from midline, crown length, root length shape and size of adjacent teeth. |
ONE TIME AFTER THE CBCT SCAN |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
08/08/2025 |
| 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="0" Months="6" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amit17thjuly@gmail.com].
- For how long will this data be available start date provided 04-12-2026 and end date provided 04-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The unilateral maxillary canine impaction is more commonly seen in females than in males, with a prevalence of 1% to 9.7%. The maxillary canines have a long tortuous path of eruption around 22 millimeters below the orbital floor. The maxillary canine is positioned high along the distal side of the apical third of the maxillary lateral incisor root which serves as a guide along which the canine erupts. Interestingly, the development of the lateral incisor plays a big role in guiding the upper canine into its position. Disturbance with the shape, size, and number of these teeth can contribute to the impaction of the upper canine, especially towards the palatal side. There are various factors that can lead to impaction of the maxillary canine which include local and systemic factors such as anomalies in tooth size and shape, early loss of deciduous teeth, or cysts, endocrine deficiencies or genetic factors. Researchers have proposed several theories to explain the palatal impaction of canine. Becker et al suggested that canine follow the path guided by neighboring lateral incisor root. Another theory by Peck et al accounts for the genetic factors and other dental anomalies for maxillary canine impaction. The orthodontic treatment of impacted maxillary canine is complicated, which aims to move teeth in three-dimensional spaces. This can be intricate due to nearby important structures like nerves and sinuses, particularly the large air-filled space in the upper jaw known as the maxillary sinus. Complications of impacted canines can include root resorption of neighboring teeth. There’s also a link between canine impaction and deviation of the nasal septum, the cartilage and bone that separates the nostrils. According to Ellaithy MM et al Nasal septum deviation was significantly greater in the impaction groups compared with the control group (no impaction). Cone beam computed tomography (CBCT) provides detailed three-dimensional images which is used in the accurate and precise diagnosis and treatment planning of the impacted canine. Overall, dealing with impacted canines involves understanding about the anatomy of the jaw and sinuses, how teeth develop and how these factors interact. With careful diagnosis and treatment planning, orthodontists can help patients overcome these challenges and achieve a healthy smile. Hence, this study aims at to investigate and analyze the various bony and dental parameters in maxillary impacted canine cases. |