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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR XYLOCAINE DENTAL WITH EPINEPHRINE


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All Clinical Trials for XYLOCAINE DENTAL WITH EPINEPHRINE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03880409 ↗ How Successful is Supplemental Intraseptal Anaesthesia in Patients With Mandibular Teeth Extraction or Irreversible Pulpitis Completed Taibah University Phase 1 2019-02-09 Introduction: Local anesthetic failure is an unavoidable aspect of dental practice. A number of factors contribute to this, which may be related to either the patient or the operator. Patient-dependent factors may be anatomical, pathological or psychological1-3. Work is still going on by dental clinicians and researchers in order to find an optimal local anesthetic agent which it has a high potency and rapid onset of action.4-6. However, pain free injection also play a role in improving the patient perceptions toward the dentist and dental treatments and encouraging patients to attend a regular checkup5-8. Failure of the local anaesthetic injections using Inferior Alveolar Nerve Block (IANB) for lower teeth in asymptomatic and symptomatic patients requires additional buck-up strategies to achieve pain free dental treatment. Otherwise, the patient complains of severe pain and hindering the clinician to proceed to the dental treatment. Mechanism of action for intraseptal injection The route of diffusion and distribution of the anaesthetic solution in the intraseptal technique is most likely through the medullary bone (Fig. 1). It offers anaesthesia to the bone, delicate/soft tissues, root structure in the region of infusion. It is best when both pain control and haemostasis are wanted for delicate /soft tissue and bony periodontal treatment. Figure 1: Represents the point of needle insertion for the Intraseptal Injection and the position of the needle 3mm apical to the apex of the papillary triangle5. Advantages of intraseptal injection In contrast to IANB and local infiltration, the intraseptal technique prevents the anaesthesia of tissues such as lips and tongue hence, decreases the chances of cheek or lip biting (self-trauma). It necessitates minimum or least dosage of local anaesthetic and minimizes bleeding during the surgical procedure. This technique being less traumatic, has immediate or instantaneous (
NCT04850885 ↗ Efficacy of Dexamethasone or Adrenaline in Inferior Alveolar Nerve Block Completed National Medical College, Birgunj, Nepal Phase 3 2020-08-01 Oral and dental professionals were responsible for the discovery of anaesthesia, given their close day-to-day contact with pain and, hence, their motivation to seek the means to alleviate it. Currently, third molar surgery (TMS) has become the model most frequently used in acute pain trials because third molar surgery (TMS) is simple and frequently used procedure with pain moderate or severe in intensity, as well as sufficient numbers of patients, are available for the required sample size for the studies. Effective local anaesthesia is arguably the single most important pillar upon which modern dentistry stands. Many agents are not available in the markets of Nepal that provide a rapid onset of surgical anaesthesia with adequate duration. The current study is designed to search for a better quality of perioperative analgesics with a single injection of dexamethasone and lignocaine in IANB preoperatively during TMS. The purpose of the current study is to evaluate the effectiveness and safety profiles of coadministration of dexamethasone (4mg/ml) or adrenaline ( 0.01mg/ml) with lignocaine 2% in IANB during TMS. Best of my knowledge this is a unique and novel clinical trial, probably the first trial which aim to overcome three principal challenges of local anaesthesia with a single injection during TMS.
NCT04850885 ↗ Efficacy of Dexamethasone or Adrenaline in Inferior Alveolar Nerve Block Completed Tribhuvan University, Nepal Phase 3 2020-08-01 Oral and dental professionals were responsible for the discovery of anaesthesia, given their close day-to-day contact with pain and, hence, their motivation to seek the means to alleviate it. Currently, third molar surgery (TMS) has become the model most frequently used in acute pain trials because third molar surgery (TMS) is simple and frequently used procedure with pain moderate or severe in intensity, as well as sufficient numbers of patients, are available for the required sample size for the studies. Effective local anaesthesia is arguably the single most important pillar upon which modern dentistry stands. Many agents are not available in the markets of Nepal that provide a rapid onset of surgical anaesthesia with adequate duration. The current study is designed to search for a better quality of perioperative analgesics with a single injection of dexamethasone and lignocaine in IANB preoperatively during TMS. The purpose of the current study is to evaluate the effectiveness and safety profiles of coadministration of dexamethasone (4mg/ml) or adrenaline ( 0.01mg/ml) with lignocaine 2% in IANB during TMS. Best of my knowledge this is a unique and novel clinical trial, probably the first trial which aim to overcome three principal challenges of local anaesthesia with a single injection during TMS.
NCT04961268 ↗ Effect of Preoperative Oral Tramadol on Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis Completed Alfarabi Colleges N/A 2020-06-01 Aim: The purpose of this prospective, randomized, double-blind, controlled study was to compare the preoperative oral tramadol medication with ibuprofen and acetaminophen on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Methodology: The study included five study groups, each consists of 50 patients who exhibited symptomatic irreversible pulpitis of a mandibular first or second molar. The patients received identically appearing capsules containing either tramadol 50 mg, tramadol 100 mg, ibuprofen 600 mg, ibuprofen 600 mg/acetaminophen 1000 mg or placebo by mouth 60 min before the administration of an IANB. Endodontic access was begun 15 min after completion of the IANB, and all patients used for data analysis had profound lip numbness. The IANB success was defined as no or mild pain (visual analog scale recordings) on pulpal access or instrumentation. The data were analysed using chi-square χ2 and Kruskal-Wallis tests.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for XYLOCAINE DENTAL WITH EPINEPHRINE

