| CTRI Number |
CTRI/2024/03/063846 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A clinical Trial To Study Efficacy Of Analgesics like Ibuprofen,Ketorolac and Diclofenac Sodium in painful endodontically involved tooth |
|
Scientific Title of Study
|
Evaluation Of Efficacy Of Analgesics In Patients With Symptomatic Apical Periodontitis In Terms Of Number Needed To Treat: A Double Blind Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manju Kumari |
| Designation |
Professor |
| Affiliation |
Chaudhary Charan Singh University |
| Address |
ITS Dental College Hospital and Research Centre
47 Knowledge Park III
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
09811056881 |
| Fax |
|
| Email |
docmanjukmr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MANJU KUMARI |
| Designation |
PROFESSOR |
| Affiliation |
CHAUDHARY CHARAN SINGH UNIVERSITY |
| Address |
ITS DENTAL COLLEGE HOSPITALS AND RESEARCH CENTRE
47 KNOWLEDGE PARK III
GREATER NOIDA
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
09811056881 |
| Fax |
|
| Email |
docmanjukmr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanisha Singh |
| Designation |
Postgraduate |
| Affiliation |
Chaudhary Charan Singh University |
| Address |
ITS dental college hospitals and research centre
47 Knowledge Park III
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
09811056881 |
| Fax |
|
| Email |
docmanjukmr@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS Dental College, Greater Noida |
|
|
Primary Sponsor
|
| Name |
Manju Kumari |
| Address |
ITS Dental college and Hospital Research Centre
47 Knowledge Park III
GREATER NOIDA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rohit Kochhar |
ITS Dental College Hoplpitals and Research Centre
47 Knowledge Park III |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manju Kumari |
ITS DENTAL COLLEGE,HOSPITALS&RESEARCH CENTRE |
Room No: 7, Department of Conservative Dentistry & Endodontics,47,knowledge park III
greater noida
uttarpradesh
201310
Gautam Buddha Nagar
UTTAR PRADESH |
9811056881
docmanjukmr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
symptomatic apical periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control intervention |
ibuprofen 400 mg
1 tab to be taken after completion of first appointment
Ketorolac 10 mg
1 tab to be taken after completion of first appointment
diclofenac sodium 100mg
1 tab to be taken after completion of first appointment
Placebo
1 tab of sugar pill to be taken after completion of first appointment
|
| Intervention |
Drugs |
ibuprofen 400 mg
Ketorolac 10 mg
diclofenac sodium 100mg
Placebo |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient with symptoms of AAP, without periapical lesion, with or without PDL widening if he/she placed a mark at the 4cm or above level and patient undergoing root canal treatment for pain originating from anterior or posterior teeth |
|
| ExclusionCriteria |
| Details |
patients with less than 16 years or more than 65 years, patients who have consumed any type of analgesic within the last 6 h of their visit, history of allergy to NSAIDs, history of peptic ulcer disease, history of renal or hepatic disease, hemorrhagic disorders, pregnancy or breast feeding, patients with previous endodontic treatment and patients with acute apical abscess |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| number needed to treat |
After 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of different drugs at different time point |
6,12,24,48 and 72 hours |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
27/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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
|
The aim of the study is to use the NNT (number needed to treat) model to evaluate the efficacy of analgesics in patients with acute apical periodontitis. Material and Methods : Patients with acute apical periodontitis (AAP) without periapical lesion, with or without PDL widening if he/she placed a mark at the 4cm or above level will be selected for the study at the dental institute. The patients were randomly allocated into 4 groups of 50 patients in each group, receiving ibuprofen 400 mg in Group B, ketorolac 10 mg in Group C and diclofenac sodium 100 mg in Group D and a control in Group A in which placebo will be given just after the completion of first appointment. A questionnaire containing the NRS will be given to each patient for them to record the intensity of pain felt after 6, 12, 24, 48 and 72 hrs interval. |