| CTRI Number |
CTRI/2025/06/089879 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of two local anesthesia drugs immediately after injection |
|
Scientific Title of Study
|
Comparative evaluation of adrenaline and dexmedetomidine as adjunct with lignocaine in enhancing local anesthesia: A split-mouth crossover 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 |
Dr S Vittal Sai |
| Designation |
Postgraduate |
| Affiliation |
AMEs dental college hospital and research center |
| Address |
Room No 4, Department of pedodontics and preventive dentistry, AMEs dental college hospital and research center, Raichur, Karnataka, India
Raichur
KARNATAKA
584103
India |
| Phone |
9490447400 |
| Fax |
|
| Email |
kanchantuppadmath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrutha S P |
| Designation |
Professor |
| Affiliation |
AMEs dental college hospital and research center |
| Address |
Room No 4, Department of pedodontics and preventive dentistry, AMEs dental college hospital and research center, Raichur, Karnataka, India
Raichur
KARNATAKA
584103
India |
| Phone |
9483329406 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrutha S P |
| Designation |
Professor |
| Affiliation |
AMEs dental college hospital and research center |
| Address |
Room No 4, Department of pedodontics and preventive dentistry, AMEs dental college hospital and research center, Raichur, Karnataka, India
KARNATAKA
584103
India |
| Phone |
9483329406 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. S Vittal sai |
| Address |
Room No 4 AMEs dental college hospital and research center, Near Govt. Polytechnic college, Bijengera road Raichur, Karnataka |
| 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 S Vittal Sai |
AMEs dental college hospital and research center |
Room No 4, Department of pedodontics and preventive dentistry, AMEs dental college hospital and research center, Raichur, Karnataka, India
Raichur
KARNATAKA |
9490447400
vittal4dv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee for AMEs dental college hospital and research center, raichur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
adrenaline |
2% lignocaine 1:80,000 of adrenaline as an adjunct in local anesthesia |
| Intervention |
Dexmedetomidine |
1mcg of dexmedetomidine/1ml of 2% lignocaine as an adjunct in local anesthesia |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 6-14years,
Children with American Society of Anesthesiologists (ASA) grade I status,
Children who require multiple appointments for treatment under local anesthesia as infiltration/block bilaterally.
|
|
| ExclusionCriteria |
| Details |
Children who are allergic to local anesthetic solution,
Children with local infection, abscess and pus discharge,
Children who are medically compromised and special children,
Children who are not willing and whose parents declined to sign informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexmedetomidine is superior as adjunct with lignocaine compared with lignocaine and adrenaline in onset of action and depth of anesthesia |
immediately after local anesthesia administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
05/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 compares and evaluate the efficacy of adrenaline and dexmedetomidine as lignocaine adjunct in enhancing local anesthesia in children. This study is triple blind parallel arm randomized controlled trail and includes total of 40 samples allocated 20 samples for each group by computerized randomization. 2% Lignocaine with adrenaline 1:80,000 will be control group and 2% Lignocaine with dexmedetomidine titrated as 1ml/1mcg. Ethical clearance is obtained from institutional ethical committee before starting study. Informed/ proxy consent is taken from parent/guardian. Local anesthesia is administered with protocol by trained professional based on inclusion criteria. Pain will be assessed with visual analogue scale. |