| CTRI Number |
CTRI/2023/06/054370 [Registered on: 23/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative research on the effectiveness of dexmedetomidine and local anesthesia for surgically extracting mandibular third molars |
|
Scientific Title of Study
|
Efficacy of dexmedetomidine with local anaesthesia for surgical removal of mandibular third molars; a comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Heena Khan |
| Designation |
Postgraduate student |
| Affiliation |
Yenepoya Dental College |
| Address |
Yenepoya Dental College, Department of Oral and Maxillofacial Surgery, First floor,University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7303715994 |
| Fax |
|
| Email |
drheenakhanx@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joyce P Sequiera |
| Designation |
Senior Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Dept of Oral and Maxillofacial surgery, Yenepoya Dental College,
University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448337826 |
| Fax |
|
| Email |
joycemathias26@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heena Khan |
| Designation |
Postgraduate student |
| Affiliation |
Yenepoya Dental College |
| Address |
Dept of Oral and Maxillofacial Surgery, Yenepoya Dental College,
University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7303715994 |
| Fax |
|
| Email |
drheenakhanx@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Dental College Yenepoya (Deemed to be University),
University Road Deralakatte Mangalore
575018, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Heena Khan |
| Address |
Yenepoya Dental College, Department of Oral and Maxillofacial Surgery, Yenepoya (Deemed to be University),
University Road, Deralakatte, Mangalore
575018, Karnataka |
| Type of Sponsor |
Other [self funded] |
|
|
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 Heena Khan |
Yenepoya Dental College |
Yenepoya (Deemed to be University) University Road Deralakatte Mangalore 575018
Dakshina Kannada
KARNATAKA |
7303715994
drheenakhanx@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bilateral impacted tooth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% Lignocaine with 1:200000 adrenaline |
The selected patients will be administered dexmedetomidine in combination with lignocaine 2% as an adjuvant with 1:200,000 adrenaline on right side and lignocaine 2% with 1: 200,000 adrenaline on the left side within a month. |
| Intervention |
2% Lignocaine with 1:200000 adrenaline and dexmedetomidine |
The selected patients will be administered dexmedetomidine in combination with lignocaine 2% as an adjuvant with 1:200,000 adrenaline on right side and lignocaine 2% with 1: 200,000 adrenaline on the left side within a month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA class I patient
2.Age group18-40 years
3.Bilateral similar impaction (with same classification and difficulty index)
|
|
| ExclusionCriteria |
| Details |
1.Patients with a known history of an allergy or hypersensitivity to lignocaine or dexmedetomidine,
2.Pregnant or lactating mothers
3.Patients with acute pericoronitis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Faster onset of local anaesthesia, prolonged duration of local anaesthesia, decrease in bleeding intraoperatively |
One and half year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better hemodynamic stability |
Two weeks |
| Faster action of onset |
Once LA is injected (2-3 minutes) |
| Prolong duration of anaesthesia |
Assessed from injecting LA to when the effect is weaned of (usually 2-3 hours) |
| Decrease in bleeding |
Assessed after surgical extraction immediately |
| Patient experience |
Post operatively 1 - 2 hours |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain is one of the most important
complications in the extraction of teeth which can even cause the patients not willing to seek
further dental treatment. Becoming aware of the need for a surgery evokes
feelings of fear and anxiety in many patients. Dexmedetomidine
is a selective alpha‑2 adrenoceptor agonist. It is conventionally used as a
sedative in the intensive care unit.
However, recently, the application of dexmedetomidine as an adjuvant
to a local anesthetic agent has been studied. The present study intends to
evaluate the effectiveness of dexmedetomidine as an adjuvant to 2% lignocaine
with adrenaline for surgical removal of impacted mandibular third molar.
A total of 15 patients who require surgical removal of impacted
mandibular third molar extraction will be included in the study. Patients in
the study group will receive 2%
lignocaine and adrenaline with 1 mcg/ml dexmedetomidine. Patients in
the control group will receive 2% lignocaine with 1:200000 adrenaline. The
parameters for evaluation will be onset and duration of action, pulse rate,
blood pressure, oxygen saturation, and blood loss along with patient
satisfaction score. |