| CTRI Number |
CTRI/2025/07/090391 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Buffered vs. Non-Buffered 4% Articaine for Pain Relief in Kids After a Common Dental Injection |
|
Scientific Title of Study
|
Comparative evaluation of buffered 4% articaine versus 4% articaine in pain perception following labial infiltration in children. |
| 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 PANDIT SUSAANA AUSTINE |
| Designation |
POST GRADUATE |
| Affiliation |
THE OXFORD DENTAL COLLEGE |
| Address |
Department of Pediatric and Preventive Dentistry, fourth floor, Room No 8, Bommanahalli, NH 44, Hongasandra, Bengaluru,
Bangalore
KARNATAKA
560068
India |
| Phone |
8332821028 |
| Fax |
|
| Email |
panditsusaanaaustine99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PANDIT SUSAANA AUSTINE |
| Designation |
POST GRADUATE |
| Affiliation |
THE OXFORD DENTAL COLLEGE |
| Address |
Department of Pediatric and Preventive Dentistry, fourth floor, Room No 8, Bommanahalli, NH 44, Hongasandra, Bengaluru,
Bangalore
KARNATAKA
560068
India |
| Phone |
8332821028 |
| Fax |
|
| Email |
panditsusaanaaustine99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYA SUBRAMANIAM |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
THE OXFORD DENTAL COLLEGE |
| Address |
Department of Pediatric and Preventive Dentistry, fourth floor, Room No 8, Bommanahalli, NH 44, Hongasandra, Bengaluru,
Bangalore
KARNATAKA
560068
India |
| Phone |
9844225624 |
| Fax |
|
| Email |
drpriyapedo@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pandit susaana austine |
| Address |
Bommanahalli, NH 44, Hongasandra, Bengaluru, |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PRIYA SUBRAMANIAM |
Bommanahalli, NH 44, Hongasandra, Bengaluru, |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| pandit susaana austine |
The Oxford Dental College, Bangalore |
Department of Pediatric and Preventive Dentistry, fourth floor, Room No 8, Bommanahalli, NH 44, Hongasandra, Bengaluru
Bangalore
KARNATAKA |
8332821028
panditsusaanaaustine99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Articaine |
1ml of 4% articaine with 1:100,000 epinephrine will be administered over a period of 60 seconds |
| Intervention |
Articaine buffered with 8.4% sodium bicarbonate |
1ml of buffered 4% articaine with 1:100,000 epinephrine will be administered over a period of 60 seconds |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate in the study.
2. Patients exhibiting Frankl’s behaviour rating 3 or 4.
3. Patients requiring non-surgical extraction of primary maxillary incisors.
4. Primary maxillary incisors that cannot be restored.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a known history of allergy to any of the constituents present in the local anesthetic agent.
2. History of medically compromised conditions.
3. Presence of acute dento-alveolar infection at the site of injection.
4. History of dental treatment in the past 6 months.
5. Presence of pathological lesion involving primary maxillary incisors.
6. Presence of pain in relation to primary maxillary incisors.
7. Patients who have taken analgesics in the last 24 hours.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the pain perception in pediatric patients following labial infiltration using buffered 4% articaine versus conventional (non-buffered) 4% articaine, as assessed by validated pain scales during labial infiltration. |
baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will include sixty children aged 4 to 8 who require extraction of primary maxillary incisors and who fulfill the criteria. The demographic details, brief case history, and clinical findings of each patient will be recorded. Following clinical examination, the Wong-Baker Faces Pain Rating Scale1 and Sound Eye Motor Scale1 will be explained to the patient. The children will be divided into 2 groups: Group 1: Thirty children will be administered buffered 4% articaine with 1:100,000 epinephrine (will be prepared prior to administration) Group 2: Thirty children will be administered 4% articaine with 1:100,000 epinephrine
Preparation of 4% buffered articaine solution: 0.18 ml of solution will be collected from 1.8ml cartridge of 4% articaine (1.8ml cartridge, Septanest®, marketed by Septodont Healthcare India Pvt. Ltd., Maharashtra, India) in a 1ml insulin syringe and then 0.18ml of 8.4% sodium bicarbonate (Sodac®, marketed by Uttaranchal Biotech Limited, Rudrapur, Uttarakhand, India) will be added into the cartridge just before administration. The children will be allocated to either of the groups using simple randomization. Following topical application of 8% lidocaine and 0.8% Dibucaine gel (Precaine, Pascal International, Inc, USA) for 1 minute at the site of injection, labial infiltration using a sterile disposable insulin syringe and 31gauge needle will be used to inject either 1ml of 4% articaine or 1ml of 4% buffered articaine. In both groups, the local anesthetic solution will be administered over a period of 60 seconds. The onset of anesthesia will be recorded every 30 seconds using a blunt probe on the labial and palatal aspects of the gingiva. It will be recorded in minutes as the interval between the time of administration to the time when the effect of anesthesia will be first reported. After achieving adequate anesthesia, the primary maxillary incisors will be extracted. The efficacy of anesthesia will be assessed by subjective and objective signs. Intraoperative pain will be recorded using the Wong-Baker Faces Pain Rating Scale1, where 0 indicates no pain and 10 indicates intense pain. The objective signs will be recorded using the Sound Eye Motor scale1, where 1 indicates comfort and 4 indicates painful.
|