FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/04/032667 [Registered on: 08/04/2021] Trial Registered Prospectively
Last Modified On: 07/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pain after root canal treatment 
Scientific Title of Study   Postoperative pain associated with root canal treatment when using the XP-Endo Finisher to agitate the irrigant - a randomized controlled 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  Vasudev Ballal 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences 
Address  Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  09880626167  
Fax    
Email  drballal@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Vasudev Ballal 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences 
Address  Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  09880626167  
Fax    
Email  drballal@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Vasudev Ballal 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences 
Address  Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  09880626167  
Fax    
Email  drballal@yahoo.com  
 
Source of Monetary or Material Support  
FKG Swiss Endo Switzerland 
 
Primary Sponsor  
Name  Manipal College of Dental Sciences 
Address  Manipal Academy of Higher Education 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Cardiff University  Cardiff, UK 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vasudev Ballal  Manipal College of Dental Sciences  Department of Conservative Dentistry Endodontics Manipal College of Dental Sciences MAHE
Udupi
KARNATAKA 
09880626167

drballal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba 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 
Comparator Agent  Needle irrigation  Cleaning of the root canal is done with needle irrigation 
Intervention  XP endo finisher  XP endo finisher file is used to clean the root canals 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a) Healthy patients above 18 years of age;
b) Molar teeth with symptomatic irreversible pulpitis or necrotic pulps;
c) Patients with preoperative pain score that does not exceed 3 on a NRS-11 scale.

 
 
ExclusionCriteria 
Details  a) Patients who are not willing, or able to give informed consent;
b) Patients who had taken analgesic or anti-inflammatory drugs within the last 12 hours;
c) Non-restorable teeth;
d) Teeth with calcified canals as seen radiographically;
e) Patients allergic to non-steroidal anti-inflammatory (NSAIDs) drugs;
f) Teeth with open/immature apex, and root resorption as seen radiographically;
g) Teeth tender to percussion;
h) Pregnant or lactating patients;
i) Periodontally compromised teeth (loss of attachment).
 
 
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 
Post treatment pain  6 h, 12 h, 24 h, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day after shaping  
 
Secondary Outcome  
Outcome  TimePoints 
Analgesic intake after shaping  6 h, 12 h, 24 h, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day after shaping  
 
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   Phase 4 
Date of First Enrollment (India)   15/04/2021 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

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

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (drballal@yahoo.com).

  6. For how long will this data be available start date provided 15-04-2021 and end date provided 30-04-2023?
    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  

Although root canal treatment alleviates pain, postoperative pain after root canal treatment is a common problem (Gondim et al. 2010) and has been reported to range from 3% to 58% (Albashaireh et al.1998, Sathorn et al. 2008). The aetiology of postoperative pain following root canal treatment is multifactorial. It may be due to inadequate cleaning and shaping of the canal system, presence of periapical pathosis, apical extrusion of debris, missed canals, over-instrumentation, and/or extrusion of irrigating solutions and intracanal medicaments (Seltzer 1986, Harrison et al. 1983, Siqueira et al. 2002). To prevent periapical tissue damage and reduce postoperative pain, a safe irrigation delivery system is desirable. Conventional irrigation with a syringe and needle remains a widely accepted technique; however, it has been shown to be incapable of cleaning areas that are difficult to access such as the apical third of the canal and isthmus regions (Lee et al. 2004). Also, when needle irrigation is used an apical stagnation zone is created beyond the tip of the needle where, irrigant exchange does not take place (Glulabivala et al. 2010) and as a result its effectiveness is reduced. As a consequence, a number of irrigation activation techniques, such as manual agitation, sonic or ultrasonic activation and negative pressure systems, have been proposed to improve the movement of irrigants (agitation) within the canal and thus their efficacy within the root canal system (Haapasalo et al. 2010, Glulabivala et al. 2010, Mazo et al. 2012).It has been reported that irrigation devices have an effect on apical extrusion of debris and irrigants (Mitchell et al. 2011, Boutsioukis et al. 2014) and have the potential to increase postoperative discomfort. This study evaluated postoperative pain after activation of the final irrigant solution using XP Endo Finisher compared to traditional needle irrigation in teeth with symptomatic irreversible pulpitis and in teeth with necrotic pulps and apical periodontitis.





 
Close