The Effect of Adding Sodium Bicarbonate 8.4% to Local Anesthesia on Pain During Upper Canine Infiltration
NCT ID: NCT06302907
Last Updated: 2024-03-12
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2023-01-14
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Buffered LA
AA buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site
Buffered Local anaesthesia
A buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site
Unbuffered Local anaesthesia
an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.
Unbuffered LA
an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.
Buffered Local anaesthesia
A buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site
Unbuffered Local anaesthesia
an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.
Interventions
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Buffered Local anaesthesia
A buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site
Unbuffered Local anaesthesia
an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.
Eligibility Criteria
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Inclusion Criteria
* 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
* pregnancy
15 Years
50 Years
ALL
Yes
Sponsors
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Al-Wataniya University
OTHER
Responsible Party
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Tarek Khaled Abou Agwa
Senior lecturer
Principal Investigators
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Tarek A Agwa, Senior Lect
Role: PRINCIPAL_INVESTIGATOR
Al Wataniya Private University
Locations
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Al Wataniya Private University
Hama, Hama Government, Syria
Countries
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Other Identifiers
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M/45- 14.1.2023
Identifier Type: -
Identifier Source: org_study_id
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