| CTRI Number |
CTRI/2025/10/096531 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
“A study to see how facial and chewing muscles change after treatment with dentures or dental implants.”
|
|
Scientific Title of Study
|
Ultrasonographic and Electromyographic assessment of muscle characteristics post rehabilitation with complete denture and implant (UEMC): A prospective study |
| Trial Acronym |
UEMC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishan Kant Sharma |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Dental Sciences, IMS BHU |
| Address |
Faculty of Dental Sciences, IMS BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9958204418 |
| Fax |
|
| Email |
krishansharmaji522@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Romesh Soni |
| Designation |
Professor |
| Affiliation |
Unit of prosthodontics Faculty of Dental Sciences, IMS BHU |
| Address |
Room no 4 , 2nd floor Faculty of Dental Sciences,IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9616803332 |
| Fax |
|
| Email |
rsoni80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Romesh Soni |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, IMS BHU |
| Address |
Room no 4, 2nd floor Faculty of Dental Sciences,IMS BHU
UTTAR PRADESH
221005
India |
| Phone |
9616803332 |
| Fax |
|
| Email |
rsoni80@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Faculty of dental sciences ims bhu |
| Address |
Faculty of dental sciences ims bhu - 221005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Krishan Kant Sharma |
Faculty of Dental Sciences , sir sundarlal hospital |
Room no 4 2nd floor Faculty of dental sciences ims bhu
Varanasi
UTTAR PRADESH |
9958204418
krishansharmaji522@gmail.com |
| Krishan Kant Sharma |
Faculty of Modern Medicine sir sundarlal hospital |
Room no 14 , Sir Sunderlal Hospital, Banaras Hindu University
Varanasi
UTTAR PRADESH |
9958204418
krishansharmaji522@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Edentulousness |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Prosthodontic rehabilitation |
Prosthodontic rehabilitation using complete dentures |
| Intervention |
Prosthodontic rehabilitation |
Prosthodontic rehabilitation using implants |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy.
Non-smokers.
Edentulous individuals who were at least 1 months and a maximum 6 months edentulism.
Edentulous individuals who have never used prosthesis before.
No contraindications to implant placement
|
|
| ExclusionCriteria |
| Details |
Patients with history of any chronic illness (any systemic disease)
Tobacco intake (smoke or smokeless) or any other substance abuse.
Temporomandibular disorders.
History of undergoing surgical procedures involving facial muscles or muscles of mastication.
Irradiation in the head and neck area.
Patients with poor oral hygiene.
Pregnant patients.
Active chemotherapy or active radiotherapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess changes in muscle thickness in completely edentulous patients rehabilitated with complete dentures and implants using ultrasonography (USG) after 3 months and 6
months
2. To assess changes in muscle electrical activity in completely edentulous patients rehabilitated with complete dentures and implants using electromyography(EMG) after 13 weeks and 26 months |
1. To assess changes in muscle thickness in completely edentulous patients rehabilitated with complete dentures and implants using ultrasonography (USG) after 3 months and 6 months
2. To assess changes in muscle electrical activity in completely edentulous patients rehabilitated with complete dentures and implants using electromyography(EMG) 13 weeks and 26 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
16/11/2025 |
| 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 Applicable |
| 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
|
This study aims to evaluate changes in masseter and temporalis muscle thickness and electrical activity in completely edentulous patients rehabilitated with complete dentures and implant-supported prostheses using ultrasonography and electromyography. Complete edentulism reduces muscle thickness and impairs mastication, whereas implant prostheses provide superior support, enhancing bite force, chewing efficiency, and neuromuscular activity. Although literature supports these benefits, comprehensive comparisons between dentures and implants remain limited. The present prospective in vivo study will include twelve patients assessed at baseline, three months, and six months post-rehabilitation. Statistical analysis will compare outcomes to determine the relative effectiveness of dentures and implants in restoring muscle characteristics. |