| CTRI Number |
CTRI/2025/01/079179 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Tramadol hydrochloride local infilteration and lignocaine hydrochloride local infilteration in anterior maxillary region to find out which anesthesing has less pain score while extracting teeth. |
|
Scientific Title of Study
|
Tramadol hydrochloride vs lignocaine hydrochloride in the extraction of anterior teeth - comparative study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srishti Agarwal |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college and hospital |
| Address |
57/3 M.M. Feeder road , clubtown residency bl-2/3c, Rathtala
Clinic 20 , department of oral and maxillofacial surgery,
162, poonamallee high road, vellapanchavadi, chennai - 600077
Chennai
TAMIL NADU
700056
India |
| Phone |
9874516410 |
| Fax |
|
| Email |
Srishti160@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saravanan Lakshmanan |
| Designation |
Reader ( Associate Professor) |
| Affiliation |
Saveetha dental college and hospital |
| Address |
Department of oral and maxillofacial surgery,
Saveetha dental college and hospital,
162, poonamallee high road, vellapanchavadi, chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9874516410 |
| Fax |
|
| Email |
Sivachandru93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srishti Agarwal |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college and hospital |
| Address |
Clinic 20,
Department of oral and maxillofacial surgery,
162, poonamallee high road, vellapanchavadi, chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9874516410 |
| Fax |
|
| Email |
Srishti160@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospital
162, poonamallee high road, vellapanchavadi, chennai - 600077 |
|
|
Primary Sponsor
|
| Name |
Srishti Agarwal |
| Address |
Saveetha dental college and hospital
162, Poonamallee high road, vellapanchavadi, chennai- 600077 |
| 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 |
| Srishti Agarwal |
Saveetha dental college and hospital |
Clinic 20,
Department of oral and maxillofacial surgery,
162, poonamallee high road, vellapanchavadi , chennai - 600077
Thiruvallur
TAMIL NADU |
09874516410
Srishti160@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha ethical clearance committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Compromised maxillary anterior teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% lignocaine hydrochloride |
To compare tramadol with gold standard local anesthesia - lignocaine as a local anesthetic agent given as an infilteration at the time of extraction. |
| Intervention |
5% Tramadol hydrochloride |
To evaluate the efficacy of tramadol as local anesthetic agent given as an infilteration at the time of extraction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring extraction of one or more maxillary anterior teeth and providing informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with known allergies to lignocaine or tramadol, those with significant medical conditions contraindicating dental extractions, pregnant or lactating women, and patients on medications that could interfere with pain perception or local anesthesia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain with VAS score |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset of anesthesia in minutes |
At baseline |
| Amount of anesthesia administered in number of vials |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
19/02/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background
The aim of this study was to compare the local anesthetic effect of tramadol with that of lignocaine in the extraction of maxillary anterior teeth.
CLINICAL RELEVANCE
Scientific rationale for the study: The study emphasizes the necessity of choosing the right local anesthetic to ensure adequate pain relief during dental treatments. Principal findings: We found that tramadol can also be used as an anesthetic agent. Although it is not as potent as lignocaine, a higher quantity of tramadol is required to obtain the desired amount of anesthesia, and has a faster onset of action.
Practical implications: Lignocaine is still the gold standard because of its superior efficacy and safety profile. Tramadol, on the other hand, may have importance in some situations , such as in patients who are allergic to lignocaine or other conventional local anesthetics. In such circumstances, tramadol could be administered as an adjuvant to improve the overall anesthetic effect, although greater dosages may be required to achieve effective pain management.
|