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CTRI Number  CTRI/2024/11/077334 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Association of unerupted canine with the other features in the upper jaw 
Scientific Title of Study   Association of canine impaction with morphological features of maxillary structures- a retrospective cross sectional observational study using CBCT. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1315-7727  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mridul Khanduri 
Designation  Professor and Head Department of Orthodontics and Dentofacial Orthopedics 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room No. 6, Dept of Orthodontics and Dentofacial Orthopedics, Uttaranchal Dental and Medical Research Institute, Majri Grant, Haridwar road

Dehradun
UTTARANCHAL
248140
India 
Phone  9897331843  
Fax    
Email  mridulkhanduri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Meru S 
Designation  Professor and Head, Dept of Oral Medicine and Radiology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room No 1, Dept of Oral Medicine and Radiology, Uttaranchal Dental and Medical Research Institute, Majri grant, Haridwar road,

Dehradun
UTTARANCHAL
248140
India 
Phone  8126192404  
Fax    
Email  drmeru@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Meru S 
Designation  Professor and Head, Dept of Oral Medicine and Radiology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room No 1, Dept of Oral Medicine and Radiology, Uttaranchal Dental and Medical Research Institute, Majri grant, Haridwar road,


UTTARANCHAL
248140
India 
Phone  8126192404  
Fax    
Email  drmeru@gmail.com  
 
Source of Monetary or Material Support  
CBCT Reporting center, Uttaranchal Dental and Medical Research Institute, Majri Grant, Haridwar road, Dehradun, Uttarakhand India, 248140 
 
Primary Sponsor  
Name  Uttarancahl Dental and Medical Research Institute 
Address  Majri Grant, Haridwar road, DEhradun, Uttarakhand, 240140 
Type of Sponsor  Other [Private Dental college] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mridul Khanduri  Uttaranchal Dental and Medical Research Institute  Room No 6, Depart ment of Orthodontics, Majri Grant, Haridwar road
Dehradun
UTTARANCHAL 
9897331843

mridulkhanduri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Uttarancal Dental and Medical Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil  
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Unilateral maxillary canine impaction.
CBCT images if good quality.
CBCT images with FOV of maxilla. 
 
ExclusionCriteria 
Details  Bilateral maxillary canine impaction.
Patients cleft palate.
patients who have developed dentigerous cyst involving impacted canine. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Distance of canine to midline
Inter canine distance
Inter premolar distance
Inter molar distance
ANgulation of canine, Lateral Incisor and Premolar
Distance of canine from first and second premolar

 
One time after the scan has been selected for inclusion in the study. Recording of observations will take 30 minutes per scan  
 
Secondary Outcome  
Outcome  TimePoints 
Distance of canine to midline
Inter canine distance
Inter premolar distance
Width of the nasal cavity
Canine dimensions.
Thickness of buccal and palatal cortex
Alveolar height
Inter molar distance
Angulation of canine, Lateral Incisor and Premolar
Distance of canine from first and second premolar

 
One time after the scan has been selected for inclusion in the study. Recording of observations will take 30 minutes per scan  
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   09/12/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 30-06-2030?
    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 prevalence of canine impaction has been reported to be 1%-4% in different geographic and ethnic populations, this being  higher in patients reporting for orthodontic treatment than estimated for general public, thus validating its influence on malocclusion, esthetics and function. The importance of canine in smile anatomy and physiology is ever established, not only due to the insertion of zygomaticus major, which is one of the important muscles during smiling and also its position at the corner while smiling.  The canine to canine width not only holds the symmetrical smile line but also determines the smile arch.  To a beholder the canines are as important in smile as lateral incisor and central incisor. Thus absence of the canine, which could be due to agenesis ,extraction or impaction, leads to a disharmony not only in smile esthetics but also in masticatory function and may also lead to TMJ dysfunction due to loss of canine protected occlusion.

Thus diagnosing and treating an impacted canine has always been an enigma to the Radiologist as well as an Orthodontist, which needs an interdisciplinary approach to effecting a near perfect or ideal treatment.  The team may consist of orthodontist, radiologist, oral surgeon, pedodontist, periodontist and even endodontist and prosthodontist depending on the severity and complications of the case involved, the obsession with canine and its management for orthodontist is engrained so as to never lose an impacted canine. Multiple methods have been used for diagnosing an impacted maxillary canine such as inspection, palpation and radiographs.  Radiography has time and again been used with intra oral and extra oral techniques to locate the impacted canine in maxilla.  periapical and occlusal films (intraoral) and lateral and frontal cephalograms, OPG, and CT images(extra oral techniques)have also been used. Timely prediction and intervention of canine impaction has a probability of better prognosis

Though OPG (panoramic view) has been an invaluable tool to determine the position of impacted tooth in the jaw bones but as it has its limitations in determining the buccal and palatal position of the offending tooth as well as the related root resorption of the adjacent tooth which, is difficult to identify. CBCT imaging while on the other hand has the advantage of being more accurate, reliable and of high resolution.  Thus in the present study it was attempted through any associated anatomical and morphological differences, when studied in cases of unilateral maxillary canine impaction, to predict their association with the  said anomaly using CBCT imaging.

Materials and methods: CBCT images of patients with unilateral maxillary canine impactions will be selected retrospectively from the collection of radiographic images of patients treated at the study site.

Each of the scans meeting the inclusion criteria will be studied and observations will be recorded by an experienced Oral radiologist. 


Statistics: the data obtained will be analyzed with statistical tests.

 
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