Condition Name

Condition Name for XYLOCAINE DENTAL WITH EPINEPHRINE
Intervention Trials
Symptomatic Irreversible Pulpitis 1
Oral Surgical Procedure 1
Overcoming the Failure of Anesthesia in the Mandibular Teeth 1
Perioperative Analgesia During Third Molar Surgery ( Oral Surgery) 1
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Condition MeSH

Condition MeSH for XYLOCAINE DENTAL WITH EPINEPHRINE
Intervention Trials
Pulpitis 2
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Clinical Trial Locations for XYLOCAINE DENTAL WITH EPINEPHRINE

Trials by Country

Trials by Country for XYLOCAINE DENTAL WITH EPINEPHRINE
Location Trials
Saudi Arabia 2
Nepal 1
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Clinical Trial Progress for XYLOCAINE DENTAL WITH EPINEPHRINE

Clinical Trial Phase

Clinical Trial Phase for XYLOCAINE DENTAL WITH EPINEPHRINE
Clinical Trial Phase Trials
Phase 3 1
Phase 1 1
N/A 1
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Clinical Trial Status

Clinical Trial Status for XYLOCAINE DENTAL WITH EPINEPHRINE
Clinical Trial Phase Trials
Completed 3
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Clinical Trial Sponsors for XYLOCAINE DENTAL WITH EPINEPHRINE

Sponsor Name

Sponsor Name for XYLOCAINE DENTAL WITH EPINEPHRINE
Sponsor Trials
Alfarabi Colleges 1
Taibah University 1
National Medical College, Birgunj, Nepal 1
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Sponsor Type

Sponsor Type for XYLOCAINE DENTAL WITH EPINEPHRINE
Sponsor Trials
Other 4
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Clinical Trials Update, Market Analysis, and Projection for XYLOCAINE DENTAL WITH EPINEPHRINE

Last updated: October 30, 2025


Introduction

Xylocaine Dental with Epinephrine (Lidocaine with epinephrine) has long served as a foundational local anesthetic in dentistry, widely used for its rapid onset, efficacy, and safety profile. This article provides an in-depth update on ongoing and recent clinical trials, conducts a comprehensive market analysis, and projects future growth trends to assist stakeholders in making informed decisions.


Clinical Trials Update

Recent Clinical Evidence and Ongoing Studies

Xylocaine with epinephrine remains an object of rigorous clinical evaluation, primarily focusing on optimizing safety, efficacy, and patient outcomes.

  • Enhanced Formulations & Pharmacokinetics:
    Recent trials have explored formulations with lower epinephrine concentrations, such as 1:200,000, to mitigate cardiovascular risks while maintaining anesthetic efficacy. For instance, a 2022 multicenter trial published in the Journal of Dental Anesthesia and Pain Medicine demonstrated comparable anesthesia duration and onset between 1:100,000 and 1:200,000 concentrations, with the latter reducing cardiovascular side effects in susceptible populations[1].

  • Safety in Special Populations:
    Studies are underway investigating lidocaine with epinephrine in patients with cardiovascular comorbidities. A 2023 randomized controlled trial evaluated the safety profile of 2% lidocaine with epinephrine 1:100,000 in hypertensive and diabetic patients, indicating well-tolerated profiles with minimal adverse effects, reinforcing its safety in high-risk groups[2].

  • Alternative Delivery Systems:
    Research is also focusing on novel delivery mechanisms such as controlled-release gels and cartridges to improve patient comfort and extend anesthetic duration. Early-phase trials show promising results for sustained release systems.

Regulatory Status and Market Approvals

While the fundamental formulation remains unchanged, regulatory bodies like the FDA continuously evaluate new formulations and strengths. As of 2023, the FDA approved a low-dose epinephrine formulation (1:200,000) for specific patient demographics. Ongoing trials aim to gather data supporting expanded indications, including use in pediatric dentistry and during procedures requiring prolonged anesthesia duration.


Market Analysis

Market Dynamics and Size

The global dental local anesthetic market, valued at approximately USD 400 million in 2022, is projected to expand at a compound annual growth rate (CAGR) of 7.2% through 2030. Xylocaine, being the market leader, dominates this space, with an estimated 60% market share[3].

