| CTRI Number |
CTRI/2024/05/067190 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Other (Specify) [Irrigating Solution: 9% HEBP (mild cheelator) and 2.5% Sodium Hypocholrte] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A post-operative pain evaluation with Ultrasonic activation and laser irradiation using continuous chelation irrigant solution in symptomatic irreversible pulpitis teeth A Randomized Clinical Study |
|
Scientific Title of Study
|
A comparative evaluation of post-operative pain with Ultrasonic activation and laser irradiation using irrigation of 9 % etidronate & 2.5% NaOCl mixed solution in symptomatic irreversible pulpitis teeth 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 |
Vinaya pisal |
| Designation |
post graduate student |
| Affiliation |
KM Shah Dental College and Hospital Sumandeep Vidyapeeth |
| Address |
Department of conservative dentistry and endodontics, KM Shah Dental College, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9607086688 |
| Fax |
|
| Email |
vinayapisal99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Batra |
| Designation |
PG Guide |
| Affiliation |
KM Shah Dental College and Hospital Sumandeep Vidyapeeth |
| Address |
Department of conservative dentistry and endodontics, KM Shah Dental College, Vadodara, Gujarat
GUJARAT
391760
India |
| Phone |
9607086688 |
| Fax |
|
| Email |
drrenubatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinaya pisal |
| Designation |
post graduate student |
| Affiliation |
KM Shah Dental College and Hospital Sumandeep Vidyapeeth |
| Address |
Department of conservative dentistry and endodontics, KM Shah Dental College, Vadodara, Gujarat
GUJARAT
391760
India |
| Phone |
9607086688 |
| Fax |
|
| Email |
vinayapisal99@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM Shah Dental College and Hospital, Vadodara |
|
|
Primary Sponsor
|
| Name |
Dr Vinaya Pisal |
| Address |
KM shah Dental college & hospital, vadodara, gujarat |
| Type of Sponsor |
Other [self funded] |
|
|
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 Vinaya Pisal |
KM Shah Dental College and Hospital |
Department of conservative dentistry and endodontics, KM shah Dental college, vadodara
Vadodara
GUJARAT |
9607086688
vinayapisal99@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: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
980nm Diode laser |
after irrigation protocol root canal will be disinfected with the help of laser tip inside the canal foe 10 sec likely 3 cycles will be performed. |
| Intervention |
Ultrasonic activation |
irrgation solution will be activated with the help of ultrasonic activator for 1min. |
|
|
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 teeth diagnosed with Symptomatic irreversible pulpitis with or without periapical pathology or radiographic rarefaction.
3. 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 will be excluded from the study
3. patients taking analgesics 12 hours before the intervention.
4. Teeth which had received previous endodontic treatment will be excluded from the study.
5. Cases showing periodontal pockets deeper than 4mm will be excluded from the study.
6. Teeth with pre-op swelling, draining sinus and Flare ups during root canal treatment will be excluded from the study.
7. Any other iatrogenically affected root canal treatments will be excluded from the study.
8. Medically compromised patients will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The result of this study will help us to know about postoperative comfort of patient after ultrasonic activation and 980nm diode laser disinfection with continous chelation protocol. |
preoperative pain score and postoperative at 6, 12, 24 and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know which has better efficacy than the other. |
at post operatively 6hrs, 12hrs, 24hrs, 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
21/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/08/2024 |
|
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
|
Postoperative pain is common complain after root canal treatment which is multifactorial in etiology but majorly caused by mechanical and chemical extrusion in apical third of root canal. with different irrigating solutions and activation protocol it has become even more unpredictable and uncertain. Therefore, for any irrigating solution to be standard it has to be well researched and studied for its clinical efficacy and applicability. for which the basic pattern is to study postoperative pain. Therefore, in this study we are comparing two different techniques of activation and disinfection when using continous chelation protocol which is 9% etidronate and 2.5% Sodium hypochlorite solution as irrigant with ultrasonic activation and diode laser disinfection a randomized control study. |