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CTRI Number  CTRI/2023/07/054831 [Registered on: 06/07/2023] Trial Registered Prospectively
Last Modified On: 03/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study on post operative pain after single sitting root canal treatment. 
Scientific Title of Study   Comparative Evaluation of Post-operative Pain Following Single Visit Endodontics by using Two NiTi File Systems based on Different kinematics: A Randomized Clinical Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rutuja Rajput 
Designation  Post Graduate student 
Affiliation  MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE 
Address  SECOND FLOOR ,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Raigarh MAHARASHTRA

Raigarh
MAHARASHTRA
410210
India 
Phone  8169752300  
Fax    
Email  ruturajput30@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rutuja Rajput 
Designation  Post Graduate student 
Affiliation  MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE 
Address  SECOND FLOOR ,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Raigarh MAHARASHTRA

Raigarh
MAHARASHTRA
410210
India 
Phone  8169752300  
Fax    
Email  ruturajput30@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anuradha Patil 
Designation  Professor 
Affiliation  MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE 
Address  SECOND FLOOR ,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Raigarh MAHARASHTRA

Raigarh
MAHARASHTRA
410209
India 
Phone  9819875730  
Fax    
Email  anuradhapatil32@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, MGM Dental College and Hospital 
 
Primary Sponsor  
Name  MGM Dental College and Hospital 
Address  MGM Dental College and Hospital Junction of NH-4 and Sion Panvel Expressway, Sector-1, Kamothe, Navi Mumbai  
Type of Sponsor  Private hospital/clinic 
 
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 Rutuja Rajput  MGM Dental College and Hospital  Second floor, Room NO 9, Department of Conservative Dentistry and Endodontics,Post Graduate section, MGM Dental College and Hospital Raigarh MAHARASHTRA
Raigarh
MAHARASHTRA 
8169752300

ruturajput30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MGM Dental College and Hospital  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  TruNatomy Rotary NiTi file system  root canals will be shaped using TruNatomy Rotary NiTi file system  
Comparator Agent  WaveOne Gold reciprocating NiTi file system  root canal will be shaped using WaveOne Gold reciprocating NiTi file system  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.All vital single-rooted teeth with irreversible pulpitis, whether associated with or without apical periodontitis, and mild to moderate pain (VAS value 5-74mm) indicated root canal treatment.2.Maxillary and mandibular premolars with single root and single canal.3.Patients with single rooted permanent teeth with periapical
radiolucency less than 1.5 mm as determined by an intraoral periapical (IOPA) radiograph.
4.Teeth with fully developed apex and straight canals with minimal curvature (0 to 10 degrees)
5.Teeth with healthy periodontium with periodontal probing depth
3  
 
ExclusionCriteria 
Details  1.Pregnant women and lactating mothers.
2. Patients with acute dentoalveolar abscess or cellulitis.
3. Patients presenting with severe pain (75-100mm).
4. Patients who have taken antibiotics and analgesics and corticosteroid in the past month. 5.Patients with known immunocompromised conditions (e.g., AIDS)
6.Patients who are known diabetic.
7.Patients with non-vital teeth and intraoral and extraoral sinus tract
8.Patients with radiographic evidence of radiolucency of more than 1.5 mm
9. Patients who are having teeth with Single roots having multiple canals, bifurcation and trifurcation of canals, canal aberration, calcified canals. open apex, root resorption. presence of root caries and multirooted teeth
10. Teeth with aggressive periodontitis and grade III mobility, periodontal probing depth >3mm.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
compare the of post-operative pain in
single-visit endodontics where canal instrumentation will be done using
two different rotary instrument systems. For each patient, the
preoperative and post-operative pain levels will be recorded by using a
visual analogue scale (VAS) 
The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/09/2023 
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="1"
Months="0"
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  

Title: Comparative evaluation of post-operative pain following single visit endodontics using of two NiTi file systems based on different kinematics: A Randomized clinical study.

Dental pain is most commonly induced by caries disease which is caused by specific types of bacteria. The caries disease elicits subsequent inflammation which might necessitate endodontic treatment the primary goal of endodontic treatment is to eliminate disease and manage the symptoms of the patientPostoperative pain is an unpleasant sensory experience in patients undergoing endodontic treatment and has been reported in 25-40% of all endodontic patients. This pain is caused by the release of inflammatory mediators in the periradicular region due to increased vascular permeability and consequent oedema, which lead to the compression of nerve fibers in that region.

 Extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment. Clinically, a

 relationship exists between the presence of inflammatory mediators and the extrusion of debris, which depends on the preparation of the root

 canal system.

Several clinical trials have compared the effect of reciprocating and rotation kinematics on postoperative pain and reported conflicting results, which might be attributed to the use of different instrumentation systems with different mechanical properties and designs. Therefore, further clinical data are necessary to elucidate the effect of endodontic instruments on postoperative pain.

This study is a prospective, single-centre, double blind randomized clinical study with a concurrent parallel study design. Consecutive, Consenting sampling. Comparison will be done on of postoperative pain following single visit endodontics after the use of two NiTi file systems based on different kinematics: 80 patients will be selected on the basis of inclusion and exclusion criteria. Which further divide into 40 participants each. The patient will be allotted to one of the instrumentation techniques by random allocation using Graph pad by domatics software. Concealment allocation will be carried out by using sequentially numbered sealed opaque envelopes by a neutral observer. After randomization, allotted group will be written on a paper and kept in an opaque sealed envelope

Group 1: Root canals will be prepared by TruNatomy rotary system.

Group 2: Root canals will be prepared by WaveOne Gold reciprocating system. Cleaning and shaping of the canal will ne by done in which.

The patient will be given post-operative instructions and will be recalled at the following intervals: 6 hours, 24 hours and 7 days, and evaluated

for pain scale. Pain assessment will be done with the help of visual analogue scale (VAS). Participants will be asked to place a single mark on line to indicate current level of the pain. Using a ruler, distance was measured in mm from “no pain” anchor to mark on visual analogue scale line.

Although all instrumentation techniques produce apical extrusion of debris, the difference lies in the ability of some techniques to extrude less debris than others.

The rationale of this study is to evaluate the of post-operative pain in patients with chronic irreversible pulpitis following single-visit endodontics using two different nickel-titanium file systems based on different kinematics. This study would determine whether the use of the instruments would influence the occurrence of post-operative pain

 
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