| CTRI Number |
CTRI/2022/07/044144 [Registered on: 19/07/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing pain and anxiety after lignocaine and articaine administration under general anesthesia in children |
|
Scientific Title of Study
|
Evaluation of pain and anxiety using lignocaine and articaine in children undergoing full mouth rehabilitation under general anaesthesia: a randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palak Janiani |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, 162, Poonamalle High Road, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9820775554 |
| Fax |
|
| Email |
palakjaniani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Palak Janiani |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, 162, Poonamalle High Road, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9820775554 |
| Fax |
|
| Email |
palakjaniani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vignesh R |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, 162, Poonamalle High Road, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
vigneshr.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital, Chennai |
|
|
Primary Sponsor
|
| Name |
Palak Janiani |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital, 162, Poonamalle, Chennai, 600077 |
| 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 |
| Palak Janiani |
Saveetha Dental College & Hospital |
Clinic 28, Department of Pedodotnics, Saveetha Dental College, 162, Poonamalle High Road, Velappanchavadi, Chennai, Tamil Nadu,
Chennai
TAMIL NADU |
9820775554
palakjaniani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% Lignocaine |
2% lignocaine with vasoconstrictor (1:100000). Administered once intraoperatively and dose depends on weight of child. |
| Intervention |
Articaine |
4% Articaine with vasoconstrictor 1:20000) in carpule of Septodont brand. Administered once intraoperatively. Dose depends on weight of child. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
def/DMFT greater than 4
ASA classification of 1
Children indicated for treatment under general anesthesia
COVID-19 negative |
|
| ExclusionCriteria |
| Details |
Known allergy to lignocaine or articaine
Underlying systemic condition
Children with special needs
Any respiratory tract infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Salivary amylase levels |
Pre treatment
3 hours and 6 hours post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intra-operative vitals (Heart rate, end tidal carbon dioxide, SPO2) |
Intraoperatively during pulpectomy of lower molar during access opening, cleaning and shaping and obturation of tooth. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Most dental treatment should be carried out in the dental operatory under local anesthesia (LA). General anesthesia (GA) is used as an advanced type of behavior management technique to give quality dental care to children who are otherwise unable to endure dental treatment in an outpatient environment. Despite the widespread use of general anesthesia in pediatric dentistry, there are no established recommendations for using local anesthetics during these operations, except for the AAPD guidelines which simply mention that there is a postoperative pain reduction after administration of local anesthesia. |