| 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
|
|
|
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
|
|
|
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. |