| CTRI Number |
CTRI/2021/02/031174 [Registered on: 10/02/2021] Trial Registered Prospectively |
| Last Modified On: |
12/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the postoperative pain following the use of different irrigation activation systems |
|
Scientific Title of Study
|
A comparative evaluation of postoperative pain following the use of different irrigation activation systems in posterior teeth with symptomatic irreversible pulpitis with/without apical periodontitis : A prospective double blind randomized 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 |
Shikha Jain |
| Designation |
Student |
| Affiliation |
College of dental science and hospital,Rau. Indore |
| Address |
Room no.6, Department of conservative dentistry and endodontics, College of dental science and hospital ,Rau, Indore (M.P.)
Indore
MADHYA PRADESH
452018
India |
| Phone |
9806506684 |
| Fax |
|
| Email |
shikhajain197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suparna Ganguly Saha |
| Designation |
Professor and Head of the Depatment |
| Affiliation |
College of dental science and hospital,Rau. Indore |
| Address |
Room no.6, Department of conservative dentistry and endodontics, College of dental science and hospital ,Rau, Indore (M.P.)
Indore
MADHYA PRADESH
452018
India |
| Phone |
9303211635 |
| Fax |
|
| Email |
drsuparna26@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shikha Jain |
| Designation |
Student |
| Affiliation |
College of dental science and hospital,Rau. Indore |
| Address |
Room no.6, Department of conservative dentistry and endodontics, College of dental science and hospital ,Rau, Indore (M.P.)
Indore
MADHYA PRADESH
452018
India |
| Phone |
9806506684 |
| Fax |
|
| Email |
shikhajain197@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of dental science and hospital,
F-12,Jhoomer Ghat, Near Hotel Mashal, A.b.Road, Rau, Indore, (M.P.) 453331 India
Indore
MADHYA PRADESH |
|
|
Primary Sponsor
|
| Name |
Shikha Jain |
| Address |
4,kalpaka apartment
406, saket nagar
Indore (M.P.) |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Shikha Jain |
College of dental science and hospital. Rau |
Room no.6, Department of conservative dentistry and endodontics
Indore
MADHYA PRADESH |
9806506684
shikhajain197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Irreversible pulpitis with/without apical periodontitis in maxillary and mandibular posterior teeth |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Root canal irrigation activation systems
During root canal treatment root canal irrigation activation systems allow the access of irrigants into the intricacies of the root canal . Compared to traditional methods, activating endodontic irrigant allows more thorough disinfection of the root canal system. |
Manual Dynamic Agitation,
Sonic Activation,
Ultrasonic Activation,
XP Endo Finisher |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 15 to 60 years.
2. Permanent posterior teeth.
3. Teeth with irreversible pulpitis with/without
apical periodontitis.
4. Teeth with mature apices.
5. Teeth with non-calcified canals.
|
|
| ExclusionCriteria |
| Details |
1. Non-vital teeth with/without periapical
pathology.
2. Teeth with
- root resorption
- immature apices
- mobility
- indicated for intentional root canal
treatment
- poor periodontal health
- complex anatomy ( Curvature more than and equal to 30°, Radix
Entomolaris, Radix Paramolaris)
- root caries
3. Cases of swelling .
4. Retreatment cases.
5. Grossly decayed teeth.
6. Pregnant patients.
7. Medically compromised patients.
8. Patients having history of analgesics or
nonsteroidal or steroidal anti inflammatory
drugs intake within past 12 hours.
|
|
|
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 |
| Postoperative pain |
24 hours, 48 hours, 72 hours and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analgesic intake |
24 hours, 48 hours, 72 hours and 7 days |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
25/02/2021 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a double blind , parallel group , randomized controlled trial comparing the postoperative pain (after 24 hours,48 hours,72 hours and 7 days) following the use of different irrigation activation systems i.e. Manual Dynamic Agitation (MDA) , Endoactivator, Passive Ultrasonic Irrigation, (PUI) and XP endo finisher file in posterior teeth with irreversible pulpitis with/without apical periodontitis that will be counducted in a center in India . The postoperative pain will be measured by Visual Analogue Scale(VAS) . |