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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if buffered articaine, a type of dental anesthetic, results in less pain than non-buffered articaine during dental procedures. The study will compare these two forms of articaine to assess which is more effective at reducing pain. Suitable candidates for this trial are individuals needing dental work in the upper front teeth area who are otherwise healthy. Those with gum disease or structural issues with their teeth may not qualify. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that buffered articaine often provides better pain relief and comfort than non-buffered articaine. Studies have found that patients tolerate buffered articaine well, and it offers faster pain relief, especially during dental procedures like molar extractions.

Buffered articaine is widely used and has undergone extensive safety testing. For example, only about 13% of patients required extra doses for complete pain relief, indicating its general effectiveness at standard doses. No major safety concerns have been reported for buffered articaine, making it a promising option for managing pain.

Non-buffered articaine is also commonly used and considered safe, though it may not provide the same level of comfort and quick pain relief as buffered articaine. Overall, both types of articaine are known to be safe, but buffered articaine might offer better pain control. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Buffered articaine is unique because it offers a potentially more effective way to manage pain compared to traditional non-buffered articaine. Most local anesthetics, like non-buffered articaine, can take a while to start working and may cause discomfort due to their acidity. Buffered articaine, however, is adjusted to a pH level closer to the body's natural state, which can lead to faster onset and reduced pain upon injection. Researchers are excited about this approach because it could improve patient comfort and reduce waiting times during procedures, making it a promising alternative to current local anesthetic options.

What evidence suggests that this trial's treatments could be effective for pain?

This trial will compare buffered articaine with non-buffered articaine. Studies have shown that buffered articaine reduces pain more effectively than its non-buffered counterpart. Research indicates that buffered articaine works faster and provides longer-lasting pain relief, while also causing less pain during injection. Patients have reported feeling more comfortable and experiencing better numbness with buffered versions. These findings suggest that buffered articaine might be a more effective choice for managing pain compared to non-buffered articaine. ^{1 3 5 6 7}

Who Is on the Research Team?

Ahmed H Khalifa, PhD

Principal Investigator

Cleveland Dental Institute

Waleed Elmallah, PhD

Principal Investigator

Cleveland Dental Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11673001/

Buffered 4% Articaine Reduces Pain and Enhances ... Buffered 4% articaine provides superior anesthetic efficacy compared to non-buffered 4% articaine, enhancing patient comfort by reducing pain, accelerating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10260355/

Anesthetic efficacy of buffered 4% articaine for mandibular ... 4% articaine with epinephrine can benefit from buffering and provide better anesthetic behavior, with improved onset and less pain during injection.

3. journaljpri.com journaljpri.com/index.php/JPRI/article/download/1513/3033/3010

Randomized Clinical Trial of Anesthetic Efficacy of Buffered ... Our aim was to observe for the onset of action of the local anesthesia, its longevity and pain experienced by the patient during the endodontic therapy when.

4. dimensionsofdentalhygiene.com dimensionsofdentalhygiene.com/article/buffered-articaine-provides-the-next-leap-in-dental-pain-management/

Buffered Articaine Provides the Next Leap in Dental Pain ... More recently, Staedt et al9 reported superior anesthetic efficacy, reduced pain and onset, and increased duration when comparing buffered to ...

5. ospublishers.com ospublishers.com/pdf/JDS-1-106.pdf

Pain Response and Efficacy of Buffered Versus Non- ... Buffered anesthesia showed better pulpal anesthesia than non- buffered one (P < 0.001). Conclusion: Based on the results of this study, buffered ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/022466s009lbl.pdf

Reference ID: 5618647 - accessdata.fda.gov Approximately 13% of these pediatric patients required additional injections of anesthetic for complete anesthesia. Safety of doses greater than 7 mg/kg (0.175 ...

7. researchgate.net researchgate.net/publication/386119721_Buffered_4_Articaine_Reduces_Pain_and_Enhances_Anesthesia_in_Maxillary_Third_Molar_Extractions_A_Randomized_Double-Blind_Split-Mouth_Study

(PDF) Buffered 4% Articaine Reduces Pain and Enhances ... Buffered 4% Articaine Reduces Pain and Enhances Anesthesia in Maxillary Third Molar Extractions: A Randomized, Double-Blind Split-Mouth Study.