| CTRI Number |
CTRI/2025/02/080884 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on recording vertical and horizontal jaw relation |
|
Scientific Title of Study
|
To evaluate the effect of Transcutaneous Electrical Nerve Stimulation (TENS) on recording vertical and horizontal jaw relations in completely edentulous patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dangar Shyam Maganbhai |
| Designation |
PG Resident |
| Affiliation |
Army Dental Centre Research and Referral |
| Address |
Room 1A, Department of Prosthodontics, Army Dental Centre Research and referral Subroto Park Delhi cantonment New Delhi
New Delhi
DELHI
110010
India |
| Phone |
9725064299 |
| Fax |
|
| Email |
shyamdangar17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col Guruprasad |
| Designation |
PG Resident |
| Affiliation |
Army Dental Centre Research and Referral |
| Address |
Room 1A, Department of Prosthodontics, Army Dental Centre Research and referral Subroto Park Delhi cantonment New Delhi
New Delhi
DELHI
110010
India |
| Phone |
8283817753 |
| Fax |
|
| Email |
guruprasadabs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dangar Shyam Maganbhai |
| Designation |
PG Resident |
| Affiliation |
Army Dental Centre Research and Referral |
| Address |
Room 1A, Department of Prosthodontics, Army Dental Centre Research and referral Subroto Park Delhi cantonment New Delhi
New Delhi
DELHI
110010
India |
| Phone |
9725064299 |
| Fax |
|
| Email |
shyamdangar17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Departmental Equipment Fund, Army Dental Centre Research and Referral, Dhaula Kuan, new Delhi |
|
|
Primary Sponsor
|
| Name |
Army Dental Centre Research and Referral |
| Address |
Army Dental Centre Research and Referral, Dhaula Kuan, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Dangar Shyam Maganbhai |
Army Dental Centre Research and Referral |
Army Dental Centre Research and Referral Subroto Park Delhi Cantonment New Delhi
New Delhi
DELHI |
9725064299
shyamdangar17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army Dental Centre Research and Referral |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with complete edentulism |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vertical and horizontal jaw relation with application of TENS |
TENS will be applied on both masseter regions and vertical and horizontal jaw relations will be recorded, the time required to record vertical and horizontal jaw relations and any change the jaw relation will be evaluated for pre-and post application of TENS |
| Comparator Agent |
Vertical and horizontal jaw relation without application of TENS |
Vertical and horizontal jaw relations will be recorded at baseline without application of TENS |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Healthy persons with good neuromuscular control.
High, well-formed rounded maxillary and mandibular residual ridges.
Class I ridge relation; according to Glossary of Prosthodontic Terms – 9 (GPT-9) the positional relation of the mandibular residual ridge to maxillary residual ridge.
Class I tongue size as per House’s classification.
Patient willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with history of cardiovascular, cerebrovascular and neurological disorders.
Patients with cardiac pacemakers.
Patients on medications which affect muscular and neuromuscular function.
Pendulous, flabby, knife edge and depressed residual alveolar ridges; as it is difficult to stabilize record base against horizontal forces.
Patient having facial hairs (beard) / unshaved; as it will interfere with placement of TENS electrode.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vertical dimension at rest, centric jaw relation |
Baseline, 7 days post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| chairside time taken for recording vertical & horizontal jaw relation |
Baseline 7 days post operativey |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/03/2025 |
| 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="0"
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
|
In this clinical trial we have decided first to record the Vertical and horizontal jaw relations without application of TENS after 7 days we will recall the patient and apply the TENS and than we record the Vertical and horizontal jaw relation to evaluate its effect
|