Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06302907 |
| Other study ID # |
M/45- 14.1.2023 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 14, 2023 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Al-Wataniya University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
