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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  IMPACTED MAXILLARY CANINES 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amit17thjuly@gmail.com].

  6. 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.

  7. 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. 
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