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CTRI Number  CTRI/2021/04/032841 [Registered on: 15/04/2021] Trial Registered Prospectively
Last Modified On: 12/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of pain after cleaning and shaping step of root canal treatment in patients with mild or moderate pain due to root canal infection using two types of instruments used for the procedure 
Scientific Title of Study   Comparative evaluation of the effectiveness of rotary and reciprocating single file systems on postoperative pain after biomechanical preparation in patients with chronic apical periodontitis-A randomized clinical 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 POOJA K P 
Designation  JUNIOR RESIDENT DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS 
Affiliation  GOVERNMENT DENTAL COLLEGE KOZHIKODE 
Address  JUNIOR RESIDENT DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS GOVERNMENT DENTAL COLLEGE,KOZHIKODE

Kozhikode
KERALA
673008
India 
Phone  9497071427  
Fax    
Email  laxmipmpooja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR JAYASREE S 
Designation  PROFESSOR AND HOD DEPARTMENT OF CONSERVATIVE DENTISTRY 
Affiliation  GOVERNMENT DENTAL COLLEGE ,KOZHIKODE 
Address  PROFESSOR AND HOD DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS GOVERNMENT DENTAL COLLEGE,KOZHIKODE.KERALA

Kozhikode
KERALA
673008
India 
Phone  9447276940  
Fax    
Email  jsree21@yahoo.in  
 
Details of Contact Person
Public Query  
Name  DR JAYASREE S 
Designation  PROFESSOR AND HOD DEPARTMENT OF CONSERVATIVE DENTISTRY 
Affiliation  GOVERNMENT DENTAL COLLEGE ,KOZHIKODE 
Address  PROFESSOR AND HOD DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS GOVERNMENT DENTAL COLLEGE,KOZHIKODE.KERALA

Kozhikode
KERALA
673008
India 
Phone  9447276940  
Fax    
Email  jsree21@yahoo.in  
 
Source of Monetary or Material Support  
GOVERNMENT DENTAL COLLEGE KOZHIKODE 
 
Primary Sponsor  
Name  DR POOJA KP 
Address  JUNIOR RESIDENT DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS GOVERNMENT DENTAL COLLEGE KOZHIKODE GOVERNMENT MEDICAL COLLEGE CAMPUS,KOZHIKODE.PINCODE-673008 
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 Pooja K P  Department of conservative dentistry and endodontics  Government dental college,Government medical college.P.O,kozhikode
Kozhikode
KERALA 		 9497071427

laxmipmpooja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,GOVERNMENT DENTAL COLLEGE,KOZHIKODE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GROUP 1-RECIPROC FILE SYSTEM  Group 1/RECIPROC BLUE group-Root canal preparation will be done with the RECIPROC BLUE system (VDW) with strict adherence to the manufacturer’s instructions. After coronal preflaring with a R25 instrument with 5.25% sodium hypochlorite (Prima Dental,India) as the irrigant, working length will be determined and a glide path will be created. The R25 files (25/.08) will be used to complete the root canal shaping if a size 15 file fit passively into the canal. In group l, after 3 pecking movements, the file will be removed from the canal, and the debris accumulated on the file will be removed by a gauze strip immersed in alcohol. Three in and out motions will be applied with stroke lengths not exceeding 3 mm in the cervical, middle and apical thirds until attaining the established working length. 
Intervention  GROUP II-ROTARY FILE SYSTEM  Group 11/HYFLEX EDM group- Glidepath will be prepared using 10/05 HDEM GPF file.Gentle apical strokes and pecking movements in accordance with the recommendations of the manufacturer (continuous rotation at 500 rpm speed and 2.5-Ncm torque value) will be used to prepare the canals with file 25/0.08. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  •Patients within the age group of 20–40 years
•Patients with no history of taking analgesics or antibiotics within one week
•Tooth with chronic apical periodontitis with periapical lesion less than 3mm
•Ability to apply a rubber dam
•Single rooted tooth with single canal with no curvature(radiographically assessed).
 
 
ExclusionCriteria 
Details  •Teeth without good apical constriction, such as wide or open apex
•Retreatment cases
• Patients who were on medication for chronic pain
•Teeth with difficult root canal anatomy (resorption, radiographic evidence of calcification, or open apices)
•Two or more adjacent teeth requiring root canal therapy
•Presence of sinus tracts
•Medically compromised patients
•Tooth with periodontal pathosis and weakened periodontium
•Tooth with long roots and wide canals (which cannot be instrumented with 25 size file with 25 mm length)
•Infectious diseases
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
POST OPERATIVE PAIN MEASURED USING VISUAL ANALOGUE SCALE AFTER
BIOMECHANICAL PREPARATION STEP OF ROOT CANAL TREATMENT 		 POST OPERATIVE PAIN MEASURED USING VISUAL ANALOGUE SCALE AT 24 hrs,48hrs AND 72 hrs AFTER BIOMECHANICAL PREPARATION STEP OF ROOT CANAL TREATMENT 
 
Secondary Outcome  
Outcome  TimePoints 
INTENSITY OF PAIN IS MEASURED AS MILD,MODERATE OR SEVERE USING VISUAL ANALOGUE SCALE   INTENSITY OF PAIN IS MEASURED AT 24HRS,48 HRS AND 72 HRS 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/06/2021 
Date of Study Completion (India) 02/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This study is a Randomized Clinical Trial.The aim of this study was to evaluate and compare the effectiveness of rotary and reciprocating single file systems on postoperative pain after biomechanical preparation in patients with chronic apical periodontitis.The study was going to be conducted over a period of 18 months.The study population consisted of patients within the age group of 20 to 40 years, reporting to the Department of Conservative Dentistry and Endodontics, Government Dental College, Kozhikode with a diagnosis of chronic apical periodontitis in single rooted teeth.The total sample size was 94 (47 in each group).Post operative pain after biomechanical preparation  using two file systems will be evaluated at 24 hrs.48 hrs and 72 hrs using Visual Analogue Scale.The study result showed no difference in mean pain value between the two groups of files used.Both the file systems showed low pain intensity in both the groups and there was significant reduction in post operative pain from 24 hrs to 72 hrs post treatment.The frequency of analgesic intake was also found to be similar.Hence the study concludes that both file systems can be used efficiently with regard to post operative pain.  
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