| CTRI Number |
CTRI/2025/09/094546 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study in patients needing root canal treatment to compare calcium hydroxide and triple antibiotic paste, with or without silver nanoparticles, for infection control and pain relief. |
|
Scientific Title of Study
|
A comparative evaluation of calcium hydroxide and triple antibiotic paste with and without silver nanoparticles on microbial load and post operative pain: An in vivo 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 Keshav Singla |
| Designation |
Post graduate student |
| Affiliation |
Dasmesh Institute of Research and Dental Sciences, Faridkot |
| Address |
Department of Conservative dentistry and Endodontics Room number 7 Dasmesh Institute of Research and Dental Sciences Talwandi Road Faridkot 151203
Faridkot
PUNJAB
151203
India |
| Phone |
9878269564 |
| Fax |
|
| Email |
ksingla97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun Kumar |
| Designation |
Professor |
| Affiliation |
Dasmesh Institute of Research and Dental Sciences, Faridkot |
| Address |
Department of Conservative dentistry and Endodontics Room number 7 Dasmesh Institute of Research and Dental Sciences Talwandi Road Faridkot 151203
Faridkot
PUNJAB
151203
India |
| Phone |
9888666699 |
| Fax |
|
| Email |
drtarunkumar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tarun Kumar |
| Designation |
Professor |
| Affiliation |
Dasmesh Institute of Research and Dental Sciences, Faridkot |
| Address |
Department of Conservative dentistry and Endodontics Room number 7 Dasmesh Institute of Research and Dental Sciences Talwandi Road Faridkot 151203
PUNJAB
151203
India |
| Phone |
9888666699 |
| Fax |
|
| Email |
drtarunkumar@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dasmesh Institute of Research and Dental Sciences Talwandi Road Faridkot 151203 |
|
|
Primary Sponsor
|
| Name |
Dr. Keshav Singla |
| Address |
Dasmesh Institute of Research and Dental Sciences Talwandi Road Faridkot 151203 |
| 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 Keshav Singla |
Dasmesh Institute of Research and Dental Sciences |
Department of Conservative dentistry and Endodontics Room number 7
Faridkot
PUNJAB |
9878269564
ksingla97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcium hydroxide with silver nanoparticles. |
Intracanal medicament consisting of calcium hydroxide with silver nanoparticles placed inside the root canal for 7 days after the biomechanical preparation. |
| Intervention |
Calcium hydroxide without silver nanoparticles. |
Intracanal medicament consisting of calcium hydroxide without silver nanoparticles placed inside the root canal for 7 days after the biomechanical preparation. |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Triple antibiotic paste with silver nanoparticles. |
Intracanal medicament consisting of triple antibiotic paste with silver nanoparticles placed inside the root canal for 7 days after the biomechanical preparation. |
| Intervention |
Triple antibiotic paste without silver nanoparticles. |
Intracanal medicament consisting of triple antibiotic paste without silver nanoparticles placed inside the root canal for 7 days after the biomechanical preparation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects which have non-contributory medical history.
2. Teeth with pulpal necrosis and periapical pathosis will be selected, PAI score more than 2 less than 5.
3. Teeth with enough crown structure for adequate isolation with rubber dam.
4. Teeth with favourable root morphology
5. Teeth that are restorable.
6. Teeth with completely formed apices and without internal resorption will be selected.
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients or patients who are allergic to drugs.
2. PAI score equal to or more than 5.
3. Pregnant females
4. Patients with Immunocompromising disorders.
5. Teeth with abscess, fistula or sinus tract, previously root canal treated teeth.
6. Grade I mobility or pocket depth more than 5 mm or radiographic evidence of external or internal root resorption.
7. Teeth that are unrestorable.
8. Antibiotics use within the past 30 days and patients who have some general disease.
9. Teeth with incompletely formed apices and internal resorption.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial load reduction and impact on post operative pain. |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antimicrobial efficacy of calcium hydroxide, as an intracanal medicament with and without silver nanoparticles. |
1 year 6 months |
| Antimicrobial efficacy of triple antibiotic paste, as an intracanal medicament with and without silver nanoparticles. |
1 year 6 months |
| Post-operative pain following the use of calcium hydroxide as an intracanal medicament, with and without the addition of silver nanoparticles. |
1 year 6 months |
| Post-operative pain following the use of triple antibiotic paste as an intracanal medicament, with and without the addition of silver nanoparticles. |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 18-09-2025 and end date provided 02-02-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Postoperative pain primarily results from
microorganisms in the root canal system. Since mechanical instrumentation alone
may not eliminate all bacteria, intracanal medicaments are recommended. Calcium
hydroxide is the most commonly used medicament, while triple antibiotic paste
(TAP) is another effective option. Recently, silver nanoparticles have gained
attention for their antimicrobial properties. The purpose of this in vivo study
is to evaluate and compare the reduction in microbial load and postoperative
pain scores associated with the use of calcium hydroxide and triple antibiotic
paste (TAP), both with and without silver nanoparticles. This study is a
randomised, double blind, parallel group, study comparing and evaluating the
microbial load reduction and effect on post-operative pain of calcium hydroxide
and triple antibiotic paste with and without silver nanoparticles.
|