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CTRI Number  CTRI/2023/10/058618 [Registered on: 13/10/2023] Trial Registered Prospectively
Last Modified On: 11/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Management of pain after root canal treatment using cold saline and laser 
Scientific Title of Study   COMPARATIVE EVALUATION OF CRYOTHERAPY AND LOW LEVEL LASER THERAPY ON POST ENDODONTIC PAIN MANAGEMENT -A RANDOMIZED CLINICAL TRAIL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  YAZHISAI P 
Designation  PG student 
Affiliation  RVS Dental College and Hospital 
Address  Department of conservative dentistry and endodontics, RVS Dental College And Hospital, Kumaran kottam campus, kannampalayam, Sulur

Coimbatore
TAMIL NADU
641402
India 
Phone  9944396337  
Fax    
Email  yazhisai1909@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  VINAY KUMAR G 
Designation  PROFESSOR AND HOD 
Affiliation  RVS Dental College and Hospital 
Address  Department of conservative dentistry and endodontics RVS Dental College And Hospital Kumaran Kottam Campus Kannampalayam Sulur

Coimbatore
TAMIL NADU
641402
India 
Phone  9886217487  
Fax    
Email  gvink74@gmail.com  
 
Details of Contact Person
Public Query  
Name  YAZHISAI P 
Designation  PG student 
Affiliation  RVS Dental College and Hospital 
Address  Department of conservative dentistry and endodontics RVS Dental College And Hospital Kumaran Kottam Campus Kannampalayam Sulur

Coimbatore
TAMIL NADU
641402
India 
Phone  9944396337  
Fax    
Email  yazhisai1909@gmail.com  
 
Source of Monetary or Material Support  
RVS DENTAL COLLEGE AND HOSPITAL, KUMARAN KOTTAM CAMPUS, KANNAMPALAYAM, SULUR 641402 
 
Primary Sponsor  
Name  Yazhisai P 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, RVS DENTAL COLLEGE AND HOSPITAL, KUMARAN KOTTAM CAMPUS, KANNAMPALAYAM, SULUR. 641402 
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 P YAZHISAI  RVS dental college and hospital  Room No 7b,Department of conservative dentistry and endodontics RVS Dental College and Hospital kumaran kottam campus kannampalayam sulur 641402
Coimbatore
TAMIL NADU 		 9944396337

yazhisai1909@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RVS INSTITUTIONAL ETHICS COMMITEE  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 
Intervention  CRYOTHERAPY  As final irrigation, the root canals will be irrigated with normal saline at a temperature of 2.5°C for 5 mins (20ml) 
Intervention  INTRACANAL LASER APPLICATION  DIODE LASER(970+/-15nm)- output power of 2.4 W and energy of 12 J (each cycle) in the pulsed mode (pulse duration: 20 μs), irradiation for 10 s, followed by a 10-s pause, which comprised one cycle. This cycle will be applied four times to each root canal.The root canals will be then slowly (at a speed of 2 mm/s) irradiated from the apical to coronal using a continuous circling movement touching the dentinal walls in one cycle for each power. 
Intervention  LOW LEVEL LASER THERAPHY  970+/-15 nm diode laser,0.5 W, around the apex of the root for 30 seconds buccally & lingually 
Comparator Agent  root canal treatment with conventional final irrigation protocol.  In the control group, final irrigation will be performed using 5 mL of 17% EDTA solution for 1 min and 5.25% NaOCl for 1 min followed by 5 mL of 0.9% physiological saline solution at room temperature. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Maxillary anterior and mandibular premolars with completely formed apex with a single canal. 
 
ExclusionCriteria 
Details  1. Patients with allergic reactions to local anesthetics, NSAIDs, NaOCl
2. Patients who had taken analgesics within the last 3 days
3. Previous root canal treatment
4. Severe periodontal disease
5. Periapical cyst or granuloma
6. Swelling

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
REDUCTION IN POST-OPERATIVE PAIN SCORES (VAS SCALE)   6 HOURS
 
 
Secondary Outcome  
Outcome  TimePoints 
REDUCTION IN POST-OPERATIVE PAIN SCORES (VAS SCALE)   24 hours
48 hours
72 hours
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   01/11/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 02-02-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is a randomized, parallel-group, multiple-arm trial comparing the efficacy of cryotherapy, low-level laser therapy, and laser root canal treatment in reducing post-endodontic pain in 40  patients with irreversible symptomatic pulpitis. Using the VAS scale, the primary outcome measure will be a reduction in post-endodontic pain at 6 hours. The secondary outcome will be a reduction in post-endodontic pain at 24,48,72 hours.

 
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