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CTRI Number  CTRI/2024/04/064967 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To know the adverse effects of unerupted upper side tooth on the adjacent tooth root using specialised x ray method 
Scientific Title of Study   Evaluation Of the Effects of Location, Angulation, Follicular Status and Proximity of Impacted Maxillary Canines on Root Resorption of Adjacent Teeth Using Cone Beam Computed Tomography – A Cross-Sectional 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  Fahsina Hamza 
Designation  PG student 
Affiliation  MES dental college, Kerala 
Address  MES DENTAL COLLEGE and HOSPITAL,Department Of orthodontics,First Floor,Room No:7,Kolathur (p.o),Perinthalmanna,Malappurum District,Kerala

Malappuram
KERALA
679338
India 
Phone  09745486890  
Fax    
Email  fahsihamza@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.muhamed shaloob 
Designation  Professor  
Affiliation  MES dental college,Kerala 
Address  MES DENTAL COLLEGE and HOSPITAL,Department of Orthodontics,First Floor,Room No:7,Kolathur (p.o),Perinthalmanna ,malappurum District,Kerala

Malappuram
KERALA
679338
India 
Phone  9846353153  
Fax    
Email  shaloobdr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Fahsina Hamza 
Designation  PG student 
Affiliation  MES dental college, Kerala 
Address  MES DENTAL COLLEGE and HOSPITAL,Department Of Orthodontics,First Floor,Room No:7,Kolathur (p.o),Perinthalmanna,Malappurum district,Kerala

Malappuram
KERALA
679338
India 
Phone  09745486890  
Fax    
Email  fahsihamza@gmail.com  
 
Source of Monetary or Material Support  
MES dental college and hospital,Department of orthodontics,1st floor,room no:7,kolathur(p.o),perinthalmanna,Malappurum ,pin:679338 
 
Primary Sponsor  
Name  MES DENTAL COLLEGE 
Address  MES DENTAL COLLEGE,Malaparamba,palachode(p.o),kolathur,perinthalmanna,malappurum(dist),kerala,679338,ph:04933298405 
Type of Sponsor  Private hospital/clinic 
 
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 
DrFahsina Hamza  MES DENTAL COLLEGE,Perinthalmanna  Department of orthodontics,First floor,room No-7,kolathur (p.o),Perinthalmanna,Malappurum,Kerala,
Malappuram
KERALA 
09745486890

fahsihamza@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMITEE MES Dental College  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 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  CBCT of Unilateral or bilateral impacted maxillary canine obtained from patients of
age between 15 – 30 
 
ExclusionCriteria 
Details  1. Congenitally missing central or lateral incisor.
2. Patients with a known orofacial cleft, syndromes.
3. Presence of cysts, other pathologies.
4. Multiple impacted teeth other than canine.
5. Patients with previous history of orthodontic treatment.
6. Pregnant ladies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Root resorption of the adjacent tooth is a consistent feature with impacted maxillary canines.This study is to evaluate the effects of location, angulation, follicular status of impacted maxillary canines and its proximity with adjacent tooth, and to root resorption of adjacent teeth.  T1-Before treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of degree of root resorption of adjacent tooth caused by impacted maxillary canines & to to determine the association between proximity of impacted maxillary canine with adjacent tooth & associated root resorption & to evaluate any association between age of the patient & root resorption of adjacent tooth in patients with impacted maxillary canines.
 
T1 Before treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/04/2024 
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="1"
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 - 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
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 10-10-2024 and end date provided 10-10-2025?
    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   Background

Previous studies in the literature have shown that the impacted maxillary canines may result in several complications like root resorption of adjacent teeth, cystic degeneration, various infections, shortening of dental arch, midline deviation or combination of these factors. This study assesses the effects of location, various angular and linear parameters, follicular width and proximity of impacted maxillary canines with adjacent tooth and associated complications in terms of root resorption of adjacent tooth.

Novelty

Root resorption of the adjacent tooth is a consistent feature with impacted maxillary canines, as noted in previous literature findings. But there are very few studies considering all the available parameters associated with impacted maxillary canine and its significance with respect to root resorption of the adjacent tooth.

PRIMARY OBJECTIVES

1.      To determine association between location, angular and linear parameters and follicular width of impacted maxillary canine and root resorption of adjacent teeth.

Therefore, the purpose of this study is to evaluate location, various angular and linear parameters, follicular status of impacted maxillary canines and its proximity with adjacent tooth, and its correlation to root resorption of adjacent teeth.

SECONDARY OBJECTIVES

1.     To determine the degree of root resorption of adjacent tooth caused by impacted         maxillary canines.

2.     To determine the association between proximity of impacted maxillary canine with adjacent tooth and associated root resorption.

