| CTRI Number |
CTRI/2021/04/032575 [Registered on: 06/04/2021] Trial Registered Prospectively |
| Last Modified On: |
02/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of excessive mobile usage and its impact on hand grip and mouth |
|
Scientific Title of Study
|
Association between mobile smartphone addiction on hand grip strength and its impact on oral hygiene- a cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMPRevanth |
| Designation |
Post Graduate student |
| Affiliation |
Ragas dental college and hospital |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY,RAGAS DENTAL COLLEGE AND HOSPITAL,2/102,EAST COAST ROAD,UTHANDI,CHENNAI. DEPARTMENT OF PUBLIC HEALTH DENTISTRY,RAGAS DENTAL COLLEGE AND HOSPITAL,2/102,EAST COAST ROAD,UTHANDI,CHENNAI. Chennai TAMIL NADU 600119 India |
| Phone |
09940268423 |
| Fax |
|
| Email |
revanthmpbds95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrSAPARNA |
| Designation |
READER |
| Affiliation |
Ragas dental college and hospital |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY,RAGAS DENTAL COLLEGE AND HOSPITAL,2/102,EAST COAST ROAD,UTHANDI,CHENNAI. DEPARTMENT OF PUBLIC HEALTH DENTISTRY,RAGAS DENTAL COLLEGE AND HOSPITAL,2/102,EAST COAST ROAD,UTHANDI,CHENNAI. Chennai TAMIL NADU 600119 India |
| Phone |
09940268423 |
| Fax |
|
| Email |
abi_aparna1986@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
DrMPRevanth |
| Designation |
Post Graduate student |
| Affiliation |
Ragas dental college and hospital |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY,RAGAS DENTAL COLLEGE AND HOSPITAL,2/102,EAST COAST ROAD,UTHANDI,CHENNAI. DEPARTMENT OF PUBLIC HEALTH DENTISTRY,RAGAS DENTAL COLLEGE AND HOSPITAL,2/102,EAST COAST ROAD,UTHANDI,CHENNAI. Chennai TAMIL NADU 600119 India |
| Phone |
09940268423 |
| Fax |
|
| Email |
revanthmpbds95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrMPREVANTH |
| Address |
NO,2 SCHOOL STREET,POTHERI EAST.603203 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| KURINJISELVAN |
NATIONAL INSTITUTE FOR EMPOWERMENT OF PERSONS WITH MULTIPLE DISABILITIES |
DEPARTMENT OF OCCUPATIONAL THERAPY,MUTTUKADU,KOVALAM.603112. Kancheepuram TAMIL NADU |
7356857817
kurinji85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAGAS DENTAL COLLEGE and HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
oral hygiene |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
33.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects owning mobile smartphones for more than 5 years.
2.Subjects who give consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with neuropathy and tendon lesions.
2.Presence of a full hand or wrist bandage.
3.Presence of hand paralysis.
4.Presence of hand or finger casting.
5.Subject with history of trauma, systemic disease, and pathological conditions related to oral cavity.
6.Subjects with deleterious habits (smoking, alcohol).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ORAL HYGIENE |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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)
|
13/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In the past decade there has been a
rapid increase in the use of mobile devices, particularly smartphones, for
communication and internet browsing. A recent study shows that 79% of the
population between the age 18-44 years have their cell phones with them almost
all the time, with only 2 hours of their walking day spend without their cell
in hand. Extensive use of smartphones can be associated with physical
health–related problems, such as pain in the wrists and neck, and it also
exposes hands to intense stresses that may lead to pain and musculoskeletal
disorders of the hand and thumb. Single-hand-held smartphone use compels
individuals to engage in repetitive flexion/extension of the wrist and thumb.
Continuous repetitive movements with the thumb have been identified as risk
factors which may lead to disorders of its musculature causing musculoskeletal
disorders (MSD) like tendinosis of the extensor pollicis longus (EPL) and
flexor pollicis longus tendon (FPL) and the joints of the thumb. To date,
little is known about the possible adverse effects of mobile phone overuse on
the hand and thumbs. Case reports suggest a link between high keystroke counts
and hand disorders, such as first carpometacarpal osteoarthritis and De Quervain
tenosynovitis. Severity of this condition in the hands is correlated with
impaired functional ability. Hence, many people with MSD in their hands are
unable to maintain proper oral hygiene, resulting in accumulation of plaque and
calculus, which increases the likelihood of dental caries and periodontal
disease. Few studies have been reported about this substantial increase in the
number of smartphone users and its association with musculoskeletal discomfort
but not on its impact on oral cavity or oral hygiene maintenance. Hence, the
aim of this present study is to assess the level of smart phone addiction and
its association with hand grip strength and its impact on oral hygiene. |