| CTRI Number |
CTRI/2026/01/101174 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Adrenaline, Clonidine, and Dexmedetomidine in Enhancing Local Anesthesia for Orthodontic Extractions Using the Infraorbital Block. |
|
Scientific Title of Study
|
Comparing the Effectiveness of Adrenaline, Clonidine, and Dexmedetomidine in Enhancing Local Anesthesia for Orthodontic Extractions Using the Infraorbital Block: A Randomized 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 |
Venus Kale |
| Designation |
Intern |
| Affiliation |
Ranjeet Deshmukh Dental college and Research centre |
| Address |
02, Department of Oral and Maxillofacial Surgery, Ranjeet Deshmukh dental college and Research centre, Digdoh hills, Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9075781976 |
| Fax |
|
| Email |
venuskale2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vrinda Kolte |
| Designation |
Professor |
| Affiliation |
Ranjeet Deshmukh Dental college and Research centre |
| Address |
02, Department of Oral and Maxillofacial Surgery, Ranjeet Deshmukh dental college and Research centre, Digdoh hills, Nagpur. 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822366938 |
| Fax |
|
| Email |
drvrindkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vrinda Kolte |
| Designation |
Professor |
| Affiliation |
Ranjeet Deshmukh Dental college and Research centre |
| Address |
02, Department of Oral and Maxillofacial Surgery, Ranjeet Deshmukh dental college and Research centre, Digdoh hills, Nagpur. 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822366938 |
| Fax |
|
| Email |
drvrindkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental college and Research Centre,Digdoh hills, Hingna road, Nagpur 440019 |
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh dental college and research centre, nagpur |
| Address |
02, Department of Oral and Maxillofacial surgery, Ranjeet Deshmukh Dental college and research centre, Digdoh Hills, Nagpur 440019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Venus Kale |
Ranjeet Deshmukh dental college and Research Centre |
02, Department of Oral and Maxillofacial Surgery, Ranjeet Deshmukh Dental college and Research Centre, Digdoh hills, Nagpur 440019
Nagpur
MAHARASHTRA |
9075781976
venuskale2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Indicated for patients undergoing Maxillary Orthodontic Extraction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2% Lignocaine Hydrochloride with 1 microgram / ml Dexmedetomidine |
Dexmedetomidine, known for its sedative and analgesic properties, is also emerging as a promising adjunct in local anesthesia. |
| Intervention |
2% Lignocaine Hydrochloride with 15 microgram / ml Clonidine |
Clonidine is an alpha-2 adrenergic agonist that has shown to improve local anaesthesia by affecting the sympathetic nervous system and reducing pain perception. |
| Comparator Agent |
2% Lignocaine Hydrochloride with 1:200,000 Adrenaline |
Adrenaline, a vasoconstrictor, prolongs anesthesia and reduces bleeding. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient requiring extraction of Maxillary premolar.
2. Patients over age of 15 years, both male and female will be included in this study.
3. Systemically healthy patients.
4.Co-operative, motivated and hygiene conscious patients. |
|
| ExclusionCriteria |
| Details |
1) Pregnant or lactating females.
2) Patient with periapical infection in maxillary premolars.
3) Allergy to any local anaesthetic agent and anti-inflammatory drugs.
4) Patients with high-risk systemic diseases.
5) Those who deny for consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcomes of this study will include the onset time, duration of anaesthesia, pain perception during the orthodontic extraction procedure, postoperative pain, analgesic consumption, patient satisfaction, and any adverse effects, to evaluate the efficacy and safety of adrenaline, clonidine, and dexmedetomidine as adjuvants to lignocaine in infraorbital nerve blocks. |
Outcome variables were assessed at predetermined time points, including onset of anaesthesia (30 seconds to 5 minutes post-block), duration of anaesthesia (until return of sensation), intraoperative pain during extraction, postoperative pain at 1, 2, 4, 6, 12, and 24 hours, analgesic consumption within 24 hours, patient satisfaction at 24 hours, and adverse effects monitored immediately, within 2 hours, and at 24 hours post-procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
26/01/2026 |
| 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="0"
Months="3"
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 study is a double-blinded randomized controlled trial comparing adrenaline, clonidine, and dexmedetomidine as adjuvants to 2% lignocaine for infraorbital nerve block in orthodontically indicated maxillary premolar extractions. The primary outcomes assessed include onset, duration, and depth of anesthesia, intra-operative pain, postoperative pain, and need for additional analgesia, along with patient satisfaction and adverse effects. A total of 66 patients (22 per group), aged above 15 years and systemically healthy, will be selected from the Oral & Maxillofacial Surgery OPD and randomly allocated into three study groups. Standardized infraorbital block administration will be followed, and outcomes will be measured using stopwatch timing and VAS/Wong-Baker pain scales. Data will be analyzed using ANOVA and Tukey’s post-hoc test for normal variables and the Kruskal-Wallis test for ordinal or non-normal data, with significance set at p < 0.05. The planned study duration is approximately three months. |