| CTRI Number |
CTRI/2024/04/065819 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare pain perception, onset and duration of four drugs by local infiltration: lignocaine, buffered lignocaine, articaine and buffered articaine in milk teth. |
|
Scientific Title of Study
|
Comparison of Pain Perception and Efficacy of Infiltration Technique
using Lignocaine, Buffered Lignocaine, Articaine and Buffered Articaine
in primary teeth |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalyani Karwa |
| Designation |
Postgraduate student |
| Affiliation |
Saraswati Dhanwantari Dental College, Parbhani- 431401 |
| Address |
Room no. 6, Ground Floor, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental College and Hospital, Pathri road, Parbhani-431401
Parbhani
MAHARASHTRA
431401
India |
| Phone |
7038668899 |
| Fax |
|
| Email |
kalyanikarwa8711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rehan Khan |
| Designation |
Professor and head of department |
| Affiliation |
Saraswati Dhanwantari Dental College Parbhani |
| Address |
Room no. 6, Ground Floor, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental College and Hospital, Pathri road, Parbhani-431401
Parbhani
MAHARASHTRA
431401
India |
| Phone |
8237425282 |
| Fax |
|
| Email |
dent_dr1@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kalyani Karwa |
| Designation |
postgraduate student |
| Affiliation |
Saraswati Dhanwantari Dental College, Parbhani- 431401 |
| Address |
Room no. 6, Ground Floor, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental College and Hospital, Pathri road, Parbhani-431401
Parbhani
MAHARASHTRA
431401
India |
| Phone |
7038668899 |
| Fax |
|
| Email |
kalyanikarwa8711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 6, Ground Floor, Department of Pediatric and Preventive Dentistry, Saraswati Dhanwantari Dental College and Hospital, Pathri road, Parbhani-431401, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Kalyani Karwa |
| Address |
Saraswati Dhanwanatari Dental College, parbhani |
| 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 Kalyani Karwa |
Saraswati Dhanwantari Dental College, Parbhani |
Room no. 6, Ground Floor, Department of Pediatric and Preventive Dentistry, Pathri road, Parbhani-431401
Parbhani
MAHARASHTRA |
7038668899
kalyanikarwa8711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDDC PBN IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A: 2% Lignocaine hydrochloride with 1:80000 adrenaline Group B: buffered lignocaine (0.1ml of sodium bicarbonate added into 1.8 ml cartridge of 2% lignocaine with 1:80000 adrenaline, Group C: 4% articaine HCL with 1:100000 adrenaline, Group D: buffered articaine 0.1 ml of 8.4% sodium bicarbonate added into articaine with adrenaline cartridge. |
After giving local infiltration in patients of each group I will evaluate parameters. To each group infiltration will be given with standard septodont syringe with 30 gauge needle. Approximately 0.6ml of anaesthetic solution will be deposited slowly for 20 seconds. |
| Intervention |
Local infiltration in pediatric patients. |
After screening patient for inclusion criteria, the subjects will get divided in 4 groups. To each group local infiltration will be given with standard septodont cartridge of 30 gauge needle. Approximately 0.6ml of anaesthetic solution will be deposited slowly for 20 seconds. Then parameters will be evaluated. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
- Patients having at least one primary tooth requiring treatment (such as pulp therapy or extraction) under LA infiltration.
- Physically and mentally healthy children, without history of medications.
- Patients exhibiting Frankl’s behaviour rating grade of three or four
|
|
| ExclusionCriteria |
| Details |
- Children allergic to local anaesthesia
- Medically compromised children
- Children whose parents did not give consent to participate in the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
After the administration of LA, the following parameters will be
evaluated clinically,
1. Pain on injection
- Wong Baker FACES Pain Rating Scale
- Sound eye motor scale Pain during procedure
- Wong Baker FACES Pain Rating Scale
- Sound eye motor scale
3. Onset of anaesthesia
4. Duration of anaesthesia
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After the administration of anaesthesia onset & duration of anaesthesia is measured. |
At base line |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
26/04/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A detailed case history of patient aged 4-10 years will be taken. All 96 patients will be randomly divided into 4 groups with 24 in each group and local infiltration will be given to them. Four study groups will be: Group A- lignocaine infiltration group, Group B: Buffered lignocaine infiltration group, Group C: Articaine infiltration group, Group D: Buffered articaine infiltration group. After the administration of local infiltration pain on injection and pain during procedure will be measured with Wong Baker FACES pain rating scale and Sound eye motor scale. Efficacy will be checked by measuring onset and duration of anaesthesia. |