| CTRI Number |
CTRI/2023/10/058568 [Registered on: 12/10/2023] Trial Registered Prospectively |
| Last Modified On: |
11/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Assessing tiredness and hand grip strength following different work postures during treatment among dental students |
|
Scientific Title of Study
|
Evaluation of students discomfort, fatigue and hand grip strength following dental procedures under conventional and proprioceptive derivation methods. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keerthipati Bhavitha |
| Designation |
Under Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Vishnu Dental College,Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7075291723 |
| Fax |
|
| Email |
keerthipati.bhavitha@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Kumar Pasupuleti |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Periodontics, Vishnu Dental College,Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
|
| Email |
mosups@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Kumar Pasupuleti |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Periodontics, Vishnu Dental College,Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
|
| Email |
mosups@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Bhimavaram |
|
|
Primary Sponsor
|
| Name |
Vishnu Dental College |
| Address |
Vishnu Dental College,Vishnupur,Bhimavaram, Andhra Pradesh, India, pin code-534202 |
| 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 Mohan Kumar P |
Vishnu Dental College |
UG Clinic -3 , Department of Public health dentistry ,Block -3
West Godavari
ANDHRA PRADESH |
7799411140
mosups@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,VishnuDentalCollege |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Students who are musculoskeletally healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional method |
Fatigue, discomfort and hand grip strength are evaluated before and after the oral prohylaxis, dental restorations and extraction treatment procedures using Fatigue Assessment Scale, Verbal rating scale and Digital grip analyzer respectively.
|
| Intervention |
Proprioceptive derivation method |
Fatigue, discomfort and hand grip strength are evaluated before and after the oral prohylaxis, dental restorations and extraction treatment procedures using Fatigue Assessment Scale, Verbal rating scale and Digital grip analyzer respectively.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Month(s) |
| Age To |
25.00 Month(s) |
| Gender |
Both |
| Details |
1. Volunteers trained in performing dental treatment procedures. |
|
| ExclusionCriteria |
| Details |
1. Volunteers with neuromuscular problems
2. Volunteers with musculoskeletal problems |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand grip strength |
Baseline and post operatively 0-5min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Fatigue
2. Discomfort |
1. Fatigue - Fatigue assessment scale post operatively 0-5min
2. Discomfort - Verbal rating scale post operatively 0-5min |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
21/10/2023 |
| 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="2"
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 - NO
|
|
Brief Summary
|
150 participants will be recruited and divided into 2 groups. Hand grip strength, fatigue and discomfort will be evaluated and compared before and after the routine dental treatment procedures in both conventional method and proprioceptive derivation method to assess the effectiveness of work postures in both the methods. |