| CTRI Number |
CTRI/2019/12/022333 [Registered on: 12/12/2019] Trial Registered Prospectively |
| Last Modified On: |
10/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Is tramadol an alternative to lignocaine for removal of tooth? |
|
Scientific Title of Study
|
Is tramadol an effective alternative to lignocaine in pain control for simple extraction? A split mouth double blind randomized 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 |
Dr Manu Goel |
| Designation |
Reader and Guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
| Address |
Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9011794068 |
| Fax |
|
| Email |
mrimanster@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Goel |
| Designation |
Reader and Guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
| Address |
Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9011794068 |
| Fax |
|
| Email |
mrimanster@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu Goel |
| Designation |
Reader and Guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
| Address |
Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9011794068 |
| Fax |
|
| Email |
mrimanster@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Manu Goel |
| Address |
Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur |
| 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 Manu Goel |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongri, Nagpur
Nagpur
MAHARASHTRA |
9011794068
mrimanster@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine |
1 ml of 2% lignocaine with adrenaline concentration 1:80000 |
| Intervention |
Tramadol |
50mg tramadol (1ml Ampule) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Grossly decayed maxillary molars.
2. Root pieces with maxillary molars.
3. Over retained deciduous teeth
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised patient
2. Tooth with periapical infection
3. RC treated tooth
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anesthetic Efficiency |
Till the completion of the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia |
12 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/12/2019 |
| Date of Study Completion (India) |
17/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/01/2020 |
|
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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Split mouth randomized, double blind Study comparing the efficiency of 50mg Tramadol versus 2% Lignocaine as local anesthetic for dental extraction that will be conducted in Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Nagpur. The primary outcome measure will be anesthetic efficiency of tramadol over lignocaine in extraction of maxillary molars. The secondary outcome will be the time for which post operative analgesia was effective after extraction of teeth. Patients will be recalled after 12 hours for follow up. |