Buffered vs Non-Buffered Articaine for Pain

Overseen By Jana Aboul-Hassan, Resident

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Cleveland Dental Institute

Disqualifiers: Periodontal disease, Bone loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

108 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Buffered vs Non-Buffered Articaine for Pain is an effective drug?

The available research shows that buffered articaine can be more effective than non-buffered articaine for pain management. Studies indicate that buffered articaine has a faster onset, meaning it starts working quicker, and it also lasts longer, providing extended relief. Additionally, patients experience less pain during the injection with buffered articaine compared to non-buffered articaine. This suggests that buffering articaine can enhance its effectiveness as a pain management drug. ^{1 2 3 4 5}

What safety data exists for buffered and non-buffered articaine?

The studies provided focus on the efficacy and anesthetic properties of buffered and non-buffered articaine, including comparisons with other anesthetics like lidocaine and bupivacaine. They evaluate factors such as pain on injection, onset, duration of anesthesia, and anesthetic success. However, specific safety data or adverse effects are not detailed in the abstracts. Generally, articaine is considered a successful anesthetic agent for dental procedures, with buffered formulations potentially offering faster onset and longer duration with less pain on injection. ^{1 2 3 4 6}

Is Buffered Articaine a promising drug for pain relief compared to Non-Buffered Articaine?

Buffered Articaine is promising because it tends to work faster, lasts longer, and is less painful when injected compared to Non-Buffered Articaine. ^{1 2 3 5 7}

What is the purpose of this trial?

Pain after buffered versus non buffered articaine.

Research Team

Waleed Elmallah, PhD

Principal Investigator

Cleveland Dental Institute

Ahmed H Khalifa, PhD

Principal Investigator

Cleveland Dental Institute

Eligibility Criteria

This clinical trial is open to individuals who are experiencing pain and require local anesthesia. Specific eligibility criteria for participation have not been provided, which suggests that the study may be broadly inclusive.

Inclusion Criteria

I need dental work on my front upper teeth.

Medically free

Exclusion Criteria

Radiographic bone loss

My teeth are not of normal length.

I have gum disease affecting my teeth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either buffered or non-buffered articaine local anesthetic for dental treatment

Immediate

Follow-up

Participants are monitored for pain response using the Numerical Rate Scale (NRS) immediately after treatment

Immediate

Treatment Details

Interventions

• Buffered Articaine
• Non Buffered Articaine

Trial Overview The trial is investigating the difference in post-injection pain between two types of local anesthetics: buffered articaine and non-buffered articaine. Participants will receive one of these treatments to compare their effects on pain levels.

Participant Groups

Group I: Buffered articaine Experimental Treatment 1 Intervention

Group II: non buffered articaine Active Control 1 Intervention

Buffered Articaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Articaine HCl for:

• Local, infiltrative, or conductive anesthesia in both simple and complex dental procedures

Approved in European Union as Articaine hydrochloride for:

• Local, infiltrative, or conductive anesthesia in both simple and complex dental procedures

Approved in Canada as Articaine HCl for:

• Local, infiltrative, or conductive anesthesia in both simple and complex dental procedures

Who Is Running the Clinical Trial?

Cleveland Dental Institute

Lead Sponsor

Trials

6

Recruited

440+

Findings from Research

In a randomized clinical trial involving volunteers receiving maxillary supraperiosteal anesthesia, 2% buffered articaine demonstrated similar anesthetic efficacy to 4% non-buffered articaine, with no significant differences in the onset or duration of anesthesia.

The buffered 2% articaine solution resulted in significantly less pain during injection compared to the non-buffered solution, making it a more comfortable option for patients while maintaining effective anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buffered 2% articaine versus non-buffered 4% articaine in maxillary infiltration: randomized clinical trial. Amorim, KS., Fontes, VTS., Gercina, AC., et al.[2021]

Buffered 4% articaine with epinephrine resulted in a significantly faster onset of anesthesia (4.5 minutes) compared to non-buffered articaine (6.6 minutes), indicating that buffering can enhance the effectiveness of the anesthetic.

Patients experienced less pain during injection with buffered articaine (7.8 mm on the VAS scale) compared to non-buffered articaine (11.3 mm), suggesting that buffering improves the overall comfort of the injection process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic efficacy of buffered 4% articaine for mandibular first molar infiltration: a crossover clinical trial. Manta, K., Dabarakis, N., Lillis, T., et al.[2023]

Buffered articaine, when used for maxillary primary molar extractions in children aged 4-10, resulted in significantly less pain during injection and a faster onset of anesthesia compared to non-buffered articaine, based on evaluations from 70 participants in a triple-blind randomized study.

The buffered articaine group also reported significantly less pain during the extraction process, indicating that buffering the anesthetic can enhance the overall experience for pediatric patients undergoing dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buffered articaine infiltration for primary maxillary molar extractions: a randomized controlled study. Dhake, P., Nagpal, D., Chaudhari, P., et al.[2022]

In a study of 82 patients undergoing cataract surgery, 2% articaine provided a faster onset of peribulbar anaesthesia, with an average readiness time of 4.2 minutes compared to 7.2 minutes for the bupivacaine/lidocaine mixture.

Articaine resulted in a denser block with significantly reduced eye movement scores at multiple time intervals, while showing a quicker offset of the anaesthesia, indicating its efficacy and safety as an alternative local anaesthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of articaine and bupivacaine/lidocaine for peribulbar anaesthesia by inferotemporal injection. Allman, KG., Barker, LL., Werrett, GC., et al.[2019]

In a study involving 80 adults, buffered 4% articaine did not show a significant advantage over nonbuffered 4% articaine in achieving pulpal anesthesia for mandibular first molar buccal infiltrations, with success rates of 71% and 65% respectively.

Both formulations had similar pain levels during injection and onset times for anesthesia, indicating that buffering the anesthetic does not enhance the overall effectiveness or comfort of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buffered 4% Articaine as a Primary Buccal Infiltration of the Mandibular First Molar: A Prospective, Randomized, Double-blind Study. Shurtz, R., Nusstein, J., Reader, A., et al.[2022]

In a double-blind study involving 20 healthy dental students, both articaine and lidocaine provided similar anesthetic effects for maxillary infiltration anesthesia, with no significant differences in onset or duration.

Each participant received 0.6 mL of both anesthetics, indicating that both options are effective for dental procedures without a clear advantage of one over the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Articaine and lidocaine for maxillary infiltration anesthesia. Vähätalo, K., Antila, H., Lehtinen, R.[2018]

In a study with 20 volunteers, the addition of sodium bicarbonate to local anesthetics significantly reduced pain during injection, with 18 out of 20 patients preferring the buffered solution.

The buffered anesthetic not only provided a less painful experience but also had a faster onset of action, while showing no difference in hemostasis or duration of anesthesia compared to unbuffered solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local anesthesia in rhinoplasty: a new twist? Metzinger, SE., Bailey, DJ., Boyce, RG., et al.[2013]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Buffered 2% articaine versus non-buffered 4% articaine in maxillary infiltration: randomized clinical trial. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Anesthetic efficacy of buffered 4% articaine for mandibular first molar infiltration: a crossover clinical trial. [2023]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Buffered articaine infiltration for primary maxillary molar extractions: a randomized controlled study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of articaine and bupivacaine/lidocaine for peribulbar anaesthesia by inferotemporal injection. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Buffered 4% Articaine as a Primary Buccal Infiltration of the Mandibular First Molar: A Prospective, Randomized, Double-blind Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Articaine and lidocaine for maxillary infiltration anesthesia. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Local anesthesia in rhinoplasty: a new twist? [2013]