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Last Updated: April 4, 2025

CLINICAL TRIALS PROFILE FOR XYLOCAINE DENTAL


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All Clinical Trials for XYLOCAINE DENTAL

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
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for XYLOCAINE DENTAL

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1Oral Surgical ProcedureOvercoming the Failure of Anesthesia in the Mandibular TeethPerioperative Analgesia During Third Molar Surgery ( Oral Surgery)Symptomatic Irreversible Pulpitis[disabled in preview]
Condition Name for XYLOCAINE DENTAL
Intervention Trials
Oral Surgical Procedure 1
Overcoming the Failure of Anesthesia in the Mandibular Teeth 1
Perioperative Analgesia During Third Molar Surgery ( Oral Surgery) 1
Symptomatic Irreversible Pulpitis 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
Intervention Trials
Pulpitis 2
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Clinical Trial Locations for XYLOCAINE DENTAL

Trials by Country

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

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
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
Clinical Trial Phase Trials
Completed 3
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Clinical Trial Sponsors for XYLOCAINE DENTAL

Sponsor Name

trials000001111111Taibah UniversityNational Medical College, Birgunj, NepalTribhuvan University, Nepal[disabled in preview]
Sponsor Name for XYLOCAINE DENTAL
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
Sponsor Trials
Other 4
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Xylocaine Dental: Clinical Trials, Market Analysis, and Projections

Introduction to Xylocaine Dental

Xylocaine Dental, also known as lidocaine hydrochloride, is a widely used local anesthetic in dental procedures. It is available in various formulations, including solutions with epinephrine, which act as vasoconstrictors to prolong the anesthetic effect.

Mechanism of Action and Clinical Pharmacology

Xylocaine Dental works by stabilizing the neuronal membrane, inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses. This mechanism provides effective local anesthesia for dental procedures. When used for infiltration anesthesia or nerve blocks, Xylocaine Dental with epinephrine has a rapid onset of action, typically within 2-4 minutes, and provides pulp anesthesia for at least 60-90 minutes and soft tissue anesthesia for approximately 2.5 to 3.25 hours[1].

Clinical Trials and Efficacy

Reversing the Effects of Lidocaine

One significant clinical trial focused on reversing the effects of lidocaine using Phentolamine Mesylate (PM). This study aimed to reduce the duration of soft tissue anesthesia following dental treatments. Participants who received PM injections showed a significant reduction in the duration of soft tissue anesthesia compared to those who received saline injections. Specifically, PM reduced the anesthesia duration in the lower lip by approximately one hour (104 vs 170 minutes) and in the tongue by about 50 minutes (83 vs 134 minutes)[4].

Safety and Adverse Effects

The same trial highlighted that PM is a safe and effective way to reverse the effects of lidocaine, with no serious adverse events reported. Minor adverse effects included post-operative pain and discomfort. This suggests that PM can be a valuable tool in managing prolonged soft tissue anesthesia, a common complaint after dental procedures[4].

Market Analysis

Global Market Size and Growth

The global lidocaine hydrochloride market is substantial and growing. In 2023, the market size was valued at USD 1.7 billion and is projected to reach USD 3.5 billion by 2032, registering a Compound Annual Growth Rate (CAGR) of around 8.7%[3].

Market Drivers

Several factors drive the growth of the lidocaine hydrochloride market:

  • Increasing Demand for Dental Procedures: The rising number of dental procedures, driven by the increasing need for dental care services and the growing prevalence of dental problems, significantly contributes to market growth[2][3].
  • Technological Advancements: Advances in surgical procedures and the increasing use of lidocaine for postoperative pain management also drive market expansion[3].
  • Retail Pharmacies: The retail pharmacies segment is expected to witness the highest growth during the forecast period due to increasing awareness and accessibility of lidocaine products[2].
  • Geographical Dominance: North America dominates the global lidocaine hydrochloride market, driven by factors such as an aging population, increased surgical procedures, and favorable reimbursement policies[2][3].

Market Projections

Regional Growth

North America is expected to maintain its dominance in the lidocaine hydrochloride market over the anticipated period. This region's growth is fueled by an increase in dentistry and other medical procedures, along with rising healthcare investments and technological advancements[3].

Distribution Channels

Retail pharmacies are emerging as key distribution channels for lidocaine hydrochloride products. The increasing prevalence of dental and cosmetic procedures, coupled with a surge in demand for efficient pain management solutions, drives the prominence of retail pharmacies in this market[2].

Key Statistics

  • Market Size: The global lidocaine hydrochloride market was valued at USD 1.7 billion in 2023 and is projected to reach USD 3.5 billion by 2032[3].
  • CAGR: The market is expected to grow at a CAGR of around 8.7% over the forecast period[3].
  • Dominant Segment: Dental procedures command a significant market share, driven by the widespread use of lidocaine hydrochloride in these applications[2].

Clinical Significance and Future Directions

The use of lidocaine hydrochloride in dental procedures is well-established, and its efficacy is supported by numerous clinical trials. The ability to reverse its effects using Phentolamine Mesylate adds a new dimension to patient care, allowing for quicker recovery from soft tissue anesthesia.

Future Research

Future research could focus on optimizing the formulation of lidocaine hydrochloride to enhance its anesthetic effects while minimizing side effects. Additionally, exploring other reversal agents and their safety profiles could further improve patient outcomes.

Key Takeaways

  • Mechanism of Action: Xylocaine Dental stabilizes neuronal membranes to inhibit nerve impulses.
  • Clinical Efficacy: It provides effective anesthesia for dental procedures with a rapid onset and prolonged duration.
  • Reversal Agents: Phentolamine Mesylate can safely reverse the effects of lidocaine, reducing the duration of soft tissue anesthesia.
  • Market Growth: The global lidocaine hydrochloride market is growing, driven by increasing dental procedures and technological advancements.
  • Regional Dominance: North America leads the market, with retail pharmacies being key distribution channels.

FAQs

What is the primary use of Xylocaine Dental?

Xylocaine Dental is primarily used for the production of local anesthesia in dental procedures through nerve block or infiltration techniques.

How does Xylocaine Dental work?

Xylocaine Dental works by stabilizing the neuronal membrane, thereby inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses.

What is the typical duration of anesthesia provided by Xylocaine Dental?

When used for infiltration anesthesia, Xylocaine Dental provides pulp anesthesia for at least 60 minutes and soft tissue anesthesia for approximately 2.5 hours. For nerve blocks, it provides pulp anesthesia for at least 90 minutes and soft tissue anesthesia for 3 to 3.25 hours[1].

Can the effects of Xylocaine Dental be reversed?

Yes, the effects of Xylocaine Dental can be reversed using Phentolamine Mesylate (PM), which significantly reduces the duration of soft tissue anesthesia[4].

What are the key drivers of the lidocaine hydrochloride market?

The key drivers include increasing demand for dental procedures, technological advancements, and the growing use of lidocaine in postoperative pain management, particularly in North America[2][3].

Sources

  1. FDA Label for 2% Xylocaine DENTAL with Epinephrine - accessdata.fda.gov
  2. Lidocaine Hydrochloride Market Size, Share, Global Analysis Report - Polaris Market Research
  3. Lidocaine Market Size, Share, Growth Forecast 2032 - Straits Research
  4. Reversing the Effects of 2% Lidocaine: A Randomized Controlled Trial - PubMed
  5. Lidocaine Market Size 2022-2030 - Increasing Prevalence Of Various Chronic Diseases - BioSpace

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