| CTRI Number |
CTRI/2017/03/007995 [Registered on: 02/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare the effects of three different painkillers on reliving pain in patients undergoing braces treatment. |
|
Scientific Title of Study
|
A Comparison between Acetaminophen, Ibuprofen and Ketorolac as an Efficient Single Dose Preoperative Medication for Control of Pain Associated with Initial Aligning Archwire: A Double Blind Randomised Control Trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nimish Wajekar |
| Designation |
Post Graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
2C 701 Neel Park Near Sahasrabuddhe Hospital Swami Nityanand marg Old Panvel
Department of Orthodontics and Dentofacial Orthopedics SMBT Dental College and Hospital Amrutnagar Ghulewadi Sangamner
Raigarh
MAHARASHTRA
410206
India |
| Phone |
9920116416 |
| Fax |
|
| Email |
nimish_wajekar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murlidhar Sastri |
| Designation |
MDS Professor and Post Graduate Guide |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
SMBT Staff Quarters SMBT Dental College and Hospital Amrutnagar Ghulewadi Sangamner
Department of Orthodontics and Dentofacial Orthopedics SMBT Dental College and Hospital Amrutnagar Ghulewadi Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9374727368 |
| Fax |
|
| Email |
drmurli24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimish Wajekar |
| Designation |
Post Graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
2C 701 Neel Park Near Sahasrabuddhe Hospital Swami Nityanand marg Old Panvel
Department of Orthodontics and Dentofacial Orthopedics SMBT Dental College and Hospital Amrutnagar Ghulewadi Sangamner
Ahmadnagar
MAHARASHTRA
410206
India |
| Phone |
9920116416 |
| Fax |
|
| Email |
nimish_wajekar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
SMBT Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics SMBT Dental College and Hospital Amrutnagar Ghulewadi Sangamner |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nimish Wajekar |
SMBT Dental College and Hospital |
204 3rd floor Dept. of Orthodontics and dentofacial orthopaedics, SMBT Dental College and Hospital Amrutnagar Ghulewadi Sangamner 422608 District Ahmednagar Maharashtra
Ahmadnagar
MAHARASHTRA |
9920116416
nimish_wajekar@yahoo.co.in |
|
|
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 |
| Patients |
Healthy Human Volunteers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acetaminophen (500 mg)
Ibuprofen (400 mg)
Ketorolac (10 mg)
|
single dose of all three drugs orally administered |
| Comparator Agent |
Placebo lactose capsule |
single dose of lactose capsule orally |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
16 years onwards |
|
| ExclusionCriteria |
| Details |
No systemic disease
No contraindication to use of NSAID
Currently not using antibiotics or analgesics
No prophylactic antibiotic coverage required
No teeth extracted at least two weeks before bonding
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| suppression of pain |
upto 6 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/03/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is a randomized, double blind, parallel group, trail comparing the efficacy of Acetaminophen 500mg , Ibuprofen 400mg and Ketorolac 10mg as single dose preoperative medication
for relieving orthodontic related pain after initial algining archwire placement that will be
conducted at SMBT Dental college and Hospital in India. The
primary outcome measures will be suppresion of pain upto 6 hour. |