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CTRI Number  CTRI/2025/02/080023 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Evaluating the Wavelengths of Laser for managing pain after single sitting Root Canal treatment 
Scientific Title of Study
Modification(s)  
Comparative Evaluation Of Photobiomodulatory Effect Of 660nm and 970nm Diode Laser On PostOperative Pain Management In Single Visit Endodontic Treatment A Randomized Control 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  Dr Priyankar Roy 
Designation  Postgraduate Student 
Affiliation  KAHER KLE Vishwanath Katti Institute Of Dental Sciences 
Address  Department Of Conservative Dentistry And Endodontic, KAHER KLE Vishwanath Katti Institute Of Dental Sciences, JNMC Campus, Nehru Nagar, Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  7975161191  
Fax    
Email  roypriyankar09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyankar Roy 
Designation  Postgraduate Student 
Affiliation  KAHER KLE Vishwanath Katti Institute Of Dental Sciences 
Address  Department Of Conservative Dentistry And Endodontic, KAHER KLE Vishwanath Katti Institute Of Dental Sciences, JNMC Campus, Nehru Nagar, Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  7975161191  
Fax    
Email  roypriyankar09@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonal B Joshi 
Designation  Professor and Dean 
Affiliation  KAHER KLE Vishwanath Katti Institute Of Dental Sciences 
Address  Department Of Conservative Dentistry And Endodontic, KAHER KLE Vishwanath Katti Institute Of Dental Sciences, JNMC Campus, Nehru Nagar, Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  07975161191  
Fax    
Email  jsonal70@yahoo.co.in  
 
Source of Monetary or Material Support
Modification(s)  
KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India 
 
Primary Sponsor  
Name  PRIYANKAR ROY 
Address  Department number 7, Department of Conservative Dentistry and Endodontics, second floor, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar Belgaum KARNATAKA 590010 
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 Priyankar Roy  KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar  Department Of Conservative Dentistry And Endodontic, KAHER KLE Vishwanath Katti Institute Of Dental Sciences, JNMC Campus, Nehru Nagar, Belgaum
Belgaum
KARNATAKA 
7975161191

roypriyankar09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No wavelength exposure  No photobiomodulation done after Root Cannal treatment 
Intervention  Photobiomodulation with 660nm Wavelength Diode Laser  Post operative pain evaluation after Root canal treatment using Photobiomodulation therapy with 660nm laser at 100mW Power exposure for 60 sec palatally and bucally, respectively.  
Intervention  Photobiomodulation with 970nm Wavelength Diode Laser  Post operative pain evaluation after Root canal treatment using Photobiomodulation therapy with 970nm laser at 200mW Power exposure for 60 sec palatally and bucally, respectively.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients requiring root canal treatment of maxillary 1st premolar teeth with two root canals, diagnosed clinically as asymptomatic irreversible pulpitis using pulp sensitivity tests.
2.Patients ranging in the age group of 18-50 years.
3.Patients with non-contributory medical history.
4.Teeth with adequate coronal structure to ascertain proper isolation.
 
 
ExclusionCriteria 
Details  PATIENT-SPECIFIC:
1.Patients who refuse to consent to the procedure.
2.Patients with any systemic diseases, pregnancy, or immunocompromised conditions.
3.Patients on any antibiotic therapy in the past 3 months
4.Patients on any analgesic drugs in the past 7 days
5.Patients allergic to lignocaine in 1:1,00,000 concentration adrenaline
6.Patients requiring root canal treatment of two or more teeth ipsilaterally (since the pain caused by any of these teeth can result in false positive reading)

B. SPECIFIC TO DIAGNOSIS:
1.Teeth with acute apical periodontitis
2.Teeth with acute periapical abscess
3.Teeth with an inflammatory exudate draining through the canal.
4.Necrotic painful teeth with absence of sinus tract for drainage
5.Re-treatment cases
6.Anatomically complicated tooth
7.Teeth with aggressive periodontitis or grade III mobility
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and conduct an intragroup and intergroup comparison of the intensity & incidence of post-operative pain at 6, 24, 48 and 72 hours using Visual analog scale without performing photo-biomodulation,with performing photobiomodulation with 660nm and 970nm wavelengths  6, 24, 48 and 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate & compare the association of
variables (age & sex) between groups 
6 24 48 & 72 hours 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="27" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/02/2025 
Date of Study Completion (India) 12/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 after endodontic treatment is the biggest fear of an Endodontist and is a common complication, which affects approximately 3-58% of patients . The etiology of postoperative endodontic pain is multifactorial, generally induced by inflammatory mediators produced due to chemical, mechanical, or microbial injuries to the pulp & periapical tissues that result in acute inflammation. While analgesic remains a popular form of therapy, lasers can be proposed as an alternate yet competent form of pain management due to their evident side effects.

 Low-level laser therapy (LLLT) or Photobiomodulation has shown a comparable effect over NSAIDs in pain management as per studies. While photobiomodulation can be done in the 600nm - 1000nm wavelength range previous studies have been done with 970nm & a few studies with 640nm wavelength in root canal treatment and re-treatment cases.

Different laser parameters such as wavelength, power, duration, and frequency could provide different reduced pain intensity results and certain wavelengths can be more effective than others in managing post-operative pain .

According to the literature, there is no evidence on which wavelength of the Diode laser is more efficient & safer way of reducing post-operative pain for patients who require endodontic treatment. Hence the present study is designed to evaluate and compare the efficacy of photobiomodulatory effect with 660nm and 970nm wavelength of diode lasers in single visit endodontic treatment.

 
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