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Last Updated: April 4, 2025

CLINICAL TRIALS PROFILE FOR XYLOCAINE DENTAL WITH EPINEPHRINE


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All Clinical Trials for XYLOCAINE DENTAL WITH EPINEPHRINE

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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 (<30-sec) onset of action and comparatively less number of postsurgical complications14. Intravascular injection is extremely unlikely to occur15compared to IANB or infiltration. Assertions that intraseptal anaesthesia is immediate are properly consistent with previous clinical results. Their findings reported that the onset of action for anaesthesia was within one minute after injection. So the onset time can be considered rapid if not immediate. Disadvantages of intraseptal Injection Clinical experience and multiple tissue punctures may be necessary to perform this technique. During the anaesthetic procedure, the anaesthetic solution may leak in to the oral cavity resulting discomfort and an unpleasant or bitter taste. The effective period anaesthesia for pulpal and soft-tissues is very limited20 hence multiple repeats may be required for longer surgical procedures. The aim of this prospective clinical study is to determine the anesthetic efficacy of the supplemental intraseptal technique in mandibular teeth diagnosed with extraction when the conventional inferior alveolar
>Trial ID>Title>Status>Phase>Start Date>Summary
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Clinical Trial Conditions for XYLOCAINE DENTAL WITH EPINEPHRINE

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1Overcoming the Failure of Anesthesia in the Mandibular TeethPerioperative Analgesia During Third Molar Surgery ( Oral Surgery)Symptomatic Irreversible PulpitisOral Surgical Procedure[disabled in preview]
Condition Name for XYLOCAINE DENTAL WITH EPINEPHRINE
Intervention Trials
Overcoming the Failure of Anesthesia in the Mandibular Teeth 1
Perioperative Analgesia During Third Molar Surgery ( Oral Surgery) 1
Symptomatic Irreversible Pulpitis 1
Oral Surgical Procedure 1
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Condition MeSH

20-0.200.20.40.60.811.21.41.61.822.2Pulpitis[disabled in preview]
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

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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

33.3%33.3%33.3%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 3Phase 1N/A[disabled in preview]
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

100.0%000.511.522.53Completed[disabled in preview]
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

trials000001111111Taibah UniversityNational Medical College, Birgunj, NepalTribhuvan University, Nepal[disabled in preview]
Sponsor Name for XYLOCAINE DENTAL WITH EPINEPHRINE
Sponsor Trials
Taibah University 1
National Medical College, Birgunj, Nepal 1
Tribhuvan University, Nepal 1
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Sponsor Type

100.0%000.511.522.533.54Other[disabled in preview]
Sponsor Type for XYLOCAINE DENTAL WITH EPINEPHRINE
Sponsor Trials
Other 4
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Xylocaine Dental with Epinephrine: Clinical Trials, Market Analysis, and Projections

Introduction

Xylocaine Dental with Epinephrine, a local anesthetic solution containing lidocaine hydrochloride and epinephrine, is widely used in dental procedures for its effective anesthesia and hemostatic properties. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Mechanism of Action

Xylocaine Dental with Epinephrine works by stabilizing the neuronal membrane, inhibiting the ionic fluxes required for nerve impulse initiation and conduction. This mechanism provides effective local anesthesia for dental procedures[1][2].

Onset and Duration of Anesthesia

Clinical trials have shown that the onset of anesthesia for both 2% Xylocaine Dental with epinephrine 1:50,000 and 1:100,000 concentrations averages less than two minutes for infiltration anesthesia and 2-4 minutes for nerve blocks. The duration of pulp anesthesia is at least 60 minutes for infiltration and 90 minutes for nerve blocks, with soft tissue anesthesia lasting approximately 2.5 to 3.25 hours[1][2].

Comparative Studies

A cross-sectional double-blind study compared the anesthetic efficacy and cardiovascular parameters of 2% lidocaine solutions with epinephrine concentrations of 1:100,000 and 1:200,000. The study found that decreasing the epinephrine concentration did not affect the clinical efficacy of the anesthetic and showed clinical safety for cardiovascular parameters[5].

Market Analysis

Current Market Size

The local anesthesia drugs market, which includes Xylocaine Dental with Epinephrine, was valued at over USD 3.95 billion in 2024 and is expected to grow to USD 6.18 billion by 2037, with a CAGR of more than 3.5% during the forecast period[3].

