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CTRI Number  CTRI/2017/04/008411 [Registered on: 25/04/2017] Trial Registered Prospectively
Last Modified On: 24/04/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of exercises on facial muscle in complete denture patients  
Scientific Title of Study   Comparative evaluation of the effect of muscle conditioning and retraining exercises on EMG activity and Bite force in complete denture patients- Randomized control 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 Neerja Mahajan 
Designation  Professor 
Affiliation  Sumandeep Vidyapeeth 
Address  The Department of Prosthodontics, K M Shah Dental College and Hospital, Pipariya, Vadodara
The Department of Prosthodontics, K M Shah Dental College and Hospital, Pipariya, Vadodara-391760
Vadodara
GUJARAT
391760
India 
Phone  9898036619  
Fax    
Email  drneerjamahajan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neerja Mahajan 
Designation  Professor 
Affiliation  Sumandeep Vidyapeeth  
Address  The Department of Prosthodontics, K M Shah Dental College and Hospital, Pipariya, Vadodara.
The Department of Prosthodontics, K M Shah Dental College and Hospital, Pipariya, Vadodara-391760
Vadodara
GUJARAT
391760
India 
Phone  9898036619  
Fax    
Email  drneerjamahajan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neerja Mahajan 
Designation  Professor 
Affiliation  Sumandeep Vidyapeeth  
Address  The Department of Prosthodontics, K M Shah Dental College and Hospital, Pipariya, Vadodara.
The Department of Prosthodontics, K M Shah Dental College and Hospital, Pipariya, Vadodara-391760
Vadodara
GUJARAT
391760
India 
Phone  9898036619  
Fax    
Email  drneerjamahajan@gmail.com  
 
Source of Monetary or Material Support  
Sumandeep Vidyapeeth,At&Po.-Pipariya,Ta-Waghodia,Dist-Vadodara -391760 
 
Primary Sponsor  
Name  Sumandeep Vidyapeeth 
Address  At.& Po.Pipariya, Ta.Waghodia,Dist.Vadodara-391760 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Neerja Mahajan  K M Shah Dental college and Hospital,SBKS Medical college and Research center, Dhiraj Hospital  The Department of Prosthodontics, The Department of Neurology
Vadodara
GUJARAT 		 9898036619

drneerjamahajan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE (SVIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Edentulous patients between 60-75 years requiring complete dentures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  • Facial conditioning exercises.(RALPH H. BOOS et al in 1958) • Muscle retraining exercises as suggested by (Raina D’souza et al IN 2014)   Participants will be instructed to perform facial muscle conditioning 4 times in a day for 2 to 3 minutes for total 30-days period . Participants will also perform muscle retraining exercises like face lifting and lip exercises for 10 seconds per exercise in a day and strengthening the mandibular shape for minimum 5 second per exercises in a day for 30 days  
Intervention  cases  in edentulous patients with muscle conditioning and retraining excercises 
Comparator Agent  control   in edentulous patients without muscle conditioning and retraining excercises 
Comparator Agent  No Facial conditioning and Muscle retraining exercises   Participants will not perform Facial conditioning and Muscle retraining exercises for 30 days 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Completely edentulous patients reporting to Dept. of Prosthodontics, crown & bridge, KMSDCH with complete denture treatment needs.
2. Patients above 60 years of age (male & female) up to 75 years will be included in the study.
3. Patients with no history of previous denture.
4. Patients having minimum period of 2 months after full extractions.
5. Patients will be screened for tonicity problems according to Netters test
 
 
ExclusionCriteria 
Details  1. All patients with recent extractions.
2. Patients who refuse to participate in the study
3. Patients with single complete denture
4. Patients having any kind of uncontrolled systemic problem
5. Patients having prognathic and retrognathic jaw relations
6. Patients with known psychological conditions or problems.
7. Acute / chronic symptoms of temporomandibular disorder.
8. Pendulous residual ridge.
9. Smokers and tobacco user
10. Intra Oral defects.
11. Submucous fibrosis.
12. Any intraoral lesions.
13. Patients with neuromascular disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of muscle conditioning and retraining excercises on EMG activity of masseter, buccinators, orbicularis oris and temporalis muscles.   At baseline, 1 month and 2 months of time intervals in the complete denture patients  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of muscle conditioning and retraining excercises on bite force in complete denture patients  At baseline, 1 month and 2 months of time intervals in the complete denture patients  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/05/2017 
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="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)?  

Brief Summary  

Many studies till date had been conducted which analyzed the EMG and Bite force analysis in the elderly denture wearing patients. The research till date has mainly concentrated on the therapeutic aspects only, in which  patients  with  history of Temporomandibular disorder, trauma and existing oral defects were confirmed by EMG analysis and  then exercises were used as one of the therapeutic approaches or as adjunct therapies  with encouraging results.

After doing the literature search in EBSCO, PUBMED and MEDLINE data bases no study till date, has tried these muscle conditioning and retraining exercises on the denture seeking elderly patients as a preventive measure which may lead to the encouraging results. Hence the need for the study was felt. Keeping this aspect in mind, the present randomized controlled study will be conducted to analysis the effect of muscle conditioning and retraining exercises on denture wearing elderly patients by EMG and Bite force analysis.  

 

NULL HYPOTHESIS:

There exists no difference in the EMG activity and Bite force of masseter, buccinators, orbicularis oris and temporalis muscles in complete denture patients, with and without giving muscle conditioning and retraining exercises at baseline, 1 month and 2 months of time intervals.

 

 
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