| CTRI Number |
CTRI/2024/03/064277 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of 4% Articaine as local anaesthetic agent in pediatric dentistry |
|
Scientific Title of Study
|
Comparative Evaluation Of Onset Of Action And Efficacy Of 2% Lignocaine And 4% Articaine After Administration Of Local Anaesthesia For Pulp Therapy Of Primary Maxillary Molars In Children Aged 5-10 Years : A Randomized Clinical 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 Sanika Karmarkar |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Pediatric and Preventive Dentistry, KLE VK Institute of dental sciences, Belgaum |
| Address |
KLE VK Institute of Dental Sciences, JNMC campus Nehru nagar
Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9920896106 |
| Fax |
|
| Email |
sanikakarmarkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar M Badakar |
| Designation |
Professor |
| Affiliation |
Department of Pediatric and Preventive Dentistry, KLE VK Institute of dental sciences, Belgaum |
| Address |
JNMC campus Nehru nagar
Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9902773259 |
| Fax |
|
| Email |
badakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanika Karmarkar |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Pediatric and Preventive Dentistry, KLE VK Institute of dental sciences, Belgaum |
| Address |
JNMC campus Nehru nagar
Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9920896106 |
| Fax |
|
| Email |
sanikakarmarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sanika Karmarkar, Department of Pediatric and Preventive Dentistry, KLE VK Institute of Dental Sciences. |
|
|
Primary Sponsor
|
| Name |
Dr Sanika Karmarkar |
| Address |
KLE VK Institute of dental sciences, Belagavi |
| 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 Sanika Karmarkar |
KLE VK Institute of Dental Sciences |
Department of Pediatric and Preventive Dentistry, Department number 6, 1st floor, KLE VK Institute of dental sciences, JNMC campus, Nehru nagar,
Belgaum, Karnataka
Belgaum
KARNATAKA |
9920896106
sanikakarmarkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2% Lignocaine |
Local anaesthetic agent. Dosage: 1 ml (maximum permissible dose of 7 mg/kg) given as injection intraorally once before treatment |
| Comparator Agent |
4% Articaine |
Local anaesthetic agent. Dosage: 1 ml (maximum permissible dose of 7 mg/kg) given as injection intraorally once before treatment |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients with maxillary molars requiring pulpectomy treatment |
|
| ExclusionCriteria |
| Details |
Medically compromised patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset of action of Articaine 4% and Lignocaine 2%(recorded in seconds) |
Time will be recorded only once after administration of local anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Articaine 4% & Lignocaine 2% |
Measured after access opening of the tooth anaesthetized (once) |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 4 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
48 patients, between the ages of 5 to 10 years, requiring pulpectomy treatment for maxillary molars will be recruited for the study. The patients will be randomized into 2 groups, Group A will receive 2% Lignocaine and Group B will receive 4% Articaine as local anaesthetic agents. A skin prick allergy test will be done prior to injection. After a negative test, the child will undergo local anaesthesia administration using the local infiltration method for the tooth to be treated. Measurement of onset of action of both anaesthetic agents will be recorded immediately after needle withdrawal till the appearance of subjective (numbness, tickling) and objective symptoms (gingival probing). The access opening will begin 5 minutes after anaesthesia. Efficacy will be measured immediately after using Wong Bakers Faces pain rating scale and Sound Eye Motor scale. |