| CTRI Number |
CTRI/2026/03/106637 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of three medicines used in tooth undergoing root canal treatment. |
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial efficacy of Calcium Hydroxide combined with saline, Calcium Hydroxide combined with 3% sodium hypochlorite and Sodium Dichloroisocyanurate alone as an intracanal medicament in multirooted necrosed 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 Arya Panhalkar |
| Designation |
MDS Student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
Room No.08, Department of Conservative Dentistry and Endodontics, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Campus, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7045405211 |
| Fax |
|
| Email |
dr.aryapanhalkar@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 |
| Address |
Room No.08, Department of Conservative Dentistry and Endodontics, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Campus, Waghodia Road, Piparia, Taluk 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 |
| Address |
Room No.08, Department of Conservative Dentistry and Endodontics, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Campus, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Arya Panhalkar |
| Address |
Room no. 08, Department of Conservative Dentistry and Endodontics, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Campus, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 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 Arya Panhalkar |
K M Shah Dental College and Hopital |
08, Department of Conservative Dentistry and Endodontics, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Campus, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Vadodara
GUJARAT |
7045405211
dr.aryapanhalkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
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 combined with 3% sodium hypochlorite as an intracanal medicament |
Sodium hypochlorite possesses potent antimicrobial and tissue-dissolving properties. When mixed with calcium hydroxide, it provides an additive effect by combining the immediate chlorine-releasing action of sodium hypochlorite with the sustained alkalinity of calcium hydroxide. Sodium hypochlorite solutions are inherently alkaline, and their proteolytic activity is enhanced by the addition of alkali salts such as Calcium Hydroxide. It will be placed in the canal for 7 days. |
| Comparator Agent |
Calcium Hydroxide combined with saline as an intracanal medicament |
Calcium hydroxide has an antimicrobial action is attributed to its high alkalinity, pH 12.5 which causes bacterial protein denaturation, membrane damage, and enzyme inactivation. It will be placed in the canal for 7 days. |
| Intervention |
Sodium Dichloroisocyanurate alone as an intracanal medicament |
Sodium Dichloroisocyanurate releases free available chlorine (FAC), which partly dissociates into hypochlorous acid (HOCl). HOCl exhibits stronger antimicrobial action. It will be placed in the canal for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients (Category: American Society of Anaesthesiologists class 1) (ASA House of Delegates 2014) aged between 18 – 60 years of age will be included.
2.Maxillary or mandibular completely matured multi-rooted tooth, diagnosed with pulp necrosis will be included
3.Maxillary or mandibular teeth having Periapical Index (PAI) Score 2 or more (according to PAI score classification) will be included.
4.Only those patients ready to sign the consent form will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1.Vital teeth, teeth diagnosed with, cracks, internal/external root resorption or pulp canal obliteration and exhibiting clinical and/or radiographic signs of chronic/severe periodontitis 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.
5.Patient not ready to give the consent will be excluded from the study.
|
|
|
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 |
| To evaluate and compare antimicrobial efficacy of Calcium Hydroxide mixed with saline, Calcium Hydroxide mixed with 3% sodium hypochlorite and Sodium Dichloroisocyanurate as an intracanal medicament in multirooted necrosed teeth. |
At baseline and 7 days after the placement of intracanal medicament. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure & compare the MMP-9 levels using a specific enzyme-linked immunosorbent assay in each group. |
7 days after the placement of intracanal medicament |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/04/2026 |
| 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="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 - NO
|
|
Brief Summary
|
To evaluate and compare antimicrobial efficacy of Calcium Hydroxide mixed with saline, Calcium Hydroxide mixed with 3% sodium hypochlorite and Sodium Dichloroisocyanurate paste as an intracanal medicament in multirooted necrosed teeth. This study will help us to know which medicament has the most antimicrobial efficacy when used as an intracanal medicament in multirooted necrosed teeth |