| CTRI Number |
CTRI/2026/03/105173 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to See if Adding Dexmedetomidine to Local Anesthesia Improves Pain Control in Minor Oral and Jaw Surgeries |
|
Scientific Title of Study
|
Evaluation of the efficacy of Dexmedetomidine as an Adjuvant to Articaine in Minor Maxillofacial Surgical Procedures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Guntuboina Sree Varsha |
| Designation |
Postgraduate |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of Oral & maxillofacial surgery,
Room no.3
Sibar Institute of Dental Sciences, Takellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8985362612 |
| Fax |
|
| Email |
varsha.anandd14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Srinivas Chakravarthi |
| Designation |
Professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of Oral & maxillofacial surgery,
Room no.3
Sibar Institute of Dental Sciences, Takellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9392103703 |
| Fax |
|
| Email |
drsrinivaschakravarthisurgery@sids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
P Srinivas Chakravarthi |
| Designation |
Professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of Oral & maxillofacial surgery,
Room no.3
Sibar Institute of Dental Sciences, Takellapadu, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9392103703 |
| Fax |
|
| Email |
drsrinivaschakravarthisurgery@sids.ac.in |
|
|
Source of Monetary or Material Support
|
| SIBAR INSTITUTE OF DENTAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
GUNTUBOINA SREE VARSHA |
| Address |
Sibar Institute of Dental Sciences, Takellapadu, Guntur, Andhra Pradesh, 522509, 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 Guntuboina Sree Varsha |
SIBAR INSTITUTE OF DENTAL SCIENCES |
Department of Oral & maxillofacial surgery,Room No. 3
Guntur
ANDHRA PRADESH |
8985362612
varsha.anandd14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Sibar Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ARTICAINE MIXED WITH DEXMETEDOMIDINE |
There will be one group of sample consisting of 34 people who will receive local anesthesia of 4% articaine (5ml ) mixed with dexmetedomidine ( 1 mcg/kg b.wt) as a nerve block prior to treatment of minor maxillofacial surgical procedures who will be evaluated before, during & after procedure. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged from 20-45 years
2. ASA Physical Status I and II
3. Patients requiring minor oral and maxillofacial surgical procedures such as:
a. Open reduction & internal fixation of parasymphysis/symphysis/body/angle fractures (which can be operated under LA)
b. Small cysts and tumors (which can be operated under LA)
c. Other minor surgical procedures (which can be operated under LA)
Deeply impacted mandibular 3rd molars ( Position C – WHARFE Assessment)
Impacted canines
|
|
| ExclusionCriteria |
| Details |
1. Known allergy to articaine or dexmedetomidine
2. Pregnant or lactating women
3. Patients with bradycardia, hypotension, cardiac abnormalities
4. Patients not willing to provide written informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical outcome – Pain
hemodynamic parameters (heart rate, blood pressure, O2 saturation
Anxiety
Sedation
Onset & duration of anesthesia
|
15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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
|
This prospective clinical study aims to evaluate the effectiveness of adding dexmedetomidine to 4% articaine in patients undergoing minor oral and maxillofacial surgical procedures under local anesthesia. A total of 34 patients (ASA I and II) aged 20–45 years will be included and allocated to receive articaine with dexmedetomidine. The study will assess onset and duration of anesthesia, intraoperative pain using the Visual Analog Scale (VAS), hemodynamic parameters (heart rate, blood pressure, and oxygen saturation), sedation level, and time to first rescue analgesic. The objective is to determine whether dexmedetomidine improves anesthetic efficacy, prolongs analgesia, and maintains hemodynamic stability compared to conventional local anesthesia, thereby enhancing patient comfort and surgical outcomes. |