| CTRI Number |
CTRI/2021/05/033887 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
28/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To determine accurately the part of tragus to be used to form the ala-tragus line or camper’s line while establishing the occlusal plane in edentulous patients using photographic and cephalometric methods. |
|
Scientific Title of Study
|
“Comparative evaluation of occlusal plane parallelism at different levels of ala tragus lines in dentulous patients-An in vivo study.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jay Dineshbhai Patel |
| Designation |
PG Student |
| Affiliation |
Manubhai Patel Dental College Hospital and ORI Munjmahuda Vadodara |
| Address |
Department of Prosthodontics Crown And Bridge
PG division
Vishwajyoti Ashram Near Vidyakunj School Muj Mahuda Vadodara Gujarat 390011
Department of Prosthodontics Crown And Bridge
PG division
Vishwajyoti Ashram Near Vidyakunj School Muj Mahuda Vadodara Gujarat 390011
Vadodara
GUJARAT
390011
India |
| Phone |
9979582083 |
| Fax |
|
| Email |
jaypatel4360@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Gaurang Mehta |
| Designation |
PG Guide |
| Affiliation |
Manubhai Patel Dental College Hospital and ORI Munjmahuda Vadodara |
| Address |
23 Sujata society Near Harinagar Gotri Road Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
|
| Fax |
|
| Email |
docsonalmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jay Dineshbhai Patel |
| Designation |
PG Student |
| Affiliation |
Manubhai Patel Dental College Hospital and ORI Munjmahuda Vadodara |
| Address |
Department of Prosthodontics Crown And Bridge
PG division
Vishwajyoti Ashram Near Vidyakunj School Muj Mahuda Vadodara Gujarat 390011
Department of Prosthodontics Crown And Bridge
PG division
Vishwajyoti Ashram Near Vidyakunj School Muj Mahuda Vadodara Gujarat 390011
Vadodara
GUJARAT
390011
India |
| Phone |
9979582083 |
| Fax |
|
| Email |
jaypatel4360@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manubhai Patel Dental College
Hospital and ORI
Munjmahuda Vadodara
|
|
|
Primary Sponsor
|
| Name |
Dr Jay Dineshbhai Patel |
| Address |
D7 Indralok bunglows Near Niti nagar society Near Breadliner circle U M Road Canal road Surat |
| Type of Sponsor |
Other [Myself] |
|
|
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 Jay Dineshbhai Patel |
Manubhai Patel Dental College Hospital and ORI Munjmahuda Vadodara |
Department of Prosthodontics Crown and bridge
PG Division
Vishwajyoti Ashram Near Vidyakunj School Muj Mahuda Vadodara Gujarat 390011
Vadodara
GUJARAT |
9979582083
jaypatel4360@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHARAJA KRISHNAKUMARSINHJI BHAVNAGAR UNIVERSITY ETHICS COMMITTEE FOR MDS COURSE AND DENTAL RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers age between 18 to 40 yeras with straight orthognathic profile |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 18 40 years By 18 years growth of the face ceases and there is no change in the relationship of campers plane to the occlusal plane The upper age limit was restricted to 40 years as at this age a dentition can be expected to remain normal without tooth loss and excessive attrition
Straight or orthognathic profile For the ease of the comparison of the angulations
Subjects should have regular alignment of teeth without any supra eruption or drifting ie well formed occlusion
Subjects should have complete dentition of 24 teeth occlusal plane will be considered from the incisal edges of the upper central incisor to cusps of first molar
A minimum of conservative treatment and that must not affect the occlusion plan
|
|
| ExclusionCriteria |
| Details |
Previous history of orthodontic treatment
Congenitally missing or extracted teeth
Subjects should not have crowns fixed or removable partial dentures or supernumerary teeth or retained teeth
Subjects with deciduous teeth
Congenital or acquired defects in the head region
Advanced periodontal diseases and associated tooth mobility
TMJ disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The expected outcome for the present study would be in dentulous subjects the line drawn from the ala of the nose to the inferior part of the tragus will be relatively parallel to occlusal plane both in lateral cephalogram and lateral profile photograph. |
Baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be no significant difference found between angle measured on lateral cephalogram and profile photograph as well as no influence of gender on the selection of part of tragus for ala-tragus line. |
Baseline. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/06/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Precise orientation of the occlusal plane plays a vital role in
providing optimal aesthetic, phonetics and mastication. It has been a great deal of
controversy regarding the anatomic reference point taken in identifying ala-tragus line
to which the occlusal plane is oriented parallel while making complete denture.Thus,The Purpose of the study is to determine accurately the part of tragus to be used to form the ala-tragus
line or camper’s line while establishing the occlusal plane in edentulous patients using
photographic and cephalometric methods.A total of 100 subjects will be selected for the study. In first
stage, for photographic analysis Photographs will be taken with the subject standing in
their natural head position. Then, fox bite plane will be placed in the mouth in such a
position that it touched the incisal edges of the maxillary incisors and the cusps of the
left and right maxillary first molar. The plane will be held in the position by pressure
from the opposing teeth. The outer wing of the plane indicates the position of the
occlusal plane and these are readily seen in the photographs. The dots on superior
(T1), middle (T2) and inferior (T3) margins of the right tragus, lower point of ala of
nose (A) and Orbital point (O) will be directly placed on the photo in computer. In
second stage, for cephalometric analysis- Three points will be identified on tragus of ear
as superior (T1), middle (T2) and inferior (T3). The stainless-steel balls (3 mm in
diameter) will be fixed at these selected points and also both at the lowest point of the
ala of the nose(A) and the lowest point on the inferior border of bony orbit (Or) with
fine quality double sided adhesive tape to ensure perfect placement to capture the
recording on cephalographs. Statistical Analysis: The statistical analysis will be carried
out using Descriptive analysis (mean, standard deviation, CI), independent T test and
paired T-test. Total 100 (50 male and 50 female) participants for the present study
will be selected to estimate mean difference in angles by 1.65 degree with standard
deviation of 3.2 at 95% confidence and 80% power.
|