| CTRI Number |
CTRI/2025/07/090142 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing post-treatment pain in patients receiving root canal therapy in single rooted teeth with three different irrigation methods. |
|
Scientific Title of Study
|
Comparative assessment of postoperative pain following three different irrigation activation techniques in endodontic therapy of single-rooted teeth: A randomized clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mokshada Ravindra Kasod |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Institute of Dental Sciences and Research,Nashik |
| Address |
SMBT Institute of Dental Sciences and Research ,Nandi Hills, Dhamangaon,Igatpuri,
Dist, Nashik,Department of Conservative Dentistry and Endodontics Room number 201
Nashik
MAHARASHTRA
422403
India |
| Phone |
09423829931 |
| Fax |
|
| Email |
mokshadakasod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aarti Bohora |
| Designation |
Professor and PG guide |
| Affiliation |
SMBT Institute of Dental Sciences and Research,Nashik |
| Address |
SMBT Institute of Dental Sciences and Research ,Nandi Hills, Dhamangaon,Igatpuri,
Dist, Nashik. Department of Conservative Dentistry and Endodontics Room number 201
Nashik
MAHARASHTRA
422403
India |
| Phone |
7020054267 |
| Fax |
|
| Email |
draab.endo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mokshada Ravindra Kasod |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Institute of Dental Sciences and Research,Nashik |
| Address |
SMBT Institute of Dental Sciences and Research ,Nandi Hills, Dhamangaon,Igatpuri,
Dist, Nashik,Department of Conservative Dentistry and Endodontics Room number 201
Nashik
MAHARASHTRA
422403
India |
| Phone |
09423829931 |
| Fax |
|
| Email |
mokshadakasod@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Institute of Dental Sciences and Research,Nashik,Department of Conservative Dentistry and
Endodontics. Room Number 201. |
|
|
Primary Sponsor
|
| Name |
Dr. Mokshada Ravindra Kasod |
| Address |
SMBT Institute of Dental Sciences and Research,Nashik,Department of Conservative Dentistry and
Endodontics. Room Number 201. |
| 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 |
| Dr Mokshada Ravindra Kasod |
SMBT Institute of Dental Sciences and Research,Nashik |
SMBT Institute of Dental Sciences
and Research ,Nandi Hills,
Dhamangaon,Igatpuri, Dist,
Nashik. Department of
Conservative Dentistry and
Endodontics.
Room number 201.
Nashik
MAHARASHTRA |
09423829931
mokshadakasod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT IDSR |
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 |
Conventional
Syringe
Irrigation
(CSI) |
The most common technique in endodontics for irrigation is
conventional needle irrigation. The irrigant replenishment and exchange
in the apical part, lateral canal, and isthmus of the canal are
inadequate. Additionally, positive pressure may cause postoperative
discomfort by forcing the irrigant into periradicular tissues. Thus, the
conventional needle lags in providing significant quantities of irrigation
fluid to the whole root canal and untouchable portions in a safe and
effective manner. The final irrigation in this group will be done with 5.25% NaOCl using a 30G, 27 mm side-vent needle (Irriflex, PD Swiss), 1 mm from the working length for 3 min (flow rate, 2 mL/min). |
| Intervention |
Negative
Pressure
Irrigation
(NPI) |
Utilizes a suction mechanism to draw irrigants down the root canal
system, ensuring deep penetration while minimizing the risk of irrigant
extrusion beyond the apex. The apical negative pressure irrigation
technique was shown to be the most effective in delivering the irrigant
up to the working length.Irrigant will be delivered by a syringe and needle inside the pulp chamber and a fine suction tip(Endoaspirator Pro-Cerkamed) will be placed near the working length which will create the necessary negative pressure that drives the irrigant into the canal. |
| Intervention |
Sonic Activation (SA) |
Employs sonic energy to agitate the irrigant using polymer tips,
increasing fluid movement and penetration. It has been shown that the
EndoActivator system produces effective irrigation in the lateral canals,
and extrusion of the irrigant is less than that of conventional methods
while less aggressive than ultrasonic activation. There are different
studies in the literature showing that the use of sonic activation (SA) of
irrigation reduces postoperative pain after root canal treatment in
permanent teeth.The irrigant will be agitated with Endoactivator(Dentsply Sirona,Maillefer).The irrigants will be agitated using polymer tips(Dentsply Sirona, Maillefer Endoactivtor activator Tips) for 30 s before changing the solution |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with symptomatic or asymptomatic irreversible pulpitis , apical
periodontitis requiring root canal therapy in single rooted teeth. |
|
| ExclusionCriteria |
| Details |
-Multi-rooted Maxillary and Mandibular teeth
-Patients with systemic conditions affecting pain perception, retreatment cases.
-Patients with apical abscess.
-Patient requiring antibiotic medications.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will help in selecting the most effective irrigation activation method to minimize postoperative pain, enhancing patient comfort and satisfaction. |
6, 12, 24, and 48 hours
postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need of Analgesic intake after root canal therapy. |
6, 12, 24, and 48 hours
postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Total 60
single rooted teeth indicated for root canal treatment will be included in the
study.
Informed
consent will be obtained from patients.
Preoperative
radiographs of selected teeth will be taken to ensure the inclusion criteria.
Patients
will be asked to quantify their pain on a Visual Analog Pain Intensity Scale,
prior giving suitable anesthesia.
Rubber
dam application will be done
Access opening with endodontic access burs and minimal instrumentation with a
15-size K-file will be done
Biomechanical Preparation of
canals will be performed up to a standard size (Step back technique, three
sizes beyond the size of the first instrument that binds), with 5.25% sodium
hypochlorite irrigation.
Randomization
of the participants will be done by chit system before selecting final
irrigation protocol.
Single blinding will be followed.
On the
basis of the final irrigation protocol, the patients will be allotted one of
the three groups:
Groups:
1.
Conventional syringe
irrigation (CSI)
2.
Sonic activation
(SA)
3.
Negative pressure
irrigation (NPI)
The final
irrigation in Group 1 will be done with 5.25% NaOCl using a 30G, 27 mm side-vent needle (Irriflex,
PD Swiss), 1 mm from the working length for 3 min (flow rate, 2 mL/min).
In
Group 2: The irrigant will be introduced as in Group A and agitated with
Endoactivator(Dentsply Sirona,Maillefer).The irrigation protocol will be
similar to that used in Group A, but the irrigants were agitated using polymer
tips(Dentsply Sirona, Maillefer Endoactivtor activator Tips) for 30 s before
changing the solution
In
Group 3: : Irrigant
will be delivered by a syringe and needle inside the pulp chamber and a fine
suction tip(Endoaspirator Pro-Cerkamed) will be placed near the working length which
will create the necessary negative pressure that drives the irrigant into the
canal.
Patient
will be given a temporary dressing(Cavit-G) and will be recalled for
obturation.
Following the intervention, patients will be given
postoperative forms to record pain levels. They will receive instructions to
record Visual Analog Scale pain scores at 6, 12, 24, and 48 h postoperatively,
with messages sent as reminders. They will be asked to categorise their pain
experience into five categories: 0 (no pain), 1–3 (mild pain), 3–5 (moderate
pain), 5–9 (severe pain), and 10(worst possible pain).
If pain was unmanageable, patients will be informed to
contact the principal investigator. Ibuprofen 400 mg (Abbott, India) will be
prescribed as a rescue drug. Data recorded after the time of taking rescue drug
will be excluded from the study.
|