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CTRI Number  CTRI/2025/11/097786 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 20/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Low-Level Laser Therapy vs Intracanal Cryotherapy: Managing Pain After Single Visit Root Canal Treatment in Lower Molars 
Scientific Title of Study   Comparing the Effect of Low Level Laser Therapy and Intracanal Cryotherapy on Post Operative Pain following Single-Visit Nonsurgical Endodontic Treatment of Mandibular Molars with Irreversible Pulpitis and Apical Periodontitis a Randomized 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  Manali Jagtap 
Designation  PG Student 
Affiliation  Manubhai Patel Dental College and Hospital 
Address  Manubhai Patel Dental College and Hospital, Department of Conservative Dentistry, Aesthetics and Endodontics

Vadodara
GUJARAT
390011
India 
Phone  09099778622  
Fax    
Email  jagtapmanali1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ankit Arora 
Designation  Professor 
Affiliation  Manubhai Patel Dental College and Hospital 
Address  Manubhai Patel Dental College and Hospital, Department of Conservative Dentistry, Aesthetics and Endodontics

Vadodara
GUJARAT
390011
India 
Phone  9033975629  
Fax    
Email  aroraankit24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manali Jagtap 
Designation  PG Student 
Affiliation  Manubhai Patel Dental College and Hospital 
Address  Manubhai Patel Dental College and Hospital, Department of Conservative Dentistry, Aesthetics and Endodontics

Vadodara
GUJARAT
390011
India 
Phone  09099778622  
Fax    
Email  jagtapmanali1999@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Manali Jagtap 
Address  Manubhai Patel Dental College and Hospital, Department of Conservative Dentistry, Aesthetics and Endodontics  
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 
Manali Jagtap  Manubhai Patel Dental college and Hospital  Department of Conservative Dentistry and Endodontics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011
Vadodara
GUJARAT 
09099778622

jagtapmanali1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Research)   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  Control Group (No Intervention Group)  2) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis without any adjunct therapy 
Intervention  Intracanal Cryotherapy  2) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis in conjunction with Intracanal Cryotherapy 
Intervention  Low Level Laser Therpay  1) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis in conjunction with Low-level Laser Therapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients requiring root canal treatment of mandibular 1st and 2nd molars
2. Patients diagnosed with irreversible pulpitis and or apical periodontitis
3. Teeth with spontaneous pain or lingered by cold or heat
4. Teeth with mature apex
5. Teeth with mobility less than 1mm in either direction
6. PAI Index score of 2 or 3
7. Pre operative tooth and percussion pain of less than 56 mm on a 170 mm visual analogue scale
 
 
ExclusionCriteria 
Details  1. Medically compromised patients (history of pregnancy, malignancy, diabetes mellitus)
2. Patients with other pulpal diagnosis
3. Patients with a history of analgesic intake (antibiotics, NSAIDs, opioids or corticosteroids) during 12 hours prior to treatment
4. Presence of complex anatomy of the root (severe curvature more than 25 degrees)
5. Calcified or obstructed canals on radiographs
6. Very long roots
7. Internal or External root resorption
8. Teeth with open apex
9. Teeth with procedural errors
10. Presence of any defect in the root such as caries, restoration, previously endodontically treated, root resorption, craze lines and fracture
11. Severely damaged teeth
12. Teeth with severe periodontal disease
13. Teeth with periodontal probing depth more than 3 mm
14. Teeth associated with swelling, sinus tract, presence of a radiographic lesion
15. Tooth hypersensitivity to percussion
16. Absence of occlusal contact
17. Absence of palpation sensitivity 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis in conjunction with Low-level Laser Therapy.

2) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis in conjunction with Intracanal Cryotherapy
 
Baseline T0
6 hours T1
12 hours T2
24 hours T3
48 hours T4
72 hours T5 
 
Secondary Outcome  
Outcome  TimePoints 
3) To compare and evaluate the reduction in the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis between Low-level Laser Therapy and Intracanal Cryotherapy   Baseline T0
6 hours T1
12 hours T2
24 hours T3
48 hours T4
72 hours T5  
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/12/2025 
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="1"
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  

This is an in vivo experimental, prospective, double blinded randomized controlled trial. Participants in each group will be allocated by Lottery system. The candidate under supervision will be responsible for providing allocation and division of patients into three groups and save the data until the date of performing the procedure. Group 1 Single-visit root canal treatment followed by Low-level Laser Therapy, Group 2 Single-visit root canal treatment with adjunctive Intracanal Cryotherapy, Group 3 Single-visit root canal treatment followed by neither of the adjunctive modalities (Control group). The outcome assessors and the participants will be blind (double blinded) to the procedure while the operator (the researcher) will not be blinded owing to the difference in the modalities employed for the treatment and variations in the steps involved while performing the procedure. Detailed history would be recorded and subjective and objective assessment of teeth requiring endodontic treatment will be done using 170 mm Heft Parker Visual Analogue Scale. The patient will be explained about the treatment, the alternative treatment and the risks involved and an informed consent will be given to the patient which will be signed by the patient giving the consent. Only the patients giving their consent for the clinical trial will be included in the study and will randomly be divided into three groups (the three groups will be standardized in terms of age, gender, type of tooth, root curvature and severity of pain before treatment) by Lottery method and be scheduled for single-visit root canal treatment. The procedure will be started with administration of local anaesthesia. After achieving adequate anaesthesia, rubber dam isolation will be performed and an access cavity will be prepared using a round bur and high-speed hand-piece under water and air spray. Class 2 cavities will be converted into Class 1 cavities by doing Pre-endodontic build-up. After performing patency filing, the working length of the canals will be determined using Root ZX apex locator (J Morita), which will be confirmed by digital radiography. The root canals will be prepared using Rotary System as per apical constriction and initial binding file and biomechanical preparation will be completed using crown-down method. Standard Irrigation protocol will be followed for all the groups. A final rinse will be performed with saline at room temperature. (Saline at a temperature of 2.5 degree Celsius will be used as a final irrigant in Intracanal Cryotherapy group). The root canals will be dried with sterile paper points and filled with gutta-percha and Bioceramic root canal sealer (Bioactive Root Canal Sealer, Safe Endo) with warm vertical compaction technique (Orikam Fast pack and Fast fill devices) in the same session; the quality of obturation would be checked by taking final Intaoral Periapical Radiographs.  The teeth will be disoccluded and post endodontic restoration will be completed. After the completion of single-visit endodontic procedure following the above mentioned protocol. The first group will be subject to Low-level Laser Therapy by laser irradiation performed using 980-nm diode laser (Rise Medicare) 0.5 W power and a tip diameter of 10 mm for 15 seconds. The laser will be irradiated to the soft tissues covering the mesial and distal apices of the tooth from buccal as well as lingual sides for 15 seconds at each site with the tip of the laser handpiece held at a distance of approximately 10 mm from the mucosa. The fibre tip of the laser will be positioned perpendicular to the surface and close to the soft tissue. The study participants will be assessed for the intensity of pain experienced at 6, 12, 24, 48 and 72 hours postoperatively using a Heft-Parkar visual analogue scale (VAS) and a patient questionnaire which will include the duration to which pain lasted, the number of medications patient had required to take to relieve pain or any other complains related to the tooth, wherein telephonic evaluation of postoperative pain will be done by contacting through phone on specific hours and days and a second appointment will be scheduled for follow-up visit 72 hours post-operatively; when the patient will be assessed clinically to check for intra-oral complications and percussion test will be done to check the periapical status.

 

 
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