| CTRI Number |
CTRI/2025/02/080772 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative assessment of dexmedetomidine (analgesic and sedative drug) as a contributory agent to 2 percent plain lignocaine and 2 percent lignocaine with 1:200,000 adrenaline (drug to increase anesthesia time) as local anesthetic agents for removal of impacted lower 3rd molar |
|
Scientific Title of Study
|
Comparative evaluation of Dexmedetomidine as an adjuvant to 2 percent plain lignocaine and 2 percent lignocaine with 1:200,000 adrenaline as local anesthetic agents for surgical removal of impacted mandibular third molars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanishka Tyagi |
| Designation |
1st year junior resident |
| Affiliation |
subharti dental college and hospital |
| Address |
subharti dental college and hospital, subharti University meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09456553100 |
| Fax |
|
| Email |
tyagikanishka10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanishka Tyagi |
| Designation |
1st year junior resident |
| Affiliation |
subharti dental college and hospital |
| Address |
subharti dental college and hospital, subharti University meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09456553100 |
| Fax |
|
| Email |
tyagikanishka10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanishka Tyagi |
| Designation |
1st year junior resident |
| Affiliation |
subharti dental college and hospital |
| Address |
subharti dental college and hospital, subharti University meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09456553100 |
| Fax |
|
| Email |
tyagikanishka10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti Dental College And Hospital, Meerut, Uttar pradesh,India pin 250005 |
|
|
Primary Sponsor
|
| Name |
subharti dental college |
| Address |
Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh 250005 |
| Type of Sponsor |
Other [private dental college ] |
|
|
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 kanishka tyagi |
subharti dental college and hospital |
Subharti dental college and hospital, Department of oral and maxillofacial surgery, room no. 5, subharti University meerut,
Meerut
UTTAR PRADESH |
09456553100
tyagikanishka10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE(MEDICAL) SWAMI VIVEKANAND SUBHARTI UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% lignocaine with 1:200000 adrenaline |
Lignocaine with adrenaline prolongs the duration as well as the depth of anesthesia and prevent or minimize the blood loss during surgical procedures by vaso-constrictive properties |
| Intervention |
Dexmedetomidine WITH 2% plain lignocaine |
Dexmedetomidine is a selective alpha 2 agonist used in anesthesia. When used with lignocaine it can enhance analgesia, prolong duration of action and improve hemodynamic stabiity |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
patients with ASA 1 status
patients with presence of impacted lower 3rd molar indicated for extraction. |
|
| ExclusionCriteria |
| Details |
-Participants with a history of drug abuse and alcohol intoxication
-Patients with Immunocompromised status.
-Patients with comorbidities such as hypertension and diabetes
-Presence of any local infection,
-Women on oral contraceptives or pregnant and nursing mothers
-Patients allergic to the LA used in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| onset and duration of LA, hemodynamic stability by recording pulse rate, blood pressure and spo2 at different intervals of time and anti-inflammatory action by measuring mouth opening and facial swelling at 24-48-hour, 48-72-hour, and 1-week follow-up period |
baseline- pre operative,
postoperative - 24hrs- 48 hrs
post operative -48hrs to 72 hrs
post operative- 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mouth opening/ VAS score after 3 days post operative |
3 days post operative |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="1"
Months="5"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tyagikanishka10@gmail.com].
- For how long will this data be available start date provided 28-01-2025 and end date provided 28-07-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
There has always been a constant search for more potent, effective,
and better-handling local anaesthetic drugs and adjuvants in the field of
anaesthesia. The purpose of this study is to compare the two
adjuvants to lignocaine based on their properties of improving the time of
onset of anesthesia, the duration of anesthesia, reducing surgical blood field,
their effects on basic vitals of the body and if they possess any significant anti-inflammatory
actions. Dexmedetomidine (DEX),
an extensively selective alpha-2 receptor agonist, is progressively utilized in
the perioperative phase, eliciting sedation, analgesia, anxiolysis, and
inhibition of sympathetic tone. Lignocaine with adrenaline
prolongs the duration as well as the depth of
anesthesia and prevent or minimize the blood loss during surgical procedures by
vaso-constrictive properties. This study compares the effects of 2% lignocaine with 1:200000 adrenaline to the
combination of dexmedetomidine and 2% plain lignocaine injected for the
inferior alveolar nerve and long buccal nerve block in patients undergoing
surgical removal of an impacted mandibular third molar. |