| 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
|
|
|
Primary Sponsor
|
| Name |
Faculty of Dental Sciences |
| Address |
Faculty of Dental Sciences BHU |
| Type of Sponsor |
Government medical 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 |
| 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
|
|
|
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. |