| 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
|
|
|
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
|
|
|
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
- 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).
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmeru@gmail.com].
- 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.
- 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. |