| CTRI Number |
CTRI/2025/09/095318 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing tooth pain relief after using herbal gel and laser. |
|
Scientific Title of Study
|
Comparative evaluation of the effect of acmella oleracea topical gel and Low level laser therapy on pulpal pain alleviation-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 |
shashikant |
| Designation |
post graduate student |
| Affiliation |
Coorg Institute of dental sciences |
| Address |
Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no.7 K K campus maggula Virajpete Kodagu Karnataka
Kodagu KARNATAKA 571218 India |
| Phone |
8095368514 |
| Fax |
|
| Email |
shashikulkarni4582@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
shashikant |
| Designation |
post graduate student |
| Affiliation |
Coorg Institute of dental sciences |
| Address |
Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no.7 K K campus maggula Virajpete Kodagu Karnataka
Kodagu KARNATAKA 571218 India |
| Phone |
8095368514 |
| Fax |
|
| Email |
shashikulkarni4582@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K C Ponnappa |
| Designation |
PROFESSOR & HOD |
| Affiliation |
Coorg Institute of dental sciences |
| Address |
Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no.7 K K campus maggula Virajpete Kodagu Karnataka
Kodagu KARNATAKA 571218 India |
| Phone |
9449764068 |
| Fax |
|
| Email |
drponnappa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg institiute of dental science department of conservative dentistry and endodontics maggula virajpete kodagu karnataka pin 571218 India |
|
|
Primary Sponsor
|
| Name |
shashikant |
| Address |
Coorg Institute of dental sciences Department of conservative dentistry and endodontics room no 7 K K campus maggula virajpete kodagu karnataka |
| 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 Shashikant |
Coorg institute of dental sciences |
Department of conservative dentistry and endodontics Room no.7 K K campus maggula Virajpete Kodagu Karnataka Kodagu KARNATAKA |
08095368514
shashikulkarni4582@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION REVIEW BOARD, COORG INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients in good health with symptomatic reversible pulpitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acmella oleracea gel |
one time intervention by applying acmella oleracea gel on the cleaned surface of permanent tooth of intrest with deep dentinal caries and evaluate the analgesic effect |
| Comparator Agent |
colgate pain out gel |
Applying colgate pain out gel on the cleaned surface of permanent tooth of intrest with deep dentinal caries and evaluate the analgesic effect |
| Intervention |
low level laser |
one time intervention by photodynamic therapy with diode laser(640nm) for 30s (2 cycles) with low level laser tip over the apical region of the permanent tooth of intrest with deep dentinal caries and evaluate analgesic effect |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with good health in the age group of 20-70 years. Patients with symptomatic reversible pulpitis with deep dentinal caries. Patients with remaining dentin thickness at least 1-1.5mm on radiograph. Patients with preoperative pain score greater than 3 as measured on VAS scale.
|
|
| ExclusionCriteria |
| Details |
Individuals with systemic and mental illness.
Individuals with pain from multiple soft tissue or hard tissue sites.
Pregnant and lactating mothers.
Individuals who have taken short acting systemic or topical analgesics within 120 minutes before the dental visit or any long-acting systemic analgesics within 240 minutes before the dental visit. Presence of chronic endodontic lesions in relation to the tooth.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluvate the analgesic effect during administration of acmella oleracea gel and low level laser therapy. |
Evaluvate the analgesic effect during administration of acmella oleracea gel and low level laser therapy within 120 minutes of application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intergroup comparison of analgesic effect |
compare the analgesic effect within 40 minutes |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/10/2025 |
| Date of Study Completion (India) |
03/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Pain is one of the
most common symptoms in the dental practice. Many authors have focused on pain
and how to alleviate it. Herbal medications have shown tremendous scope in
medical and dental practice without the side effects of the commonly prescribed
and used pharmaceutical drugs. An essential medicinal plant, Acmella oleracea is found in tropical and subtropical regions, primarily
in India and South America. It is commonly referred to as the "toothache
plant," as it may both stimulate salivation and lessen the discomfort
associated with toothaches. Various extracts and active metabolites from
various sections of this plant possess valuable pharmacological activities.
Jambu, the traditional name for Acmella, has been used for centuries to treat
oral pain because of its analgesic properties.
The antinociceptive
effects has been demonstrated and are related to different processes, including
inhibition of prostaglandin synthesis, activation of opioidergic,
serotoninergic and GABAergic systems, and anesthetic activity through blockage
of voltage-gated Na channels. Acmella oleracea represents a promising future in
pain management. Since they are easily accessible, have a long history of
proven usefulness, and are safe to use in treating oral or dental issues
without having the systemic negative effects associated with pharmaceutical
preparations, herbal remedies have long been a highly popular choice for
self-medication. The current assessment focuses on the use of a herbal drug in
the form of gel for the management of dental pain of endodontic origin.
An additional area of
interest in this field is the use of Low-Level Laser Therapy to achieve an
analgesic effect in the dental pulp prior to restorative procedures. First
noted with the Nd:YAG Laser in the early 1990’s, the clinical use of
’pre-emptive Laser analgesia’ is becoming more widespread now as a clinical
technique. The action of this type of Low-Level Laser Therapy is to cause a
disruption in the action of the Na-K pump in the cell membrane, resulting in a
loss of impulse conduction, and thus an analgesic effect is produced. The
ability of Low-Level Laser Therapy to exert analgesic effects has historically
been a major clinical application of the technique. In vivo studies of the
analgesic effect of Low-Level Laser Therapy on nerves supplying the oral cavity
have demonstrated that Low-Level Laser Therapy decreases the firing frequency
of nociceptors.
Hence, the purpose of this study is to compare and evaluate the use
of an herbal gel containing Acmella oleracea and Low-Level Laser Therapy for
the management of dental pain of endodontic origin. |