| CTRI Number |
CTRI/2020/10/028447 [Registered on: 16/10/2020] Trial Registered Prospectively |
| Last Modified On: |
23/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different irrigating systems on post operative pain after root canal treatment |
|
Scientific Title of Study
|
Comparative evaluation of post-endodontic pain using Ultra – X and Manual dynamic
irrigation in single rooted teeth after single visit endodontics – Randomised 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 |
Anu Cherian |
| Designation |
Post Graduate Student |
| Affiliation |
K M Shah Dental College |
| Address |
D201, Bakeri Swara, Makarpura
Sumandeep Vidyapeeth
Piparia
Vadodara
GUJARAT
390013
India |
| Phone |
07016108275 |
| Fax |
|
| Email |
anuthenamkodath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dexter Brave |
| Designation |
Reader and PG Guide |
| Affiliation |
K M Shah Dental College |
| Address |
Department of Conservative dentistry and Endodontics
KM Shah Dental College
Sumandeep Vidyapeeth
Vadodara
Sumandeep Vidyapeeth
Piparia
Vadodara
GUJARAT
391760
India |
| Phone |
09833048365 |
| Fax |
|
| Email |
smilep91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anu Cherian |
| Designation |
Post Graduate Student |
| Affiliation |
K M Shah Dental College |
| Address |
D201, Bakeri Swara, Makarpura
Sumandeep Vidyapeeth
Piparia
Vadodara
GUJARAT
390013
India |
| Phone |
07016108275 |
| Fax |
|
| Email |
anuthenamkodath@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M Shah Dental College,Department of conservative dentistry and endodontics, Sumandeep Vidyapeeth, Vadodara |
|
|
Primary Sponsor
|
| Name |
K M Shah Dental College |
| Address |
Room no: 8,
Department of conservative dentistry and endodontics, K M Shah Dental College, Sumandeep Vidyapeeth, Vadoadara |
| Type of Sponsor |
Other [Private Dental College] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anu Cherian |
K M Shah Dental College |
Room no 8
Department of conservative dentistry and endodontics
Vadodara
GUJARAT |
07016108275
anuthenamkodath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SVIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
irreversible pulpitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manual dynamic agitation |
Manual dynamic agitation with master size gutta percha cones |
| Intervention |
Ultra X |
Passive ultrasonic irrigation using Ultra x with tip of size 20 and 25 (2%) is used with irrigant |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
single rooted maxillary and mandibular teeth with symptomatic irreversible pulpitis |
|
| ExclusionCriteria |
| Details |
Patients with poor oral hygiene, severe bruxism, chronic periodontitis, immature apices, root resorption and medically compromised |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post-endodontic pain with Ultra – X with that of Manual dynamic agitation as the irrigation method in single rooted teeth after Single visit endodontics using Verbal Rating Scale |
6hrs, 24 hrs, 48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the post-endodontic pain with Manual dynamic agitation with sodium hypochlorite as the irrigation method in single rooted teeth after Single visit endodontics using Verbal Rating Scale at 6 hours, 24 hours and 48 hours.
2. To evaluate the post-endodontic pain with Ultra – X with sodium hypochlorite as irrigation method in single rooted teeth after Single visit endodontics using Verbal Rating Scale at 6 hours, 24 hours and 48 hours
|
6, 24 and 48 hours |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2020 |
| Date of Study Completion (India) |
23/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/12/2020 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparative evaluation of post-endodontic pain using Ultra – X and Manual dynamic irrigation in single rooted teeth after single visit endodontics – Randomized Clinical StudyAfter institutional ethical approval and informed consent from subjects a total of 72 teeth were included in this study. Subjects will be randomly assigned in two groups (n=36) : Group A- Ultra X, Group B- Manual dynamic agitation. In both groups similar protocols will be used for instrumentation, irrigation and obturation. Final irrigation will be done using different irrigation systems. Evaluation of postoperative pain will be done in both groups after 6-hrs, 24-hrs and 48-hrs using a verbal rating scale (VRS).
|