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CTRI Number  CTRI/2021/05/033802 [Registered on: 25/05/2021] Trial Registered Prospectively
Last Modified On: 18/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARATIVE EVALUATION OF PAIN AFTER ROOT CANAL TREATMENT WITH TWO DIFFERENT TECHNIQUES FOLLOWED BY USING LASERS FOR DISINFECTION OF ROOT CANALS 
Scientific Title of Study   COMPARISON OF POST-OPERATIVE PAIN USING TWO INSTRUMENTATION TECHNIQUES FOLLOWED BY LASER IRRADIATION IN NON-VITAL TEETH WITH SYMPTOMATIC APICAL PERIODONTITIS: A RANDOMIZED CONTROLLED TRIAL  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreya Shivangi 
Designation  PG STUDENT  
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi MumbaI 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614

Mumbai
MAHARASHTRA
400614
India 
Phone  8310270967  
Fax    
Email  shivangi.shreya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Jain 
Designation  Head of Department 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614

Mumbai
MAHARASHTRA
400614
India 
Phone  9869152905  
Fax    
Email  drakjain5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreya Shivangi 
Designation  PG STUDENT 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614

Mumbai
MAHARASHTRA
400614
India 
Phone  8310270967  
Fax    
Email  shivangi.shreya@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai  
Dr Shreya Shivangi  
 
Primary Sponsor  
Name  Dr Shreya Shivangi 
Address  Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 
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 Shreya Shivangi  Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai   Room no 302, 3rd floor Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
8310270967

shivangi.shreya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Symptomatic Apical periodontitis 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laser therapy along with continuous rotary instrumentation  Biomechanical preparation will be done using Pro HS niti rotary files following which Biolase EpicX laser (940nm wavelength, 50/60 Hz frequency in pulsed mode) with attached laser tip of 200µm diameter will be placed in the root canal 2mm short of apex. An irradiation of 5 sec followed by a 10 sec pause will be performed 4 times. 
Intervention  Laser therapy along with engine driven reciprocating handpiece instrumentation.   K-Flex files will be used for biomechanical preparation using k-400 reciprocating handpiece following which Biolase EpicX laser (940nm wavelength, 50/60 Hz frequency in pulsed mode) with attached laser tip of 200µm diameter will be placed in the root canal 2mm short of apex. An irradiation of 5 sec followed by a 10 sec pause will be performed 4 times.  
Comparator Agent  Nil  N.A. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects older than 18 years of either gender.
Subjects having a single rooted non-vital tooth with symptomatic apical periodontitis needing primary endodontic treatment.
Cooperative health subjects who are willing to participate in the study and sign the consent form 
 
ExclusionCriteria 
Details  -Subjects with uncontrolled systemic diseases or allergies.
-History of previous root canal treatment.
-Presence of swelling or sinus tracts.
-Presence of severe periodontal disease.
-Periapical radiolucency.
-Subjects who’ve taken analgesics within the last 3 days.
-Subjects allergic to local anesthesia.
-Subjects unwilling to sign the consent form 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative pain scores   Baseline, 24 hrs, 48 hrs and 72 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Percussion pain scores  Pre-operative percussion pain score and post - operative percussion pain score (at 72 hours) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2021 
Date of Study Completion (India) 29/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

    Pain management is one of the most important aspects of endodontic treatment. Infected root canals are the most common cause of endodontic pain. Apical extrusion of debris is a drawback of all endodontic instrumentation techniques. This can result in post-operative pain and discomfort due to inflammation of periapical tissues. It is generally accepted that crown down technique and balanced force technique cause less apical extrusion of debris and hence lesser post-operative pain. In earlier studies related to lasers, the use of lasers was limited to treating dentinal hypersensitivity, for its effects on vital pulpotomy, and for evaluating postoperative pain and swelling in patient undergoing extractions of impacted 3rd molar. Use of lasers after chemo-mechanical preparation have been shown in some studies to affect pain outcomes favourably. However, the crown down technique for NiTi has several drawbacks such as file breakage, poor dentin conservation (predisposing to vertical root fractures) and high recurring cost. According to our literature search, post-operative pain due to debris extrusion with k400 reciprocating handpiece for hand files using step back technique has never been compared with NiTi rotary instrumentation using crown down technique. Also, to the best of our knowledge, Biolase EpicX, K400 Reciprocation Handpiece, and Pro HS Niti Rotary systems have not been used in the investigations for the same. Therefore, this clinical study proposes to investigate the incidence of post-operative pain following chemo-mechanical preparation of single rooted teeth having symptomatic apical periodontitis using rotary instrumentation with Pro HS file system and engine driven reciprocating instrumentation with K-flex files along with laser irradiation (by Biolase EpicX).

 
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