| CTRI Number |
CTRI/2026/02/103075 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares sodium dichloroisocyanurate and calcium hydroxide in killing bacteria during root canal treatment. The medicines are placed inside the tooth between sessions, and bacteria counts are checked before and after. Goal is to see which medicine works better |
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial efficacy of Sodium Dichloroisocyanurate and Calcium Hydroxide as a root canal medicament in non- vital teeth: A Randomized Double Blinded 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 Tanya chopra |
| Designation |
PG STUDENT |
| Affiliation |
K.M. Shah Dental College and Hospital Gujarat |
| Address |
30,shreenath varnan, aava county, waghodia road, vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
09461317232 |
| Fax |
|
| Email |
tanyachopra456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Shah |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
K.M. Shah Dental College and Hospital Gujarat |
| Address |
8 Department of Conservative Dentistry and Endodontics SUMANDEEP VIDYAPEETH, WAGHODIA, VADODARA GUJARAT 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimisha Shah |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
K.M. Shah Dental College and Hospital Gujarat |
| Address |
8 Department of Conservative Dentsitry K M Shah Dental College SUMANDEEP VIDYAPEETH, WAGHODIA, VADODARA GUJARAT 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
|
Source of Monetary or Material Support
|
| 8 Department of Conservative Dentistry and Endodontics KM SHAH DENTAL COLLEGE SUMANDEEP VIDYAPEETH Waghodia Road 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Tanya Chopra |
| Address |
30 Shreenath varnan Aava County, Waghodia road Vadodara 391760 |
| 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 tanya chopra |
K M Shah Dental College Sumandeep Vidyapeeth |
8 Department of conservative Dentistry and Endodontics
Vadodara
GUJARAT |
09461317232
tanyachopra456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidhyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium Hydroxide |
To evaluate and compare antimicrobial efficacy of Sodium Dichloroisocyanurate and Calcium Hydroxide as a root canal medicament in non- vital teeth (in terms of colony forming unit). Duration of intervention is 7 days |
| Intervention |
Sodium Dichloroisocyanurate |
To evaluate and compare antimicrobial efficacy of Sodium Dichloroisocyanurate and Calcium Hydroxide as a root canal medicament in non- vital teeth (in terms of colony forming unit). Duration of intervention is 7 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically Healthy patient who will give informed consent will be included.
2. Completely matured multi-rooted tooth, diagnosed with pulp necrosis will be included.
|
|
| ExclusionCriteria |
| Details |
1. Teeth with immature roots, symptomatic irreversible pulpitis, symptomatic reversible pulpitis, those diagnosed with, cracks, internal/external root resorption or pulp canal obliteration and exhibiting clinical and/or radiographic signs of chronic/severe periodontitis or periapical abscess will be excluded.
2. Teeth with previously endodontic treatment will be excluded.
3. Patients with severe periodontitis and poor oral hygiene will be excluded from the study.
4. 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 |
| 3. To compare antimicrobial efficacy of Sodium Dichloroisocyanurate and Calcium Hydroxide as a root canal medicament in non- vital teeth. |
baseline and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="22"
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)
|
14/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Comparative evaluation of antimicrobial efficacy of Sodium Dichloroisocyanurate and Calcium Hydroxide as a root canal medicament in non- vital teeth: A Randomized Double Blinded Clinical Study. The outcome of this study will help the clinician to decide which medicament will provide more reduction in microbial growth of the bacteria. The result of this study will help us to know about the antimicrobial efficacy of Sodium Dichloroisocyanurate as all-in-one intracanal medicament |