| CTRI Number |
CTRI/2024/05/067990 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of antimicrobial efficiency of three different irrigating solutions in single rooted non vital teeth |
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial efficacy of Triton, nine percent HEDP and three percent Sodium Hypochlorite solution as a root canal irrigant in single rooted 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.Chandni Shah |
| Designation |
PG Student |
| Affiliation |
K.M.Shah Dental College And Hospital |
| Address |
8,Department of Conservative Dentistry and Endodontics,
K.M. Shah Dental College and Hospital,
Sumandeep Vidyapeeth,
Waghodia road,
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9427439376 |
| Fax |
|
| Email |
drchandni138@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vishnu Pratap Singh Rathore |
| Designation |
Professor And PG Guide |
| Affiliation |
K.M. Shah Dental College And Hospital |
| Address |
8,Department of Conservative Dentistry and Endodontics,
K.M. Shah Dental College and Hospital,
Sumandeep Vidyapeeth,
Waghodia road,
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7575071175 |
| Fax |
|
| Email |
dr.vishnurathore84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vishnu Pratap Singh Rathore |
| Designation |
Professor And PG Guide |
| Affiliation |
K.M. Shah Dental College And Hospital |
| Address |
8,Department of Conservative Dentistry and Endodontics,
K.M. Shah Dental College and Hospital,
Sumandeep Vidyapeeth,
Waghodia road,
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7575071175 |
| Fax |
|
| Email |
dr.vishnurathore84@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.M. Shah Dental College and Hospital,Sumandeep Vidyapeeth,Waghodia,Vadodara |
|
Primary Sponsor
Modification(s)
|
| Name |
KMShah Dental college and Hospital |
| Address |
8,Department of Conservative Dentistry and Endodontics,
K.M. Shah Dental College and Hospital,
Sumandeep Vidyapeeth,
Waghodia,
Vadodara |
| 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 Chandni Shah |
K.M. Shah Dental College And Hospital |
Department of Conservative Dentistry and Endodontics,
K.M. Shah Dental College and Hospital,
Sumandeep Vidyapeeth,
Waghodia,
Vadodara
Vadodara
GUJARAT |
9427439376
drchandni138@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 |
| Healthy Human Volunteers |
SINGLE ROOTED NON VITAL TEETH |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3% SODIUM HYPOCHLORITE SOLUTION |
Tissue dissolvent and commonly used irrigating agent.A total of 10 ml of solution will be used during instrumentation of canal for 5 to 10 mins. |
| Intervention |
9% HEDP |
2.5% OF NAOCL AND 9% HEDP is mixed together prior to its use to form a single solution for final irrigation.• A total of 10 ml of solution will be used during instrumentation of canal fir 5 to 10 mins. |
| Intervention |
TRITON |
The solution comprises two distinct parts: Part A includes chelators (CA), surfactants, pH modifiers, and stabilizers, while Part B contains 8% NaOCl and a pH modifier. Through an automix technique, these two parts are precisely mixed at 1:1 volume ratio to create the final solution, resulting in a 4% NaOCl concentration.A total of 10 ml of solution will be used during instrumentation of canal for 5 to 10 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.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 non vital single rooted teeth containing single canal .
3. Maxillary or mandibular teeth having Periapical Index (PAI)Score1 and 2 (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.Teeth with open apex, root resorption and calcified pulp chamber and canals will be excluded from the study.
2.Teeth with curvature more than 20 degree (according to Schnieder’s classification ) will be excluded from the study.
3.Teeth which had received previous endodontic treatment will be excluded from the study.
4.Pregnant and lactating mothers will be excluded from the study.
5.Teeth with developmental anomaly or pathology or congenital defects will be excluded.
6.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 |
| The result of the study helps us to know the antimicrobial efficacy of three diferent irrigating solutions which are triton,9% HEDP and 3% Sodium Hypochlorite Solution by taking pre and post irrigation samples and then after collection of samples assessing them by formation of growth of mean colony forming units. |
48 to 72 hours from the day of collection of sample. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
25/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 Triton,9% HEDP and 3% Sodium Hypochlorite solution as a root canal irrigant in single rooted non- vital teeth:A Randomized Double Blinded Clinical Study. The result of this study will help us to know about the antimicrobial efficacy of Triton as all in one irrigating solution. It also aims for comparative evaluation of antimicrobial efficacy of Triton,9%HEDP,3% Sodium Hypochlorite solution which will help practitioners to decide which root canal irrigant is most effective. |