Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001014347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
19/02/2026
Date registered
Help: Date registered
18/08/2026
Date last updated
Help: Date last updated
18/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Buffered Lidocaine on painless anesthesia in patients with painful teeth.
Scientific title
Effects of Buccal Infiltration of Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block in Mandibular First Molars with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Additional trial identifiers [1] 316493 0
Nil
Universal Trial Number (UTN)
U1111-1335-9186
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Oral Anesthesia 340750 0
Symptomatic Irreversible Pulpitis 340751 0
Condition category
Condition code
Oral and Gastrointestinal 336928 336928 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 337593 337593 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The procedure will be started by administering buccal infiltration with Sodium Bicarbonate mixed with 1% Lidocaine and Epinephrine in one group. Buffering of the local anesthetic will be performed with a hand mixing protocol. A 1ml sterile syringe will be used to withdraw 0.18 ml of local anesthetic solution from the 1.8 ml carpule followed by injection of 0.18 ml of sodium bicarbonate 8.4% solution into the carpule obtaining a ratio of 9:1 between the local anesthetic solution and the sodium bicarbonate. Every patient will be administered a buffered lidocaine carpule according to their wight. For every kg of weight, a 0.18ml buffered lidocaine solution will be used.

After 15 minutes, lip numbness will be checked by asking the patient and if present, an inferior alveolar nerve block will be administered using 1% Lidocaine with 1:1000,000 Epinephrine.
After another 15 minutes lip and tongue numbness will be confirmed again by asking the patient, and access cavity will be prepared. The treatment will be completed within 1 hour, and patient will be given a VAS to confirm their level of pain. VAS readings of 0 will be taken as ‘no pain’, 1-3 as ‘mild pain’, 4-7 as ‘moderate pain’ and 8-10 as ‘severe pain’. The total duration of the intervention will be 1 hour. The medical records will be reviewed to check if the patient follows regular appointments.
Intervention code [1] 333252 0
Treatment: Drugs
Description of the comparator or control
The control group will be administered with buccal infiltration of 1.8% Lidocaine and 1:1000,000 Epinephrine without buffering the lidocaine.
Every patient will be administered a buffered lidocaine carpule according to their weight. For every kg of weight of the patient, a 0.18ml buffered lidocaine solution will be used.
After 15 minutes an inferior alveolar nerve block will be administered using Lidocaine with 1:1000,000 Epinephrine. After another 15 minutes lip and tongue numbness will be confirmed, and access cavity will be prepared. The treatment will be completed, and patient will be given a VAS to confirm their level of pain. VAS readings of 0 will be taken as ‘no pain’, 1-3 as ‘mild pain’, 4-7 as ‘moderate pain’ and 8-10 as ‘severe pain’.
Control group
Active

Outcomes
Primary outcome [1] 344452 0
Pain and anesthesia effect of buffered lidocaine after administering Inferior Alveolar Nerve Block and this will be assessed as a composite outcome.
Timepoint [1] 344452 0
Pain will be assessed 15 minutes after administering inferior alveolar nerve block
Secondary outcome [1] 460392 0
nil
Timepoint [1] 460392 0
nil

Eligibility
Key inclusion criteria
1. Patients aged 18–60 years.
2. Symptomatic irreversible pulpitis in mandibular 1st Molar teeth.
3. No periapical radiolucency on radiograph.
4. Vital pulp confirmed upon access.
5. No previously root canal treated tooth
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Allergies to any antibiotic used in the study.
2. Pregnant or lactating females.
3. Medically compromised patients.
4. Teeth with calcified canals or internal/external resorption.
5. Patients who used antibiotics or analgesics within the past 7 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The WHO sample size calculator was used to calculate the sample size.
Anticipated population proportion: 0.78
Anticipated population proportion: 0.44
Level of significance is 5%
Power of test is 90%
The sample size comes out to be 42 which was increased to 60 patients (30 in each group)


Data will be analyzed using SPSS version 23. For qualitative variables such as ‘gender’, frequency and percentage will be calculated. For quantitative variables such as ‘age’ and ‘pain score’, mean ± SD will be calculated. Chi square test will be used to compare the success after administration of local anesthesia for both groups. A p-value of less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/02/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
60
Accrual to date
46
Final
Recruitment outside Australia
Country [1] 27839 0
Pakistan
State/province [1] 27839 0
Punjab

Funding & Sponsors
Funding source category [1] 321194 0
Self funded/Unfunded
Name [1] 321194 0
Dr. Fatima Ali
Country [1] 321194 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Fatima Ali - Watim Medical and Dental College
Address
Country
Pakistan
Secondary sponsor category [1] 323812 0
Individual
Name [1] 323812 0
Dr. Ajmal Yousaf - Armed Forces Institute of Dentistry
Address [1] 323812 0
Country [1] 323812 0
Pakistan
Other collaborator category [1] 283856 0
Individual
Name [1] 283856 0
Dr. Noureen Akhtar - Armed Forces Institute of Dentistry
Address [1] 283856 0
Country [1] 283856 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319641 0
Institutional Ethical Review Board, Watim Medical and Dental College, Rawat Pakistan
Ethics committee address [1] 319641 0
Ethics committee country [1] 319641 0
Pakistan
Date submitted for ethics approval [1] 319641 0
10/02/2026
Approval date [1] 319641 0
18/02/2026
Ethics approval number [1] 319641 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 147958 0
Dr Fatima Ali
Address 147958 0
Watim Medical and Dental College, Main G.T. Road, Near T-Chowk, Rawat, Rawalpindi, Pakistan
Country 147958 0
Pakistan
Phone 147958 0
+923235778850
Fax 147958 0
Email 147958 0
[email protected]
Contact person for public queries
Name 147959 0
Fatima Ali
Address 147959 0
Watim Medical and Dental College, Main G.T. Road, Near T-Chowk, Rawat, Rawalpindi, Pakistan
Country 147959 0
Pakistan
Phone 147959 0
+923235778850
Fax 147959 0
Email 147959 0
[email protected]
Contact person for scientific queries
Name 147960 0
Fatima Ali
Address 147960 0
Watim Medical and Dental College, Main G.T. Road, Near T-Chowk, Rawat, Rawalpindi, Pakistan
Country 147960 0
Pakistan
Phone 147960 0
+923235778850
Fax 147960 0
Email 147960 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.