| CTRI Number |
CTRI/2024/07/070401 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Tramadol, Ropivacaine, Lignocaine and Articaine in
Patients undergoing Removal of Maxillary Posterior
Tooth : To Compare Differences in Anesthetic action, Pain
management, and Adverse effects |
|
Scientific Title of Study
|
Comparative evaluation of 50mg Tramadol, 0.75 Percent
Ropivacaine, 2 Percent Lignocaine and 4 Percent Articaine in
Patients undergoing Extraction of Maxillary Posterior
Tooth: Unveiling Differences in Anesthetic Action, Pain
Management, and Adverse Effects – A Double Blinded
Randomized Clinical Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Akash |
| Designation |
Post Graduate Student |
| Affiliation |
Thai Moogambigai Dental college and hospital Unit of DR. M.G.R Educational and Research institute |
| Address |
Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital,
DR. M.G.R Educational and Research institute
Golden George Nagar
Mugappair
Tamil Nadu India
Thiruvallur
TAMIL NADU
600107
India |
| Phone |
9677188145 |
| Fax |
|
| Email |
akashns2295@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Gayathri |
| Designation |
Professor |
| Affiliation |
Thai Moogambigai Dental college and hospital Unit of DR. M.G.R Educational and Research institute |
| Address |
Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital
DR. M.G.R Educational and Research institute
Golden George Nagar
Mugappair
Tamil Nadu India
Thiruvallur
TAMIL NADU
600107
India |
| Phone |
9841697444 |
| Fax |
|
| Email |
drgayathri20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Gayathri |
| Designation |
Professor |
| Affiliation |
Thai Moogambigai Dental college and hospital Unit of DR. M.G.R Educational and Research institute |
| Address |
Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital
DR. M.G.R Educational and Research institute
Golden George Nagar
Mugappair
Tamil Nadu India
Thiruvallur
TAMIL NADU
600107
India |
| Phone |
9841697444 |
| Fax |
|
| Email |
drgayathri20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital
DR. M.G.R Educational and Research institute
Golden George Nagar
Mugappair
Tamil Nadu India
|
|
|
Primary Sponsor
|
| Name |
Dr N Akash |
| Address |
Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital
DR. M.G.R Educational and Research institute
Golden George Nagar
Mugappair
Tamil Nadu 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 |
| Dr N Akash |
Thai Moogambigai Dental College and Hospital |
Branch 3, Department of Oral and Maxillofacial surgery, Thai Moogambigai Dental college and hospital,
DR. M.G.R Educational and Research institute
Golden George Nagar
Mugappair
Tamil Nadu
India
Thiruvallur
TAMIL NADU |
9677188145
akashns2295@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE OF THAI MOOGAMBIGAI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.75% Ropivacaine |
Using 0.75% Ropivacaine in Patients undergoing Extraction of Maxillary Posterior Tooth: Unveiling Differences in Anesthetic Action, Pain Management, and Adverse Effects |
| Comparator Agent |
2% Lignocaine Hydrochloride |
Using 2% Lignocaine Hydrochloride in Patients undergoing Extraction of Maxillary Posterior Tooth: Unveiling Differences in Anesthetic Action, Pain Management, and Adverse Effects |
| Intervention |
4% Articaine |
Using 4% Articaine in Patients undergoing Extraction of Maxillary Posterior Tooth: Unveiling Differences in Anesthetic Action, Pain Management, and Adverse Effects |
| Intervention |
50mg Tramadol |
Using 50mg Tramadol in Patients undergoing Extraction of Maxillary Posterior Tooth: Unveiling Differences in Anesthetic Action, Pain Management, and Adverse Effects |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients both males and females aged 20–70 years.
2-Firm tooth requiring extraction.
3-Patients indicated for extraction of maxillary posterior tooth.
4-ASA -I and II physical status patients.
5-Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1-Pregnant or lactating females.
2-Patients with a history of drug allergy.
3-Patients presenting with any systemic diseases.
4-Patients with recent history of infection for which medications were taken.
5-Mobile tooth.
6-Tooth or root stumps with periapical lesions and abscesses.
7-RCT – Treated tooth requiring transalveolar extraction or with secondary infection.
8-Deleterious personal habits.
9-Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the - Anesthetic action the onset of anesthesia and duration, The amount of anesthetic solution, Pain Management and Hemodynamic changes |
Time duration of anaesthetic action will be measured after giving local anesthesia till the end of extraction procedure.
Pain management and Hemodynamic changes will be measured Pre operatively after 10 minutes giving local anesthesia.
Intra operatively during the procedure.
Post operatively after completion of tooth extraction till 10 minutes on the same day of extraction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the adverse effects of local anesthetics. |
Time points are measured Pre operatively after 10 minutes giving local anesthesia.
Intra operatively during the extraction procedure.
Post operatively after completion of tooth extraction till 10 minutes on the same day of extraction. |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/07/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Comparative evaluation of 50mg Tramadol, 0.75% Ropivacaine, Lignocaine Hydrochloride and 4% Articaine based on their success rates, amount of local anaesthetic agent delivered, onset, duration of action, Pre-operative, intra-operative pain and Post-operative pain and intensity, hemodynamic changes and adverse effects during maxillary tooth extraction. Methodology This study includes a total of 220 patients. The sample size will be 55 patients per group. Group A: Each patient will receive an initial dose of 1 dental syringe (1.8 mL) of drug A mixture of Tramadol HCl 50 mg. Group B: Each patient will receive an initial dose of 1 dental syringe (1.8 mL) of drug A mixture of 0.75% Ropivacaine. Group C: Each patient will receive an initial dose of 1 dental syringe (1.8 mL) of drug A mixture of 2% Lignocaine Hydrochloride. Group D: Each patient will receive an initial dose of 1 dental syringe (1.8 mL) of drug A mixture of 4% Articaine. The intra alveolar extraction procedure will be performed in all patients. The following parameters to be assessed pre operatively, intra procedure and post operatively are: 1. Amount of solution. 2. Onset and duration of action. 3. Pain 4. Sensory innervations. 5. Vitals. 6. Adverse effects. Benefits of the Study : To wisely choose the right choice and dosage of drug for extraction of maxillary posterior tooth.
|