| CTRI Number |
CTRI/2020/09/027635 [Registered on: 07/09/2020] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation on post treatment pain in patients undergoing Root Canal Treatment with 3 agents Lignocaine,sodium Diclofenac, Ketorolac tromethamine. |
|
Scientific Title of Study
|
A Comparative Evaluation Of Anesthetic Efficiency Of
Nerve Block Along With Adjuvant Intraligamentary Injection Of lignocaine, Diclofenac sodium And Ketorolac Tromethamine On Reduction Of Intra Appointment Endodontic Pain In Normal And Hypertensive Patients With Irreversible Pulpitis - A Randomized Clinical Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghna A Kothari |
| Designation |
Post graduate student |
| Affiliation |
Dept of Conservative Dentistry and Endodontics K M Shah Dental College And Hospital |
| Address |
Indrasagar Bhagirath colony near shiv colony stop at and post Jalgaon
Room No 8 First floor, Dept of Conservative dentistry and Endodntics, K M shah denatal college and hospital sumandeep vidyapeeth, waghodia road waghodia,pipariya
Jalgaon
MAHARASHTRA
425001
India |
| Phone |
9823008220 |
| Fax |
|
| Email |
meghnakothari13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha C Shah |
| Designation |
Professor, and Head of the department |
| Affiliation |
dept of conservative dentistry and endodontics K M Shah Dental College And Hospital |
| Address |
Dept of Conservative dentistry and Endodntics, K M shah denatal college and hospital sumandeep vidyapeeth, waghodia road waghodia,pipariya
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghna A Kothari |
| Designation |
Post graduate student |
| Affiliation |
dept of conservative dentistry and endodontics K M Shah Dental College And Hospital |
| Address |
Room No 8 First floor, Dept of Conservative dentistry and Endodntics, K M shah denatal college and hospital sumandeep vidyapeeth, waghodia road waghodia,pipariya
Room No 8 First floor, Dept of Conservative dentistry and Endodntics, K M shah denatal college and hospital sumandeep vidyapeeth, waghodia road waghodia,pipariya
Vadodara
GUJARAT
391760
India |
| Phone |
9823008220 |
| Fax |
|
| Email |
meghnakothari13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of conservative dentistry and endodontics, kM shah dental college and hospital,sumandeep vidyapeeth, vadodara |
|
|
Primary Sponsor
|
| Name |
Dr Meghna Kothari |
| Address |
Indrasagar Bhagirath colony near Shiv colony stop at and post Jalgaon,Maharashtra 425001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr Meghna Kothari |
Dept of Conservative dentistry and Endodntics, K M shah denatal college and hospital |
Room No 8 First floor, Dept of Conservative dentistry and Endodntics, K M shah denatal college and hospital
sumandeep vidyapeeth,
waghodia road
waghodia,pipariya
Vadodara
GUJARAT |
9823008220
meghnakothari13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeep vidyapeeth institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anesthetic Agent |
cartridge of lignocaine without adrenaline(1:200000).
to inject 0.06ml into four sites so 0.24 ml per tooth
|
| Intervention |
Non Steroidal Anti-inflammatory Drug |
Cartridge of diclofenac sodium 30mg/ml.
to inject 0.06ml into four sites so 0.24 ml per tooth |
| Intervention |
Non Steroidal Anti-inflammatory Drug |
Cartridge ofketorolac tromethamine(30mg/ml). to inject 0.06ml into four sites so 0.24 ml per tooth |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients between 18 to 60 years of age with mandibular teeth where mandibular nerve block is required to anesthetize the tooth.
2. Patients diagnosed with irreversible pulpitis with hot tooth.
3. Patients having history of stage 1 and 2 hypertension and undergoing regular treatment.
4. Patients having no systemic diseases other hypertension would be included.
5. Patient should have actively experiencing moderate to severe pain on VAS scale of 5 or more.
6. Teeth with no well defined periapical radiolucency seen on radiographic examination.
7. Patients with history of previous initiation root canal therapy.
8. A written informed consent will be taken from all the patients and only those patients ready to sign the consent letter
|
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity to diclofenac sodium, ketorolac tromethamine and lignocaine.
2. Patients who are pregnant or lactating
3. Patients who are contraindicated for NSAIDs
4. Patients who have undergone cardiac surgery in last 6 months
5. Patients with fractured or visibly cracked tooth, developmental anomalies, pathology or open apex related to study teeth.
6. Patients who had taken NSAIDS within 24 hrs before administration of study drug.
(antibiotic as such no criteria required)
 
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraligamentary Injections are known to reduce the pain after giving nerve block in cases of irreversible pulpitis. The generally used agent is lignocaine but other drugs like diclofenac sodium and ketorolac tromethamine are also proved to reduce the intra-appointment pain |
At Baseline and
Second after getting drop inside the pulp chamber |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate post operative pain following Intraligamentry Injection using lignocaine, diclofenac sodium, ketorolac tromethamine |
At Baseline
and
Second after gaining access to pulp chamber |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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 1 |
|
Date of First Enrollment (India)
|
09/09/2020 |
| 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
Modification(s)
|
Years="0"
Months="2"
Days="29" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Introduction:-Pain of endodontic origin is of concern to both the patient and the clinician. The expectation of a painful experience can increase the patient’s anxiety levels, making treatment more difficult. Management of endodontic pain is one of the challenging aspects in endodontics. Aim:-A comparative evaluation of anesthetic efficiency of nerve block along with adjuvant intraligamentary injection of lignocaine, diclofenac sodium, and ketorolac tromethamine on reduction of the intra appointment endodontic pain in normal and hypertensive patients with irreversible pulpitis. Materials and Methods: 198 patients were randomly allocated into three groups. Group 1 – hypertensive patients with irreversible pulpitis, Group B – healthy individuals with irreversible pulpitis . Preoperative VAS scale was recorded. The IANB nerve block was given to all the allotted patients and intraligamnetry injection od either lignocaine, diclofenac sodium, or ketorolac tromethamine was injected before access opening before the start of the procedure, while the intraligamentary injection was administered before commencing the endodontic. access opening was carried out. The visual analog scale (VAS) was used to evaluate the pain score at baseline and after getting drop into the pulp chamber
results:-There Is a Statistically Significant Difference Seen between Diclofenac Sodium And Ketorolac Tromethamine within and inter Group 1 and group2 while no Statistically Significant Difference Seen When Compared To Lignocaine Among Group1 And Group2. |