| CTRI Number |
CTRI/2020/02/023093 [Registered on: 03/02/2020] Trial Registered Prospectively |
| Last Modified On: |
04/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the numbness effect of 0.75% ropivacaine and 0.5% bupivacaine in surgical removal of wisdom tooth of lower jaw |
|
Scientific Title of Study
|
A double blind randomized study to evaluate and compare the anaesthetic efficacy of 0.75% Ropivacaine and 0.5% Bupivacaine on the perioperative regional analgesia in impacted mandibular third molar surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Mishra |
| Designation |
Resident |
| Affiliation |
Peoples Dental Academy |
| Address |
Room No 101
Department of Oral and Maxillofacial Surgery
Peoples Dental Academy
Bhopal , MP
Bhopal
MADHYA PRADESH
462010
India |
| Phone |
9009013215 |
| Fax |
|
| Email |
nishamishra838@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Sharma |
| Designation |
Professor |
| Affiliation |
Peoples Dental Academy |
| Address |
Room No 101
Department of Oral and Maxillofacial Surgery
Peoples Dental Academy
Bhopal , MP
Bhopal
MADHYA PRADESH
462010
India |
| Phone |
9826048261 |
| Fax |
|
| Email |
sharma.dryogesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Sharma |
| Designation |
Professor |
| Affiliation |
Peoples Dental Academy |
| Address |
Room No 101
Department of Oral and Maxillofacial Surgery
Peoples Dental Academy
Bhopal , MP
Bhopal
MADHYA PRADESH
462010
India |
| Phone |
9826048261 |
| Fax |
|
| Email |
sharma.dryogesh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nisha Mishra |
| Address |
Room No 101
Department of Oral and Maxillofacial Surgery
Peoples Dental Academy
Bhopal , MP |
| 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 |
| Nisha Mishra |
Peoples Dental Academy |
Room No 101
Department of Oral and Maxillofacial Surgery
Peoples Dental Academy
Bhopal , MP
Bhopal
MADHYA PRADESH |
9009013215
nishamishra838@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples Dental Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q899||Congenital malformation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
Bupivacaine 0.5%
Dose- 1.5- 2ml
Frequency- Once
Route of Administration- Intra-Oral Infiltration and Nerve Block
Duration of anesthesia- 4-5 hours |
| Intervention |
Ropivacaine |
Ropivacaine 0.75%
Dose- 1.5- 2ml
Frequency- Once
Route of Administration- Intra-Oral Infiltration and Nerve Block
Duration of anesthesia- 4-5 hours
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Impacted Mandibular 3rd molar
|
|
| ExclusionCriteria |
| Details |
Allergic to any of the local anaesthetic solution
Pregnant Women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset of Local Anaesthesthetic solution
|
15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of Local Anaesthetic solution |
1 hour |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2020 |
| Date of Study Completion (India) |
14/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The results obtained from this study revealed interesting applications in both clinical and future research on the topic. This study summarizes the unbiased direct comparison of 0.75% ropivacaine and 0.5% bupivacaine. From the results and discussion, this study states that ropivacaine provides a successful and higher rate of local conduction anaesthesia than bupivacaine local anaesthetic solution by providing- the faster onset of anaesthesia, greater depth of anaesthesia, greater duration of anaesthesia, lesser intraoperative pain and lesser intraoperative bleeding. In a comparison of the use of 0.75% ropivacaine and 0.5% bupivacaine local anaesthetic solutions in healthy patients, it could be hypothetically stated that 0.5% bupivacaine could result in mild cardiovascular problems. Hence to conclude the following results of our study, the magnitude of perioperative pain reduction during the surgery of the lower wisdom tooth is comprehended through the local long-lasting anaesthetic 0.75% ropivacaine, over 2 mL 0.5% bupivacaine. Ropivacaine is better than bupivacaine in the management of pain with no such cardiovascular problems and can be used in regular dental practice. |