| CTRI Number |
CTRI/2021/01/030329 [Registered on: 07/01/2021] Trial Registered Prospectively |
| Last Modified On: |
31/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative evaluation of post- op pain after irrigant activation techniques and Conventional needle irrigation |
|
Scientific Title of Study
|
Comparative evaluation of post- operative pain after two irrigant activation techniques with Conventional Needle irrigation – A double blinded randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SwarnaSK |
| Designation |
Post graduate Dental student |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences, Saveetha Dental college |
| Address |
Department of Conservative Dentistry and Endodontics
aveetha Institute of Medical and Technical Sciences
Saveetha Dental College
162, Poonamallee high road
Velappanchavadi
Chennai
162, Poonamallee high road
Velappanchavadi
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9344766417 |
| Fax |
|
| Email |
swarkarthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nivedhitha MS |
| Designation |
Head of the Department |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences, Saveetha Dental college |
| Address |
Department of Conservative Dentistry and Endodontics
Saveetha Institute of Medical and Technical Sciences, Saveetha Dental college
162, Poonamallee high road
Velappanchavadi
Chennai
162, Poonamallee high road
Velappanchavadi
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9840912367 |
| Fax |
|
| Email |
nivedhithamallisureshbabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivedhitha MS |
| Designation |
Head of the Department |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences, Saveetha Dental college |
| Address |
Department of Conservative Dentistry and Endodontics
Saveetha Institute of Medical and Technical Sciences, Saveetha Dental college
162, Poonamallee high road
Velappanchavadi
Chennai
162, Poonamallee high road
Velappanchavadi
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
99840912367 |
| Fax |
|
| Email |
nivedhithamallisureshbabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sai Ram Institutions- Administration Office
Sai Bhavan
No 31 B
Madley road
Ashoka nagar
T Nagar
Chennai |
|
|
Primary Sponsor
|
| Name |
Sai Ram |
| Address |
Sai Bavan, 31B, Madley road
T Nagar
Chennai |
| Type of Sponsor |
Research institution |
|
|
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 |
| NivedhithaMS |
Saveetha Dental College, Saveetha Institue of Medical and Technical Sciences |
Department of Conservative Dentistry and Endodontics
Clinic 21
162, Poonamallee high road
Velappanchavadi
Chennai
TAMIL NADU |
9840912367
nivedhithamallisureshbabu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional needle irrigation |
27 gauge side vented needle |
| Intervention |
Irrigant activation techniques |
Passive ultrasonic irrigation
Laser activated Irrigation
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
Healthy patients
Symptomatic irreversible pulpits
Pain score ranging from moderate to severe 4-10 on VAS scale |
|
| ExclusionCriteria |
| Details |
Patients who had analgesic within last 12 h
Systemic illness
Drug allergy
Pregnancy
Lactation
Calcified canal
Periodontal disease |
|
|
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 |
| Post operative pain after irrigation activation using VAS scale |
After 6, 24, 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between Post operative pain and Analgesic intake in Patients with Symptomatic Irreversible Pulpitis |
After 24 hours |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
18/01/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to compare the post- operative pain after the patients have been subjected to irrigant activation techniques at 6, 24 and 48 hours using visual analogue scale (VAS) from 0-10 and to correlate the intensity of pain and analgesic intake in patients with severe pain. Healthy patients in the age group of 18-65 years of age with symptomatic irreversible pulpitis and pain score from moderate to severe on VAS scale were included in the study. Patients who had analgesic within the last 12 hours were excluded from the study and immunocompromised patients, patients with calcified canal or periodontal disease were excluded from the study. The groups analyzed were conventional needle irrigation, Passive ultrasonic irrigation and Laser activated irrigation. The parameters evaluated were post operative pain after 6, 24 and 48 hours using VAS scale. The correlation between quantity and duration of analgesic intake in patients with severe pain were also evaluated after 24 hours.
|