3.     To determine any association between age of the patient and root resorption of adjacent tooth in patients with impacted maxillary canines.

STUDY DESIGN

A cross-sectional study 

STUDY SETTING

Study will be conducted in the Department of Orthodontics and Department of Oral Medicine and Radiology at MES Dental College, Perinthalmanna.

STUDY PERIOD

10th February 2024 to 31st July 2025

STUDY POPULATION

Patients in the age group between 15 to 30 years with unilateral or bilateral maxillary impacted canines reporting for fixed orthodontic treatment to the Department of Orthodontics and Dentofacial Orthopaedics at MES Dental College, Perinthalmanna.

DATA COLLECTION METHODS

The impacted maxillary canines shall be identified by clinical examination and OPG, and supplemented with CBCT.

The patients will be scanned while in standing position using CMOS 9600 3D Face Scan (Carestream Dental). To keep the radiation dose to a minimum, all CBCT images will be taken using a limited dentoalveolar Field Of View (FOV:5*5, 8*8, 8*5). The exposure parameters will be 140KHz, 15mA, and 16 seconds. The CBCT images will be assessed in all 3D (axial, sagittal, coronal) on a flat screen monitor using the CS 3D imaging software (Carestream Dental).

The following analysis and measurements will be performed for every included subject:

Three-dimensional localization of the impacted maxillary canine:

a)     Sagittal: Location of the crown of the impacted maxillary canine in relation to the neighbouring teeth , classified as labial, mid-alveolar, or palatal position, will be assessed using sagittal and/or coronal CBCT scans.

Vertical (h): To measure the height of the impacted canine (h), the vertical distance from the canine cusp tip to the occlusal plane will be measured. The occlusal plane for left and right sides will be determined independently based on a tangent to a)     the incisal edge of the maxillary central incisor and the occlusal surface of the maxillary first permanent molar.

 

Transverse: Measurement of the cusp tip in relation to the midline based on the linear measurement methods will be taken. The maxillary midline is defined from the following reference points depicted on the CBCT: midpalatal suture, anterior nasal spine, and nasal septum. The shortest distance between the tip of the impacted canine and the midline will be measured perpendicularly in mm on respective axial CBCT scans

Mesio distal Position of canine:

The mesio-distal position of the maxillary impacted canine will be determined using modified Sector classification by Lindauer et al

Sector 1

Area distal to line tangent to distal heights of contour of lateral incisor crown and root

Sector 2

Mesial to Sector 1, area from the tangent on the distal surface to a midline bisector of the lateral incisor tooth

Sector 3

Mesial to Sector 2, area from the midline bisector to a tangent to the mesial surface of lateral incisor crown and root.

Sector 4

All areas mesial to Sector 3

Angulation of the canine:(alpha and beta angles):

The angulation of the long axis of impacted maxillary canine with the arch midline (alpha angle) and the angle between the long axis of the impacted canine with the long axis of the adjacent lateral incisor (beta angle) will be analysed using CBCT. (Fig 4) The association between angulation and location of impacted canine measured in CBCT will be compared with the degree of root resorption of adjacent tooth.

Follicular size:

Follicle size measurement at the widest area of the follicle perpendicular to the crown of the impacted canine on coronal and axial CBCT slices will be measured. Distances greater than 3 mm will be considered to be an enlarged follicle.

Proximity with adjacent tooth:

Proximity and/or direct contact of the impacted maxillary canine with incisors or premolars will be determined (yes/no) . Proximity is defined by ≤0.5 mm distance between the two teeth. If yes: then location of the contact in relation to the long axis of the involved tooth is determined and is classified as the cervical, middle, or apical third of the root.

Root resorption of incisors or other teeth (premolars and incisors):

 Location of the root resorption in relation to the long axis of the involved tooth, classified as the cervical, middle, or apical third of the root. Resorption was graded based on the criteria suggested by Ericson and Kurol

Grade 1

No Resorption

Intact root surface, the cementum layer may have been lost

Grade 2

Slight Resorption

Resorption up to half of the dentine thickness

Grade 3

Moderate Resorption

Resorption of the dentine midway to the pulp or more, the pulp lining being unbroken.

Grade 4

Severe Resorption

Resorption reaches the pulp




EXPECTED OUTCOME

Primary outcome will be the association between location, angular, linear parameters and follicular width of impacted maxillary canine and root resorption of adjacent teeth. The secondary outcome will be the association between proximity of impacted maxillary canine with adjacent tooth and associated root resorption as well as the degree of root resorption of adjacent tooth caused by impacted maxillary canines.

BENEFITS FROM OUTCOME

As canine impaction is a routinely encountered problem, outcome can be utilised in reducing the rapid progression of root resorption.  

 
 
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