| CTRI Number |
CTRI/2024/12/078537 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EVALUATION OF PAIN ASSESSMENT USING A NEUROMODULATION DEVICE AFTER SEPARATOR PLACEMENT: AN IN-VIVO STUDY |
|
Scientific Title of Study
|
EVALUATION OF PAIN ASSESSMENT USING A NEUROMODULATION DEVICE AFTER SEPARATOR PLACEMENT: AN IN-VIVO 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 |
RAHUL YADAV |
| Designation |
PG STUDENT |
| Affiliation |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
Department of Orthodontics , room no. 4 , Sudha Rustagi College of Dental Sciences and research, Faridabad, Sector 89 , Kheri mor
Adore Smriddhi , sector 89 , faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9654339744 |
| Fax |
|
| Email |
drrahulyadav420@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAHUL YADAV |
| Designation |
PG STUDENT |
| Affiliation |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
Department of Orthodontics , room no. 4, Sudha Rustagi College of Dental Sciences and research, Faridabad, Sector 89 , Kheri mor
Adore Smriddhi sector 89 Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9654339744 |
| Fax |
|
| Email |
drrahulyadav420@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAHUL YADAV |
| Designation |
PG STUDENT |
| Affiliation |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
Department of Orthodontics , room no. 4,Sudha Rustagi College of Dental Sciences and research, Faridabad, Sector 89 , Kheri mor
Adore smriddhi , sector 89 , faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9654339744 |
| Fax |
|
| Email |
drrahulyadav420@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sudha Rustagi College of Dental Sciences and research, Faridabad, Sector 89 , Kheri mor |
|
|
Primary Sponsor
|
| Name |
Rahul Yadav |
| Address |
Department of orthodontics
, Sudha Rustagi College of Dental Sciences and research, Faridabad, Sector 89 , Kheri mor , 121002 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| RAHUL YADAV |
Sudha Rustagi College Of Dental Sciences And Research |
Faridabad , Sector 89
Faridabad
HARYANA |
9654339744
drrahulyadav420@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTSITUTIONAL ETHICS COMMITTEE , SRCDSR-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U07||, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with completely erupted upper first and second molars and compact interproximal contact areas on both upper first molars with healthy periodontal conditions1.
2. Patients with good oral health.
3. Patients ranging from the age of 12 to 24 years are selected for the study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant patients.
2. Patients with the history of seizures, cardiac arrythmia or pacemaker treatment.
3. Patients who were taking any over the counter or prescription pain medication during the testing period.
4. Interproximal caries or restoration
5. Extracted or missing teeth
6. Periodontally compromised teeth
7. Orofacial pain
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Perception and Assessment Using Wong Baker And Numeric Rating Scale |
2 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain Perception Is Minimum In Experimental Group |
2 Days |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
02/01/2025 |
| 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="0"
Months="0"
Days="14" |
|
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
prospective split mouth study, 2 quadrants of the patient’s mouth having randomly assigned into Experimental and
Control groups.To investigate patient discomfort after separator
placement during orthodontic treatment, patients will be treated with a split-mouth design where one
side of the arch will be treated with neuromodulation device with on mode (Experimental group) and the other half of the arch with just mechanical
application of the device with no current (Control group) . During the whole
process, the patient will not be aware that in which side of the mouth the
device will be used with on mode and which side with no current.
The device will be switched on by pressing the
single press button. A blue light will be seen that will stay on for 1 second
which means the device is powered on. Once the blue light starts blinking, the
device will be ready to use. Will place the two metal probes on the gingival area
of the tooth visualizing the roots of the tooth for 20 seconds. Device movement
will be done both in horizontal and vertical direction gently for 20 seconds
each.
The patient
will be asked to rate the intensity of pain after neuromodulation device application immediately after placement of
separators then after 4 hours , 24 hours and 48 hours on a Wong-Baker smiley
scale and Numeric Rating Scale (NRS) |