Lidocaine Market Specifics

The lidocaine market, specifically, was valued at USD 2.43 billion in 2023 and is predicted to reach USD 3.68 billion by 2031, growing at a CAGR of 5.30%. This growth is driven by the extensive use of lidocaine in local anesthesia, pain management, and as an antiarrhythmic agent[4].

Factors Driving Growth

Several factors contribute to the market growth:

  • Increasing Surgical Procedures: The rise in cosmetic and other surgical procedures, as indicated by the 2,314,720 cosmetic surgical procedures performed in 2020, drives the demand for local anesthetics[3].
  • Advancements in Formulations: Innovations such as liposomal formulations and advanced delivery systems enhance efficacy and patient compliance, further boosting market demand[4].
  • Rising Healthcare Spending: Increasing healthcare spending in developing countries like India, Brazil, and China is expected to increase the number of surgeries and, consequently, the demand for local anesthetics[3].

Market Projections

Future Growth

The local anesthesia drugs market, including Xylocaine Dental with Epinephrine, is projected to continue growing due to several factors:

  • R&D Investments: Increased investments in healthcare and pharmaceutical research are expected to improve the efficiency of local anesthetic medications[3].
  • Expanding Applications: The growing acceptance of lidocaine for cosmetic applications, such as in dermatology, and its use in outpatient procedures will further bolster the market[4].

Regulatory Approvals

Regulatory approvals for new lidocaine formulations are facilitating market expansion. Companies are actively investing in research and development to enhance product offerings, which will contribute to the market's growth[4].

Safety and Contraindications

Contraindications

Xylocaine Dental with Epinephrine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations[1][2].

Warnings and Precautions

Dental practitioners must be well-versed in diagnosing and managing emergencies that may arise from the use of local anesthetic agents. Resuscitative equipment, oxygen, and other resuscitative drugs should be available. Aspiration before injection is recommended to minimize the likelihood of intravascular injection[1].

Key Takeaways

  • Clinical Efficacy: Xylocaine Dental with Epinephrine is highly effective in providing local anesthesia for dental procedures, with a rapid onset and prolonged duration of action.
  • Market Growth: The market for local anesthesia drugs, including Xylocaine Dental with Epinephrine, is expected to grow significantly due to increasing surgical procedures, advancements in formulations, and rising healthcare spending.
  • Safety Considerations: While the drug is generally safe, it is crucial to follow proper administration protocols and be prepared for potential emergencies.

FAQs

What is the mechanism of action of Xylocaine Dental with Epinephrine?

Xylocaine Dental with Epinephrine works by stabilizing the neuronal membrane, inhibiting the ionic fluxes required for nerve impulse initiation and conduction.

What are the typical dosages for Xylocaine Dental with Epinephrine?

Dosages depend on the patient's physical status, the area to be anesthetized, and the technique used. For most routine dental procedures, 1.0-5.0 mL (½ to 2½ cartridges) of 2% Xylocaine Dental with epinephrine 1:50,000 or 1:100,000 is usually effective[2].

What are the potential side effects of Xylocaine Dental with Epinephrine?

Potential side effects include dose-dependent hypertension, bradycardia, heart block, and in severe cases, methemoglobinemia, seizures, coma, arrhythmias, and death. Immediate treatment is required for severe reactions[1].

How does the market for local anesthesia drugs, including Xylocaine Dental with Epinephrine, project to grow?

The market is expected to grow from USD 3.95 billion in 2024 to USD 6.18 billion by 2037, driven by increasing surgical procedures, advancements in formulations, and rising healthcare spending[3].

What are some recent advancements in lidocaine formulations?

Recent advancements include liposomal formulations designed to provide sustained release and prolonged pain relief, enhancing treatment outcomes for patients undergoing surgical or dental procedures[4].

Sources

  1. FDA Label: 2% Xylocaine DENTAL with epinephrine 1:100,000 (Lidocaine HCl 2% and Epinephrine 1:100,000 Injection)[1].
  2. RxList: Xylocaine DENTAL Injection - lidocaine HCl and epinephrine[2].
  3. ResearchNester: Local Anesthesia Drugs Market Size & Share, Growth Report 2037[3].
  4. Data Bridge Market Research: Lidocaine Market Size, Share, Trends, & Report Analysis By 2031[4].
  5. SciELO: Clinical evaluation of different epinephrine concentrations for local anesthesia[5].

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