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CTRI Number  CTRI/2021/01/030472 [Registered on: 14/01/2021] Trial Registered Prospectively
Last Modified On: 03/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the pain after root canal treatment in decayed lower back tooth using two different instrumentation techniques INSTRUMENTATION TECHNIQUES 
Scientific Title of Study   “Evaluation of postoperative endodontic pain of rotary and reciprocation instrumentation techniques in necrotic, mandibular molars : A randomized, double blind 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 Catherine Eugine 
Designation  Junior Resident 
Affiliation  Govt.Dental College,Kottayam 
Address  Govt.Dental College,Gandhinagar P.O.Kottayam

Kottayam
KERALA
686008
India 
Phone  8289878334  
Fax    
Email  catherineeugine2106@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SHOBA K 
Designation  Head of the department, Department of Conservative Dentistry and Endodontics 
Affiliation  Govt.Dental College,Kottayam 
Address  Govt.Dental College, Gandhinagar P.O. Kottayam

Kottayam
KERALA
686008
India 
Phone  9745205407  
Fax    
Email  drshobak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DRSHOBA K 
Designation  Head of the department, Department of Conservative Dentistry and Endodontics 
Affiliation  Govt.Dental College,Kottayam 
Address  Govt.Dental College, Gandhinagar P.O. Kottayam

Kottayam
KERALA
686008
India 
Phone  9745205407  
Fax    
Email  drshobak@gmail.com  
 
Source of Monetary or Material Support  
Govt.Dental College,Gandhinagar P.O. ,Kottayam,Kerala 
 
Primary Sponsor  
Name  DRCATHERINE EUGINE 
Address  GOVT.DENTAL COLLEGE,GANDHINAGAR P.O. KOTTAYAM 
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 
DRCATHERINE EUGINE  GOVT.DENTAL COLLEGE,KOTTAYAM  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
Kottayam
KERALA 
8289878334

catherineeugine2106@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,GOVT.DENTAL COLLEGE ,KOTTAYAM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  ROOTCANAL TREATMENT USING RECIPROCATING INSTRUMENTATION TECHNIQUE  ROOTCANAL TREATMENT IS DONE USING THE RECIPROCATING FILE,WAVE ONE 
Intervention  ROOTCANAL TREATMENT USING ROTARY INSTRUMENTATION TECHNIQUE  ROOTCANAL TREATMENT IS DONE USING THE ROTARY FILE,XP ENDOSHAPER 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  • Patients within age group of 25-45 years reporting at O.P of department of Conservative dentistry and Endodontics, Govt. dental college Kottayam.
• Patients with necrotic first or second mandibular molar with periapical lesions less than or equal to 2mm.
• Patients who sign informed consent forms outlining the purpose of study.
 
 
ExclusionCriteria 
Details  • Patients with history of medicine intake including corticosteroids, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) in the past 12 hrs.
• Patients suffering from any systemic disease.
Teeth with periapical lesions greater than 2mm,complicated anatomy (curves greater than 25 degrees), calcifications, internal and external resorption, open apices, periodontal disease, swelling and abscess, sensitivity to percussion.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale Scorings-No pain, mild pain, moderate pain, and severe pain will be indicated by 0-mm, 1–54-mm,55–113-mm, and 114–170-mm divisions,   6-, 12-, 18-, 24-, 48-, and 72-h postoperative intervals 
 
Secondary Outcome  
Outcome  TimePoints 
EVALUATION OF POSTOPERATIVE ENDODONTIC PAIN OF ROTARY AND RECIPROCATION INSTRUMENTATION TECHNIQUES   6-, 12-, 18-, 24-, 48-, and 72-h postoperative intervals 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   26/02/2021 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Post-endodontic pain is an annoying experience for the patient, undermining the patient-clinician relationship . Despite major improvements in armamentarium and pharmacologic interventions, pain after endodontic treatment remains to be a major problem.

                      Dentin and pulp tissue debris, microorganisms and irrigating solutions may extrude into periradicular tissues during the preparation of root canals , thus causing complications such as postoperative pain and flare ups. All instruments and techniques that are used for root canal preparation may cause extrusion of different amounts of root canal contents outside the apical foramen . It has been reported that the amount of extruded contents may be influenced by the design and kinematics of endodontic files .

                         The concept of single-file canal preparation was introduced in endodontics  with the launch of  Wave One instrumentation system. These instruments are fabricated with a nickel-titanium alloy called M-Wire using an innovative thermal treatment .The reciprocating motion involves an initial rotation of the instrument in a counter clockwise direction, during which the instrument penetrates and cuts the dentin, and then a rotation in the opposite direction, during which the instrument is released.Several studies have shown that a single file reciprocating system produced more debris extrusion than single file rotary systems.

                             XP-endo Shaper (XP) , a novel snake-shaped NiTi rotary system is recently introduced. According to the manufacturer’s instructions , the file has a taper of 0.01 in its martensitic phase when it is cooled and the taper changes to 0.04 at body temperature (370C) by the molecular memory in austenitic phase. The metallurgic alloy provides high flexibility to the file and XP is expected to produce minimal stress on the dentin walls; resulting in minimal extrusion of debris.

                          Periapical extrusion of debris is the main cause for postoperative pain after root canal treatment. The purpose of this investigation is to evaluate the post operative pain after root canal treatment  in patients with necrotic mandibular molar teeth  using two different instrumentation techniques: single file rotary and single file reciprocation .

 
  
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