| CTRI Number |
CTRI/2025/11/097836 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| 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 Clinical Study Comparing Cold Irrigation and Silver–Chitosan Irrigation to Standard Techniques to Reduce Pain After Root Canal Treatment. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF CRYOTHERAPY AND
SILVER NP–CHITOSAN NP IRRIGATION REGIMEN TO STANDARD IRRIGATION REGIMEN IN POST-OPERATIVE PAIN REDUCTION IN THE INDIVIDUALS NEEDING ENDODONTIC TREATMENT : A RANDOMISED DOUBLE-BLINDED 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 Sarathi Vin |
| Designation |
Assistant Professor - Dept. of Conservative Dentistry and Endodontics |
| Affiliation |
T.P.C.Ts Terna Dental College and Hospital |
| Address |
Room 205, 2nd Floor, Plot No. 12, Terna Campus Rd, opposite. Nerul Railway Station stn, Sector-22, Nerul West, Navi Mumbai - 400706
B-1703, B-wing, Bolivian Alps, Ivory Towers CHS, Bhakti Park, Near IMAX theatre, Wadala EAST, Mumbai 400037
Thane
MAHARASHTRA
400037
India |
| Phone |
9819503785 |
| Fax |
|
| Email |
sarathi.vin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarathi Vin |
| Designation |
Assistant Professor - Dept. of Conservative Dentistry and Endodontics |
| Affiliation |
T.P.C.Ts Terna Dental College and Hospital |
| Address |
Room 205, 2nd Floor, Plot No. 12, Terna Campus Rd, opposite. Nerul Railway Station stn, Sector-22, Nerul West, Navi Mumbai - 400706
Thane
MAHARASHTRA
400037
India |
| Phone |
9819503785 |
| Fax |
|
| Email |
sarathi.vin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarathi Vin |
| Designation |
Assistant Professor - Dept. of Conservative Dentistry and Endodontics |
| Affiliation |
T.P.C.Ts Terna Dental College and Hospital |
| Address |
Room Number 205, 2nd Floor, Plot No. 12, Terna Campus Rd, opposite. Nerul Railway Station stn, Sector-22, Nerul West, Navi Mumbai - 400706
Thane
MAHARASHTRA
400037
India |
| Phone |
9819503785 |
| Fax |
|
| Email |
sarathi.vin@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sarathi Vin |
| Address |
B-1703, Bolivian Alps, Ivory Towers CHS; Bhakti Park, Wadala EAST, Mumbai - 400037. |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Sarathi Vin |
Terna Dental College & Hopsital |
Room Number 205, 2nd Floor, Plot No. 12, Terna Campus Road, opposite Nerul Railway Station, Sector 22, Nerul West, Navi Mumbai 400706
Thane
MAHARASHTRA |
9819503785
sarathi.vin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| T.P.C.Ts TERNA DENTAL COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, (2) ICD-10 Condition: K041||Necrosis of pulp, (3) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AgNP – Chitosan NP nanoparticle irrigation regimen @ Cryotherapy Temperatures (NPCr) |
AgNP Solution at 2ºC-4ºC.; 0.9% Physiologic Saline at 2ºC-4ºC.; Nano-Chitosan at Room temperature at 2ºC-4ºC. |
| Intervention |
AgNP – Chitosan NP nanoparticle irrigation regimen @ Room Temperature (NPRt) |
AgNP Solution at Room temperature; 0.9% Physiologic Saline at Room temperature; Nano-Chitosan at Room temperature. |
| Intervention |
Standard Irrigation Regimen @ Cryotherapy Temperatures (StdCr) |
5.25% NaoCl at 2.5ºC; 0.9% Physiologic Saline at 2.5ºC; 17% EDTA Liquid at 2.5ºC
|
| Comparator Agent |
Standard Irrigation Regimen @ Room Temperature (StdRt) |
5.25% NaOCl at Room temperature; 0.9% Physiologic Saline at Room temperature; 17% EDTA Liquid at Room temperature |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Mature, Permanent Premolar or Molar Teeth requiring
endodontic treatment.
2. Pulpal and Periapical Diagnoses – 1. Symptomatic irreversible pulpitis (SIP); 2. Symptomatic irreversible pulpitis (SIP) with Symptomatic Apical Periodontitis (SAP); 3. Symptomatic Apical Periodontitis (SAP) without Symptomatic irreversible pulpitis (SIP); 4. Pulpal Necrosis (PN) with Symptomatic Apical Periodontitis (SAP). |
|
| ExclusionCriteria |
| Details |
1. Morbid Individuals with Systemic Diseases.
2. Individuals in gestational or lactation period.
3. Aberrant root canal anatomies.
4. Pulp Space Calcifications.
5. Badly Broken-down teeth.
6. Secondary endodontic infection
7. Periodontally compromised teeth.
8. Rubber dam isolation not possible. |
|
|
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-operative pain on Visual Analogue Scale (VAS) |
Immediate Post-Op, at 6 hours, 12 hours, 24 hours, 72 hours and 1 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post operative pain |
one week postoperatively |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/01/2026 |
| 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="4"
Months="0"
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
|
Aim - To compare and evaluate the post operative pain reduction in cryotherapy and/or Silver NP – Chitosan NP nanoparticle irrigation regimen with the standard irrigation regimen in individuals needing endodontic treatment.
Objectives - 1) Compare and evaluate post operative pain after endodontic treatment done with standard irrigation regimen at cryotherapy temperatures and room temperature. 2) Compare and evaluate post operative pain after endodontic treatment done with Silver NP – Chitosan NP nanoparticle irrigation regimen at cryotherapy temperatures and room temperature.
3) Compare and evaluate post operative pain after endodontic treatment done with Silver NP – Chitosan NP nanoparticle irrigation regimen and standard irrigation regimen, at room temperature.
4) Compare and evaluate post operative pain after endodontic treatment done with Silver NP – Chitosan NP nanoparticle irrigation regimen and standard irrigation regimen, at cryotherapy temperature.
5) Compare anti-microbial effectiveness of Silver NP – Chitosan NP nanoparticle irrigation regimen with standard irrigation regimen in infected teeth requiring endodontic treatment.
Hypothesis - There is a difference in post-operative pain reduction between individuals receiving endodontic treatment with cryotherapy and/or Silver NP – Chitosan NP nanoparticle irrigation regimen & standard irrigation regimen. |