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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  
SELF 
 
Primary Sponsor  
Name  DrMPREVANTH 
Address  NO,2 SCHOOL STREET,POTHERI EAST.603203 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  oral hygiene 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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