Local Anesthetic ComplicationNCT06302907
The Effect of Adding Sodium Bicarbonate 8.4% to Local Anesthesia on Pain During Upper Canine Infiltration
A study testing Buffered Local anaesthesia and Unbuffered Local anaesthesia in people with Local Anesthetic Complication, run by Al-Wataniya University at 1 site in Syria.
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. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthetic Complication
- What is being tested?
- Buffered Local anaesthesia and Unbuffered Local anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 14 Jan 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- allergy to local anesthetics.
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Local Anesthetic Complication
- Being tested
- Buffered Local anaesthesia, Unbuffered Local anaesthesia
- Keywords
- Upper canine infiltration, Lidocaine, Sodium bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffered Local anaesthesiaProcedure or surgery
A buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site
Unbuffered Local anaesthesiaProcedure or surgery
an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.
| Study group | Role | What they receive |
|---|---|---|
| Buffered LA | Active comparator | AA buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site Receives: Procedure: Buffered Local anaesthesia; Procedure: Unbuffered Local anaesthesia |
| Unbuffered LA | Active comparator | an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment. Receives: Procedure: Buffered Local anaesthesia; Procedure: Unbuffered Local anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start14 Jan 2023
- Primary completion10 Sep 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Anesthetic ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Wataniya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Khaled Abou Agwa, Al-Wataniya University
- Investigators
- Tarek A Agwa, Senior Lect, Principal investigator, Al Wataniya Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302907
- Sponsor's protocol ID
- M/45- 14.1.2023
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Sodium Bicarbonate 8.4% to Local Anesthesia on Pain During Upper Canine Infiltration: A Crossover Clinical Trial.
- ClinicalTrials.gov ID
- NCT06302907
- Acronym / sponsor ID
- M/45- 14.1.2023
- Conditions
- Local Anesthetic Complication
- Keywords
- Upper canine infiltration, Lidocaine, Sodium bicarbonate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Wataniya UniversityUniversity, hospital or other
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buffered LA | Active comparator | Procedure: Buffered Local anaesthesia, Procedure: Unbuffered Local anaesthesiaAA buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site |
| Unbuffered LA | Active comparator | Procedure: Buffered Local anaesthesia, Procedure: Unbuffered Local anaesthesiaan unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- allergy to local anesthetics.
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buffered Local anaesthesiaA buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site | Procedure or surgery | Buffered LA, Unbuffered LA |
| Unbuffered Local anaesthesiaan unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment. | Procedure or surgery | Buffered LA, Unbuffered LA |
Primary outcome
Pain on injection
Time frame: one week
- 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek A Agwa, Senior Lect principal investigator
Al Wataniya Private University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buffered Local anaesthesia and Unbuffered Local anaesthesia in people with Local Anesthetic Complication, run by Al-Wataniya University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on injection (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.