CTRI Number |
CTRI/2020/02/023261 [Registered on: 11/02/2020] Trial Registered Prospectively |
Last Modified On: |
29/01/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
to achieve maximum anaesthetic success using ketorolac and pregabalin premedication with 1.7mL of articaine using Inferioor alveolar block with infiltration in symptomatic teeth |
Scientific Title of Study
|
Comparative Evaluation of Anaesthetic Success after Ketorolac and Pregabalin Oral Premedication for Inferior Alveolar Nerve Block with Buccal Infiltration in Symptomatic Mandibular Molars with Irreversible Pulpitis-- A Prospective, Randomized, Controlled, Double-Blind 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 Suruchi Agrawal |
Designation |
Post Graduate Student |
Affiliation |
SGT Dental College |
Address |
Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences,SGT University Chandu-Budhera, Gurgaon-Badli road, Gurugram Gurgaon HARYANA 122505 India |
Phone |
8955997107 |
Fax |
|
Email |
suru.34@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mandeep S Grewal |
Designation |
Head of Department |
Affiliation |
SGT Dental College |
Address |
Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University Chandu-Budhera, Gurgaon-Badli road, Gurugram Gurgaon HARYANA 122505 India |
Phone |
9810805880 |
Fax |
|
Email |
drmandeepsgrewal@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Suruchi Agrawal |
Designation |
Post Graduate Student |
Affiliation |
SGT Dental College |
Address |
Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University Chandu-Budhera, Gurgaon-Badli road, Gurugram Gurgaon HARYANA 122505 India |
Phone |
8955997107 |
Fax |
|
Email |
suru.34@gmail.com |
|
Source of Monetary or Material Support
|
self sponsored
Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT Dental College, SGT University |
|
Primary Sponsor
|
Name |
dr suruchi agrawal |
Address |
sgt dental college, dept of conservative dentistry and endodontics, faculty of dental sciences,chandu-budhera, gurgaon-badli road, gurugram |
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 Suruchi Agrawal |
SGT Dental College |
Dept of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, Chandu-Budhera, Gurgaon-Badli road, Gurugram Gurgaon HARYANA |
8955997107
suru.34@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Dr Poonam Salwan, Mr Dinesh, Mr Azad Singh, Dr Anil Gupta, Dr Mandeep S Grewal, Mrs Achinder Chauhan |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
irreversible pulpitis |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
articaine is used |
The dentist administering the local anesthetic agent.The access opening and instrumentation will be assigned to different dentist. |
Comparator Agent |
nil |
nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1 Symptomatic irreversible pulpitis
2 Patients with active pain in a mandibular first or/and second molar,
3 Patients in good health, with no previous history of allergy to any kind of local anesthesia, sulphites or other drugs that would alter pain perception.
4 Prolonged response to cold testing with Endo-frost (Roeko Langenace, Germany)
5 Absence of any periapical radiolucency on periapical radiographs
6 A vital coronal pulp on access opening.
|
|
ExclusionCriteria |
Details |
1 Subjects younger than 18 years and older than 60
2 History of significant medical problems
3 Taken central nervous system depressants or any analgesic medication within 8 hours
4 Pregnancy
5 Allergy to articaine, ketorolac, pregabalin
6 Unable to give informed consent.
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
compare the effect of oral premedication with ketorolac and pregabalin on anesthetic efficacy of inferior alveolar nerve block and buccal infiltration in symptomatic patients with irreversible pulpitis |
pain assessment done at 15 minutes |
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
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
|
N/A |
Date of First Enrollment (India)
|
15/02/2020 |
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
|
Years="0" Months="3" 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)?
|
Brief Summary
|
This is a prospective, randomized, controlled, double blind study will be to achieve maximum anaesthetic success using ketorolac and pregabalin premedication with 1.7mL of articaine IANB with BI in teeth with symptomatic IP. Sample size of this trial is 150 which is divided into three groups of 50 each. All patients will be asked to rate the pain on the HP VAS to analyse the level of pain during access opening and after instrumentation. |