| CTRI Number |
CTRI/2024/06/068268 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing antibacterial action and in-between appointment pain of 3% sodium hypochlorite as root canal irrigant at different temperatures in necrotic teeth. |
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial efficacy and Inter-appointment pain with 3% sodium hypochlorite at different intracanal temperatures in teeth with Pulp necrosis with Symptomatic Apical periodontitis- A Randomized 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 Shreya Volety |
| Designation |
Post-graduate student |
| Affiliation |
K.M Shah dental college and hospital |
| Address |
Room NO.8 Department of Conservative Dentistry and Endodontics
Sumandeep Vidyapeeth Pipariya Waghodia Road
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
09982672855 |
| Fax |
|
| Email |
shreyavolety19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Singh Rao |
| Designation |
Professor and PG Guide |
| Affiliation |
K.M Shah Dental college and hospital |
| Address |
Room NO.8 Department of Conservative Dentistry and Endodontics
Sumandeep Vidyapeeth Pipariya Waghodia Road
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
838501730 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Singh Rao |
| Designation |
Professor and PG Guide |
| Affiliation |
K.M Shah Dental college and hospital |
| Address |
Room NO.8 Department of Conservative Dentistry and Endodontics
Sumandeep Vidyapeeth Pipariya Waghodia Road
Vadodara
GUJARAT
391760
India |
| Phone |
838501730 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room NO.8 Department of Conservative Dentistry and Endodontics Sumandeep Vidyapeeth Pipariya Waghodia Road
Vadodara 391760
Gujarat
India |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Volety |
| Address |
Room NO.8 Department of Conservative Dentistry and Endodontics
Sumandeep Vidyapeeth Pipariya Waghodia Road
Vadodara 391760
Gujarat
India |
| 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 Shreya Volety |
K M Shah Dental College and Hospital |
Room NO.8 Department of Conservative Dentistry and Endodontics
Sumandeep Vidyapeeth Pipariya Waghodia Road
Vadodara
Vadodara
GUJARAT |
09982672855
shreyavolety19@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 |
3% Sodium Hypochlorite at temperature of 2ËšC |
To evaluate the anti-microbial efficacy and inter-appointment pain of 3% sodium hypochlorite as root canal irrigant at a temperature of 2ËšC in necrotic teeth with symptomatic apical periodontitis |
| Comparator Agent |
3% Sodium Hypochlorite at temperature of 37ËšC |
To evaluate the anti-microbial efficacy and inter-appointment pain of 3% sodium hypochlorite as root canal irrigant at a temperature of 37ËšC in necrotic teeth with symptomatic apical periodontitis |
| Intervention |
3% Sodium Hypochlorite at temperature of 45ËšC |
To evaluate the anti-microbial efficacy and inter-appointment pain of 3% sodium hypochlorite as root canal irrigant at a temperature of 45ËšC in necrotic teeth with symptomatic apical periodontitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy patients (Category: American Society of Anesthesiologists class 1) (ASA House of Delegates 2014) aged between 18 – 60 years of age with teeth diagnosed with pulp necrosis with symptomatic apical periodontitis.
2. Necrotic pulps as confirmed by negative response to sensitivity pulp tests.
3. Teeth with symptomatic apical periodontitis
4. Teeth with or without periapical radiolucency size less than 2 mm.
5. A written informed consent will be obtained from all the patients and only those
Patients who are ready to sign the consent form will be included in the study |
|
| ExclusionCriteria |
| Details |
Patients suffering from a significant systemic condition.
2. Patients who received antibiotic therapy within the previous 3 months
3. Teeth with calcified pulp chamber
4. Teeth that had received previous endodontic treatment
5. Cases showing periodontal pockets deeper than 4mm.
6. Patients on medications such as chemotherapy, anticoagulants, corticosteroids,
bisphosphonates and immunosuppressant drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of this study will help us to know about the antimicrobial efficacy of 3% sodium hypochlorite at different temperature |
baseline, 6hrs, 12hrs, 24hrs, 48hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To know about the inter-appointment pain of
Triphala versus 3% sodium
hypochlorite as root canal irrigant in teeth with necrotic pulp |
within 7 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/06/2024 |
| Date of Study Completion (India) |
07/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Sodium hypochlorite (NaOCl) is the most common irrigant used in endodontics because of its
antibacterial and physicochemical properties and its unique ability to dissolve necrotic tissue
remnants. Mechanical instrumentation and NaOCl irrigation have been shown to dramatically
reduce the bacterial load in the root canal system. Unfortunately, irrigation with NaOCl during
chemo-mechanical debridement does not always result in bacteria-free root canals. In teeth with symptomatic apical periodontitis, patients undergoing cryotherapy
treatment exhibited a significant reduction in inter-appointment pain levels compared to the
control group.5 So far, the effect of different concentrations or temperatures of sodium
hypochlorite on pain after endodontic treatment has been investigated. Consequently, there are
no clinical studies to support the use of preheated NaOCl for root canal irrigation. Therefore,
the research question of this study is to evaluate whether the effect of 3% sodium hypochlorite
at different intracanal temperatures would result in a difference in antimicrobial efficacy and
inter-appointment pain in teeth with Pulp necrosis with symptomatic apical periodontitis
treated in two visits.
The result of this study will help us to know about the antibacterial efficacy of cryotherapy
with sodium hypochlorite as a root canal irrigant |