FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096535 [Registered on: 28/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “Comparing Bite Force and Masticatory Muscle Activity in Two- and Three-Implant Supported Mandibular Overdentures” 
Scientific Title of Study   Bite Force and Muscle Activity in Two- vs. Three-Implant Mandibular Overdentures (TIMOD): A Comparative 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  Sayani Podder 
Designation  Junior Resident 
Affiliation  Faculty of Dental Sciences, BHU 
Address  Room no 4, Unit of Prosthodontics And Crown And Bridge, Faculty of Dental Sciences ,Institute of Medical Sciences, BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  9903582383  
Fax    
Email  sayanipodder45@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankita Singh 
Designation  Professor and Guide 
Affiliation  Faculty of Dental Sciences, BHU 
Address  Room no 4, Unit of Prosthodontics And Crown And Bridge, Faculty of Dental Sciences ,Institute of Medical Sciences, BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  9794243771  
Fax    
Email  ankita.singh2@bhu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ankita Singh 
Designation  Professor and Guide 
Affiliation  Faculty of Dental Sciences, BHU 
Address  Room no 4, Unit of Prosthodontics And Crown And Bridge, Faculty of Dental Sciences ,Institute of Medical Sciences, BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  09794243771  
Fax    
Email  ankita.singh2@bhu.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Faculty of Dental Sciences 
Address  Faculty of Dental Sciences BHU 
Type of Sponsor  Government medical college 
 
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 
Sayani Podder  Institute of Medical Sciences, Banaras Hindu University  Unit of Prosthodontics And Crown And Bridge, Faculty of Dental Sciences Banaras Hindu University 221005
Varanasi
UTTAR PRADESH 
09903582383

sayanipodder45@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PLACING 2 IMPLANT IN MANDIBULAR OVERDENTURE   Placing 2 implants in mandibular overdenture and checking bite force and masticatory muscle efficiency before implant placement and after implant placement and loading  
Comparator Agent  PLACING 3 IMPLANT MANDIBULAR OVERDENTURE  Placing 3 implants in mandibular overdenture and checking bite force and masticatory muscle efficiency before implant placement and after implant placement and loading. This study will evaluate and compare muscle activity and bite force distribution between 1) conventional complete denture and two implant supported mandibular over denture 2) conventional complete denture and three implant supported mandibular over denture and 3) two and three mandibular implant supported groups. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Edentulous maxilla and mandibles with adequate bone volume requiring implant-supported mandibular over-dentures opposing conventional maxillary complete denture(as confirmed by CBCT/3D imaging)
Good general health without contraindications for implant surgery
Willing to report for follow-up visits.
No acute infection.
Informed and signed consent.
 
 
ExclusionCriteria 
Details  1)Patients with history of
A)Tobacco intake (smoke or smokeless) or any other substance abuse.
B)Temporomandibular disorders.
C)Irradiation in the head and neck region.
Patients with para functional habits (bruxism or clenching)
2)Pregnant patients.
3)Active chemotherapy or active radiotherapy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To investigate the differences in masticatory muscle activity and force distribution between two-implant and three-implant-supported mandibular over dentures opposing maxillary complete denture.
 
AT 1,3 AND 6 MONTH 
 
Secondary Outcome  
Outcome  TimePoints 
This study will evaluate and compare muscle activity, bite force distribution and chewing efficiency between
1) conventional complete denture and two implant supported mandibular over denture
2) conventional complete denture and three implant supported mandibular over denture and
3) two and three mandibular implant supported groups.
 
AT 1,3 AND 6 MONTH 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/11/2025 
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 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  

Edentulism, the complete loss of teeth, affects over 30% of the global population, particularly the elderly, leading to impaired mastication, decreased muscle activity, and reduced quality of life. Conventional complete dentures, though widely used, often provide inadequate stability and retention—especially in the mandibular arch—resulting in patient discomfort and inefficient chewing. Implant-supported overdentures have emerged as a superior alternative, offering improved support, retention, stability, and bone preservation, while enhancing aesthetics and psychological well-being. The McGill Consensus (2002) and New York Consensus (2009) endorse mandibular implant-supported overdentures as the standard of care for edentulous patients. Two-implant overdentures significantly enhance masticatory efficiency and muscle coordination, whereas three-implant overdentures further improve prosthesis stability, reduce screw loosening, and minimize crestal bone loss. This study aims to compare masticatory muscle activity and bite force distribution between two- and three-implant-supported mandibular overdentures using electromyography (EMG) and bite force assessments. Following fabrication of conventional dentures, baseline EMG, bite force, and chewing efficiency will be recorded, followed by implant placement and subsequent evaluations at 1, 3, and 6 months. The findings will provide insight into how implant number influences muscle performance, bite dynamics, and functional efficiency in edentulous patients.

 
Close