| CTRI Number |
CTRI/2026/02/103603 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [Laser activation of LI4 (Hegu) acupoint] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of laser activation on LI4 (Hegu) point for the patients undergoing root canal treatment |
|
Scientific Title of Study
|
Effect of laser activation of LI4 (Hegu) point on the inferior alveolar nerve block for mandibular molars with symptomatic irreversible pulpitis – a randomised controlled clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sankar Vishwanath |
| Designation |
Senior Lecturer |
| Affiliation |
KSR Institute of Dental science and Research |
| Address |
Department of Conservative Dentistry and Endodontics, KSR Institute of Dental science and Research, KSR kalvi nagar, Tiruchengode.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9042050014 |
| Fax |
|
| Email |
sankaravg@ksridsr.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sankar Vishwanath |
| Designation |
Senior Lecturer |
| Affiliation |
KSR Institute of Dental science and Research |
| Address |
Department of Conservative Dentistry and Endodontics, KSR Institute of Dental science and Research, KSR kalvi nagar, Tiruchengode.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9042050014 |
| Fax |
|
| Email |
sankaravg@ksridsr.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sankar Vishwanath |
| Designation |
Senior Lecturer |
| Affiliation |
KSR Institute of Dental science and Research |
| Address |
Department of Conservative Dentistry and Endodontics, KSR Institute of Dental science and Research, KSR kalvi nagar, Tiruchengode.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9042050014 |
| Fax |
|
| Email |
sankaravg@ksridsr.edu.in |
|
|
Source of Monetary or Material Support
|
| KSR Institute of Dental science and Research, KSR Kalvi Nagar, Kuchipalayam PO, Tiruchengode, Namakkal District, Tamil Nadu, INDIA. 637215 |
|
|
Primary Sponsor
|
| Name |
Sankar Vishwanath |
| Address |
KSR Institute of Dental science and Research, KSR Kalvi Nagar, Kuchipalayam PO, Tiruchengode, Namakkal District, Tamil Nadu, INDIA. 637215 |
| 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 |
| Dr Sankar Vishwanath |
KSR Institute of Dental science and Research |
Department of Conservative Dentistry and Endodontics, 3rd Floor, Room number 7.
Namakkal
TAMIL NADU |
9042050014
sankaravg@ksridsr.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSRIDSR INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LOW LEVEL LASER ACTIVATION |
Low level laser activation on LI4 point with Diode laser with following parameters: Power output 0.2 to 1 W, Wavelength 660nm, Energy 4J, non-contact mode 2-3 mm away from tissue creating a 3-5mm spot size. Operated in a defocussed continuous wave mode. |
| Comparator Agent |
SHAM LASER ACTIVATION |
Pretend to activate the LI4 point with Diode laser in OFF
mode. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with mild or no systemic diseases according to ASA physical status classification (Class 1 and 2). The patient with moderate to severe (more than or equal to 66) pain prior to the procedure scored using a visual analog scale. Patient diagnosed with symptomatic irreversible pulpitis in mandibular first or second molar that will be confirmed with cold test and electric pulp testing. Radiographic confirmation of caries involving pulp and devoid of any periapical changes. History of spontaneous pain or nocturnal pain. |
|
| ExclusionCriteria |
| Details |
Patients who had taken any analgesics or systemic steroids in the past 24 hours at the time of intervention. Patients allergic to local anesthetic or other NSAIDS. Patients under opioids, antidepressants and other medications for mental disorders. Pregnant & breast-feeding women. History of gastrointestinal tract related disease, metabolic and hormonal disorders. Teeth with periodontal disease, non-restorable tooth structure loss, and radiographic observations like break in lamina dura and periapical radiolucency. Patients with history of any other painful orofacial diseases. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Success of IANB will be assessed using VAS scores (subjective measure) and the scores given by blinded observers in SEM scale (objective measure). |
One time assessment of pain score immediately after the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulse rate, respiratory rate & SpO2 values. |
Assessment of Pulse rate, respiratory rate & SpO2 values during the procedure & immediately after the procedure. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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="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
|
It frequently becomes difficult to achieve pulpal anesthesia in teeth with symptomatic irreversible pulpitis. Acupressure is an integral part of many non-pharmacological pain management techniques implemented during root canal therapy. The most common application of laser activation at acupressure points is to reduce pain during dental procedures. The study aims to assess the effect of low level laser activation on LI4 (Hegu) acupressure point in enhancing the success rate of inferior alveolar nerve block. In addition, it is expected to help reduce the patients’ anxiety levels while they receive root canal therapy along with LI4 laser activation. |