| CTRI Number |
CTRI/2026/04/108595 [Registered on: 17/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Different Local Anaesthesia Techniques for Pain Control in Upper First Molar Teeth with Severe Tooth Pain |
|
Scientific Title of Study
|
A parallel-arm randomized clinical trial evaluating the efficacy, injection pain, onset time, and duration of action of conventional 4 perctent articaine versus buffered 4 percent articaine versus buffered 4 percent articaine with palatal infiltration in patients with symptomatic irreversible pulpitis of maxillary first molars |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karan |
| Designation |
Post Graduate |
| Affiliation |
scb dental college and hospital |
| Address |
Department of Conservative dentistry And endodontics
Cuttack
ORISSA
753007
India |
| Phone |
6383772832 |
| Fax |
|
| Email |
ckkaran002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUBASISH BEHERA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Scb dental college and hospital |
| Address |
Department of Conservative Dentistry And Endodontics
Cuttack
ORISSA
753007
India |
| Phone |
9937034576 |
| Fax |
|
| Email |
dr.subasish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karan |
| Designation |
Post Graduate |
| Affiliation |
SCB Dental College And hospital |
| Address |
Department Of Conservative Dentistry And Endodontics
Cuttack
ORISSA
753007
India |
| Phone |
6383772832 |
| Fax |
|
| Email |
ckkaran002@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB Dental College And Hospital, Mangalabgh,Cuttack,Odisha 753007 |
|
|
Primary Sponsor
|
| Name |
DR KARAN C |
| Address |
SCB Dental College and Hospital,Mangalabag,Cuttack,Odisha 753007 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| karan |
SCB Dental College And Hospital |
Department Of Conservative Dentistry And Endodontics
Cuttack
ORISSA |
06383772832
ckkaran002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SCB Dental College & Hospital, Cuttack, Odisha |
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 |
Buffered 4 Percent Articaine |
4 Percent Articaine with 1:100000 epinephrine (1.8 mL) buffered with 0.18 mL of 8.4 Percent sodium bicarbonate immediately before administration. Given as buccal infiltration. |
| Intervention |
Buffered 4 Percent Articaine with Palatal Infiltration |
Buffered 4 Percent Articaine (1.8 mL) administered as buccal infiltration followed by 0.5 mL palatal infiltration. |
| Intervention |
Buffered Percent Articaine (Double Dose) |
Buffered 4 Percent Articaine (3.6 mL) administered as buccal infiltration using two cartridges. |
| Comparator Agent |
Conventional 4 Percent Articaine with Epinephrine |
4 Percent Articaine with 1:100000 epinephrine (1.8 mL) administered as buccal infiltration in maxillary first molar using 27 gauge needle at rate of 1 mL per minute after application of topical anesthetic gel. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 65 years with good general health, presenting with symptomatic irreversible pulpitis in maxillary first molar, having moderate to severe pain based on visual analogue scale, and willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases, presence of active infection at injection site, presence of periapical pathology, allergy to local anesthetics or sulfites, contraindication to epinephrine, pregnancy, intake of analgesics within past 12 hours, and pain in teeth other than maxillary first molar. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anesthetic success |
During Access Cavity Preparation[15-20 Minutes After Injection] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain during injection measured using Heft-Parker Visual Analog Scale (VAS) |
Immediately during injection (needle insertion, placement and deposition) |
| Onset time of anesthesia |
Time from injection to loss of response to cold test (assessed at 5,10,15 minutes) |
| Duration of anesthesia |
Time from onset of anesthesia until return of sensation as reported by patient |
| Need for supplemental anesthesia |
During endodontic procedure if pain is reported |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/07/2026 |
| 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="0"
Months="11"
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 randomized parallel group clinical trial will be conducted to evaluate the anesthetic efficacy of conventional 4 percent articaine, buffered 4 percent articaine, and buffered 4 percent articaine with palatal infiltration in patients with symptomatic irreversible pulpitis in maxillary first molars. Achieving adequate anesthesia in such cases is often challenging due to inflammatory changes in pulpal tissues. A total of 68 patients aged between 18 and 65 years will be randomly allocated into four groups. The interventions include conventional articaine, buffered articaine, double dose buffered articaine, and buffered articaine with additional palatal infiltration. Pain during injection, onset time, duration of anesthesia, and anesthetic success will be assessed using Heft Parker Visual Analog Scale and clinical evaluation.The study aims to determine whether buffering of articaine and use of supplemental palatal infiltration can improve anesthetic outcomes and patient comfort during endodontic procedures. The results of this study may help in optimizing anesthesia techniques for management of irreversible pulpitis in maxillary molars. |