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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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