The Effect of Adding Sodium Bicarbonate 8.4% to Local Anesthesia on Pain During Upper Canine Infiltration

The Effect of Adding Sodium Bicarbonate 8.4% to Local Anesthesia on Pain During Upper Canine Infiltration: A Crossover Clinical Trial.

The aim of the present study was to evaluate the pain during local anesthetic buccal infiltration for the maxillary canines after adding Sodium Bicarbonate 8.4% during local anesthesia.

Study Overview

• Status: Enrolling by invitation
• Conditions: Local Anesthetic Complication
• Intervention / Treatment: Procedure: Buffered Local anaesthesia; Procedure: Unbuffered Local anaesthesia

Detailed Description

Materials and Methods The present research was approved by the Institutional Review Board of the College of Dentistry at Al Wataniya Private University (M/45- 14.1.2023).

30 healthy patients were recruited, aged between 15-50 years, and divided into two groups (15 males and 15 females). Every patient had to meet the following conditions:

• Caries free with no restorations, periapical lesions, or history of trauma at the site of injection.
• Willingness to participate in the study and ability to describe and evaluate their pain.
• No painkillers, or sedatives taken for at least 24 hours so that pain assessment isn't affected.
• No allergy to local anesthetics.
• No pregnancy. Each patient received buccal infiltration with the anesthetic solution alone at one upper canine site and local anesthetic with added sodium bicarbonate at the other site. The local anesthetic used was 2% Lidocaine with 1:80.000 Epinephrine produced by New-Stetic S.A.- Colombia. Whereas 8.4% Bicarbonate Sodium was produced by TCE - UK. Injections were performed using 25 mm short needles (Gauge 27) manufactured by C-K Dental - South Korea.

Consent for each patient was obtained before the clinical session. Local infiltration was performed using a one-third cartridge (0.6 mL) of the local anesthetic on one side and local anesthetic with added Sodium Bicarbonate on the counterpart side leaving 5 minutes between the injections.

Alkalinization of the local anesthetic was performed using the technique described by Saatchi et al13. 0.2 mL of the anesthetic solution was extracted using a tuberculin syringe and then discarded. 0.2 mL sodium bicarbonate was then loaded and added to the cartridge. Afterward, the solution was slowly shaken 20 times and ready to be administered with a cartridge syringe.

The 100 mm Visual Analog Scale VAS was utilized as the most commonly used assessment tool to determine the severity of the pain14 where 0 indicates that the patient does not feel pain, while 10 points to unbearable severe pain. The patients must rely on their own experience to confirm the pain's severity.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Hama Government
    • Hama, Hama Government, Syrian Arab Republic, 00000
      • Al Wataniya Private University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Caries free with no restorations, periapical lesions, or history of trauma at the site of injection.
• Willingness to participate in the study and ability to describe and evaluate their pain.
• No painkillers, or sedatives taken for at least 24 hours so that pain assessment isn't affected.

Exclusion Criteria:

• allergy to local anesthetics.
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Buffered LA; AA buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site	Procedure: Buffered Local anaesthesia; A buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site; Procedure: Unbuffered Local anaesthesia; an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.
Active Comparator: Unbuffered LA; an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.	Procedure: Buffered Local anaesthesia; A buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site; Procedure: Unbuffered Local anaesthesia; an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on injection	- Pain was measured on a visual analogue scale (VAS) starting from 0 which represents (no pain at all) and ending with 10 which represents (the most severe pain)	one week

Collaborators and Investigators

• Sponsor: Al-Wataniya University
• Investigators: Principal Investigator: Tarek A Agwa, Senior Lect, Al Wataniya Private University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2023
• Primary Completion (Actual): September 10, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lidocaine; Sodium bicarbonate; Upper canine infiltration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: M/45- 14.1.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No