| CTRI Number |
CTRI/2026/01/101278 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study on the Effect of Cold Saline Irrigation on Pain After Root Canal Treatment |
|
Scientific Title of Study
|
Effect of Cryotherapy on Postoperative Pain Following Root Canal Treatment with
Continuous Chelation: A Randomized Controlled Clinical Trial |
| 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 Deepika |
| Designation |
Senior Resident (Dentistry) |
| Affiliation |
AIIMS,Patna |
| Address |
Department of Dentistry,All India Institute of Medical Sciences,Patna,Phulwarisharif
Patna
BIHAR
801507
India |
| Phone |
7762831778 |
| Fax |
|
| Email |
9deepe12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rudra Deo Kumar |
| Designation |
Assistant Professor (Dentistry) |
| Affiliation |
AIIMS,Patna |
| Address |
Department of Dentistry,All India Institute of Medical Sciences,Patna,Phulwarisharif.
Patna
BIHAR
801507
India |
| Phone |
9990542866 |
| Fax |
|
| Email |
rudraadhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rudra Deo Kumar |
| Designation |
Assistant Professor (Dentistry) |
| Affiliation |
AIIMS,Patna |
| Address |
Department of Dentistry,All India Institute of Medical Sciences,Patna,Phulwarisharif.
Patna
BIHAR
801507
India |
| Phone |
9990542866 |
| Fax |
|
| Email |
rudraadhir@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences,Patna,Bihar. |
| Address |
All India Institute of Medical Sciences,Patna,Bihar. |
| Type of Sponsor |
Government medical 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 |
| Dr Deepika |
AIIMS, Patna |
Department of Dentistry, Room no-35.
Patna
BIHAR |
7762831778
9deepe12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuous Chelation + Room-Temperature Irrigation |
Root canal treatment performed using a continuous chelation irrigation protocol with 3% sodium hypochlorite combined with 9% etidronic acid(1-hydroxyethylidene-1,1-bisphosphonate; HEDP) during instrumentation. Final irrigation is performed using 10 mL of sterile normal saline at room temperature, delivered slowly over 5 minutes, without intracanal cryotherapy. |
| Intervention |
Cryotherapy Group: Continuous Chelation + Cold Irrigation |
Root canal treatment performed using a continuous chelation irrigation protocol with 3% sodium hypochlorite combined with 9% etidronic acid (1-hydroxyethylidene-1,1-bisphosphonate; HEDP)during instrumentation. Intracanal cryotherapy is applied as the final irrigation using 10 mL of sterile normal saline cooled to 2.5 °C, delivered slowly over 5 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with maxillary or mandibular molars diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis, having a baseline Visual Analog Scale pain score between eight and ten, and willing to provide written informed consent and comply with the follow up schedule. |
|
| ExclusionCriteria |
| Details |
Patients presenting with internal or external resorption, vertical root fracture, retreatment cases, open apices, advanced periodontal disease, immunocompromised status, or a history of chronic pain medication, as well as pregnant or lactating women, will be excluded. |
|
|
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 intensity using visual analog scale
(VAS) at 6 hours, 12hours, 24 hours, 48 hours and 7 days after the first session of root
canal treatment. |
Postoperative pain intensity using visual analog scale
(VAS) at 6 hours, 12hours, 24 hours, 48 hours and 7 days after the first session of root
canal treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare analgesic intake as in control & intervention groups. |
6 hours, 12hours, 24 hours, 48 hours & 7 days after the first session of root
canal treatment. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 2 |
|
Date of First Enrollment (India)
|
23/01/2026 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Postoperative pain following root canal treatment is a common clinical problem. Continuous chelation using sodium hypochlorite in combination with etidronic acid (HEDP) provides effective canal disinfection while simultaneously managing the smear layer throughout instrumentation. Sodium hypochlorite (NaOCl) remains the primary endodontic irrigant because of its strong antibacterial, antibiofilm, and tissue-dissolving properties; however, its inability to remove the inorganic smear layer and the limitations of conventional chelators such as ethylenediaminetetraacetic acid.( EDTA) have led to the adoption of continuous chelation protocols. Etidronic acid (1-hydroxyethylidene-1,1-bisphosphonate; HEDP) is a mild, biocompatible chelating agent that can be safely combined with NaOCl without reducing its antimicrobial efficacy. In this study, continuous chelation will be performed using sodium hypochlorite 3% mixed with etidronic acid 9% (Twin Kleen®, Maarc Dental Innovations, Endo Division, India).
Intracanal cryotherapy using cold saline irrigation has been shown to reduce postoperative pain by decreasing periapical inflammation and nerve conduction. However, the combined effect of intracanal cryotherapy following continuous chelation has not been adequately evaluated.
This prospective, double-blind, randomized controlled trial will include 84 participants allocated into two groups (42 per group). All participants will undergo standardized root canal treatment. The control group will receive continuous chelation followed by final irrigation with room-temperature saline, while the intervention group will receive the same protocol followed by final irrigation with cold saline at 2.5 °C. Calcium hydroxide will be placed as an intracanal medicament, and obturation will be completed at a second visit after 7 days.
The primary outcome is postoperative pain intensity assessed using a Visual Analog Scale at 6, 12, 24, and 48 hours, and 7 days after the first treatment session. Secondary outcomes include postoperative analgesic consumption.
|