| CTRI Number |
CTRI/2021/03/031703 [Registered on: 04/03/2021] Trial Registered Prospectively |
| Last Modified On: |
03/06/2021 |
| 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 equally effective to lignocaine for removal of loose tooth? |
|
Scientific Title of Study
|
Effectiveness of tramadol compared to lignocaine as a local anesthesia in extraction of mobile tooth- a randomized equivalence trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manu Goel |
| Designation |
Associate Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital,Nagpur |
| Address |
Department of Oral and Maxillofacial Surgery,
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital,
Nagpur
MAHARASHTRA
441 110
India |
| Phone |
09011794068 |
| Fax |
|
| Email |
mrimanster@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manu Goel |
| Designation |
Associate Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital,Nagpur |
| Address |
Department of Oral and Maxillofacial Surgery,
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital,
Nagpur
MAHARASHTRA
441 110
India |
| Phone |
09011794068 |
| Fax |
|
| Email |
mrimanster@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manu Goel |
| Designation |
Associate Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital,Nagpur |
| Address |
Department of Oral and Maxillofacial Surgery,
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital,
Nagpur
MAHARASHTRA
441 110
India |
| Phone |
09011794068 |
| Fax |
|
| Email |
mrimanster@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Manu Goel |
| Address |
Department of Oral and Maxillofacial Surgery
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital
Nagpur
MAHARASHTRA
441 110
India |
| 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 |
| Manu Goel |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
Department of Oral and Maxillofacial Surgery
Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital
Nagpur
MAHARASHTRA
441 110
India
Nagpur
MAHARASHTRA |
09011794068
mrimanster@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDKS dental college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K040||Pulpitis. Ayurveda Condition: Loose tooth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1.8 ml of 2% Lignocaine |
1.8 ml of 2% Lignocaine without vasocontrictor is infiltrated supraperiosteally and signs and symptoms of anesthesia are checked. Excessive amount (0.6 ml) of same drug is injected in necessary cases where one injection was not sufficient for achieving anesthesia. Duration of therapy was from injecting the drug till the completion of tooth extraction process. |
| Intervention |
1.8 ml of 5% Tramadol |
1.8 ml of 5% Tramadol without vasocontrictor is infiltrated supraperiosteally and signs and symptoms of anesthesia are checked. Excessive amount (0.6 ml) of same drug is injected in necessary cases where one injection was not sufficient for achieving anesthesia. Duration of therapy was from injecting the drug till the completion of tooth extraction process. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Firm but Grossly decayed maxillary first molars.
2.Firm Root pieces with maxillary first molars. |
|
| ExclusionCriteria |
| Details |
1)Medically compromised individuals.
2)pregnant or lactating females.
3)those who were allergic to the drugs used in the trial.
4)Patients not willing to consent for the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intra operative pain |
at baseline, the point of time when patient feels pain during the entire extraction procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amount of solution used as anesthetic agent |
total amount will be calculated after the the completion of extraction procedure |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
05/03/2021 |
| 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="0"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized double blind equivalence trial comparing the efficiency of Tramadol versus Lignocaine as local anesthetic for dental extraction of mobile maxillary first molars 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 amount of anesthetic agent used for completion of extraction. |