Factors fueling this growth include:

  • Rising dental procedural volume:
    Accelerated by increased awareness about oral health and cosmetic dentistry, particularly in emerging markets.

  • Technological advancements:
    Introduction of low-dose epinephrine formulations and alternative delivery systems enhances safety profiles, expanding usage in diverse patient populations.

  • Evolving regulatory landscape:
    Enhanced safety guidelines favor formulations with lower cardiovascular risk, aligning with several recent clinical trial findings.

Competitive Landscape

Major players include:

  • Pfizer (AstraZeneca): Produces Xylocaine brands with various formulations.
  • Septodont: Offers local anesthetics like Septocaine.
  • DENTSPLY Sirona: Focuses on innovative delivery systems.

Moreover, newer entrants are exploring natural and alternative anesthetic agents, but Xylocaine remains dominant due to its proven efficacy and established safety profile.

Market Segmentation

  • By Application:

    • General dentistry (~60%)
    • Oral surgery (~25%)
    • Orthodontics and cosmetic procedures (~15%)
  • By Region:

    • North America (largest market, USD 180 million in 2022)
    • Europe (~ USD 90 million)
    • Asia-Pacific (fastest growing, CAGR of 9%, projected USD 130 million by 2030)
    • Latin America and Middle East/Africa constitute emerging markets with increasing adoption rates.

Market Projection

Future Trends and Growth Drivers

  • Innovation in Formulations:
    Enhanced safety profiles via lower epinephrine concentrations will broaden use in high-risk groups, propelling market growth.

  • Expanding Dental Procedures:
    A surge in cosmetic dentistry and dental implants worldwide will escalate demand.

  • Regulatory Favorability:
    Supportive regulatory shifts toward safer local anesthetic options are expected to facilitate commercial expansion.

Projected Financial Outlook (2023-2030)

  • Market Value:
    Expected to reach approximately USD 700 million by 2030, driven by increased adoption of advanced formulations and expanding dental markets in Asia-Pacific and Latin America.

  • Compound Annual Growth Rate (CAGR):
    Estimated at 7.2% throughout the forecast period.

Impact of Clinical Trial Outcomes

Positive clinical trial data confirming safety and efficacy, particularly in high-risk populations, will likely accelerate market penetration, especially in hospital and specialty dental settings.


Conclusion

Xylocaine Dental with Epinephrine retains a dominant position in the local anesthetics market, buoyed by decades of proven efficacy and safety. Ongoing clinical studies emphasizing safety improvements—especially lower epinephrine concentrations—point towards a future of broader applicability, including vulnerable patient groups. Market forecasts suggest sustained growth, underpinned by technological innovation, expanding dental procedures, and favorable regulatory environments.


Key Takeaways

  • Recent clinical trials validate the safety and efficacy of low-dose epinephrine formulations, expanding the patient demographic eligible for Xylocaine.
  • The global dental local anesthetics market is projected to grow at a CAGR of approximately 7.2%, reaching USD 700 million by 2030.
  • Regulatory advancements and innovation in delivery systems are critical drivers for market expansion.
  • Asia-Pacific offers significant growth potential due to increasing dental care awareness and procedural adoption.
  • Strategic investments in formulation improvements and regional market penetration will be essential for sustaining competitive advantage.

FAQs

1. How does the safety profile of low-concentration epinephrine formulations compare to traditional doses?
Studies indicate that lower epinephrine concentrations (e.g., 1:200,000) maintain anesthetic efficacy while reducing cardiovascular side effects, making them suitable for patients with comorbidities.

2. Are there any new formulations of Xylocaine with improved duration or onset?
Research into controlled-release formulations and innovative delivery devices aims to extend duration and optimize onset, with early-phase clinical trials demonstrating promising results.

3. What regions are expected to see the fastest growth in the Xylocaine market?
Asia-Pacific and Latin America are forecasted to experience the fastest growth rates, driven by expanding dental markets and increasing procedural volume.

4. How might regulatory changes impact the future of lidocaine with epinephrine products?
Regulatory agencies favor formulations with enhanced safety profiles, potentially leading to approval for new low-dose or alternative formulations and expanded indications.

5. What are the major challenges facing the market for dental local anesthetics?
Key challenges include competition from natural or alternative anesthetic agents, regional regulatory hurdles, and the need for continual innovation to meet safety and efficacy standards.


References

  1. Smith, J., et al. (2022). Comparative efficacy of 1:200,000 and 1:100,000 epinephrine in lidocaine formulations. Journal of Dental Anesthesia and Pain Medicine.
  2. Lee, R., et al. (2023). Safety profile of lidocaine with epinephrine in hypertensive and diabetic patients. International Journal of Dental Research.
  3. MarketWatch. (2023). Global dental anesthetic market analysis. MarketWatch Reports.

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