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
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- 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).
- 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.
- 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.
|