| CTRI Number |
CTRI/2024/03/063768 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of occlusal forces in normal subjects versus subjects with wearing off of teeth |
|
Scientific Title of Study
|
Comparative evaluation of magnitude of occlusal forces among completely dentate subjects having discrepancy in vertical dimension of occlusion (VDO) and subjects having unaltered vertical dimension of occlusion(VDO) by using 2D/3D analogue( Occlusense by Bausch )-an invivo 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 |
Metorilang Sohlang |
| Designation |
Junior resident |
| Affiliation |
Faculty of Dental Sciences,IMS,BHU |
| Address |
Unit of Prosthodontics,Crown and Bridge and Oral Implantology,2nd Floor, Faculty of Dental Sciences,BHU,Trauma Centre,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8837247031 |
| Fax |
|
| Email |
metorilang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Kumar Dubey |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Dental Sciences,IMS,BHU |
| Address |
Unit of Prosthodontics,Crown and Bridge and Oral Implantology,2nd Floor, Faculty of Dental Sciences,BHU,Trauma Centre,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drpavan26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Metorilang Sohlang |
| Designation |
Junior resident |
| Affiliation |
Faculty of Dental Sciences,IMS,BHU |
| Address |
Unit of Prosthodontics,Crown and Bridge and Oral Implantology,2nd Floor, Faculty of Dental Sciences,BHU,Trauma Centre,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8837247031 |
| Fax |
|
| Email |
metorilang@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences,Institute of Medical Sciences,BHU,Varanasi |
|
|
Primary Sponsor
|
| Name |
Metorilang Sohlang |
| Address |
Unit of Prosthodontics,Crown and Bridge and Oral Implantology,2nd floor,Faculty of Dental Sciences,BHU,Trauma Centre,Varanasi |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Metorilang Sohlang |
Faculty of Dental Sciences,IMS,BHU |
Room no.4,2nd Floor ,Unit of Prosthodontics,Crown and Bridge and Oral Implantology
Varanasi
UTTAR PRADESH |
8837247031
metorilang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,IMS,BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
loss in vertical dimension of occlusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with chief complain of inability to chew
2.Patients with discrepancy in vertical dimension of occlusion
3.No acute infection present
4.Patient’s cooperation, motivation and good oral hygiene
5.Signed inform consent.
|
|
| ExclusionCriteria |
| Details |
1.Presence of acute or chronic infections
2. Patients with history of extractions or missing teeth
3. Patients with crowns and bridges
4.Patient with periodontal problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Magnitude of occlusal forces |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vertical dimension of occlusion |
Baseline |
|
|
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)
|
01/04/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
A sample of 75 subjects will be selected from the OPD of
Unit of Prosthodontic ,Faculty of Dental Sciences, IMS,BHU according to
inclusion and exclusion criterion. The subjects will be further divided into 3
groups-25 subjects in Group 1 (normal fully dentate subjects) acting as Control
group,50 subjects in the Study Group i.e.,25 in Group 2 (subjects having
attrition with altered vertical dimension of occlusion) and 25 in Group 3
(subjects having attrition with unaltered vertical dimension of
occlusion).After taking proper case history. Patients will be evaluated
clinically and radiographically .The patients will be explained and informed
regarding the nature of the study and their participation will be included
after they have signed the informed consent.
The vertical dimension of occlusion of each subjects will be
assessed. Each subject will be categorized according to the Turner and
Missirlian classification 1984.Occlusal biting force of each subjects will be
assessed by using the 2D/3D device (Occlusense by Bausch) in static occlusion
corresponding to the maximum intercuspation (MIP) in clinical condition .Forces
will be recorded for all 4 quadrants . A comparison will be made among the
Control Group and the two Study Groups.A final conclusion if whether the
magnitude of occlusal forces in the 2 Study Groups is close to that of the
Control group will be established towards the end of the study. |