CLINICAL TRIALS PROFILE FOR XYLOCAINE DENTAL WITH EPINEPHRINE

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.

Clinical Trial Conditions for XYLOCAINE DENTAL WITH EPINEPHRINE

Condition Name

Condition Name for XYLOCAINE DENTAL WITH EPINEPHRINE
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

Condition MeSH

Condition MeSH for XYLOCAINE DENTAL WITH EPINEPHRINE
Intervention	Trials
Pulpitis	2

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

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

Clinical Trial Status

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

Clinical Trial Sponsors for XYLOCAINE DENTAL WITH EPINEPHRINE

Sponsor Name

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

Sponsor Type

Sponsor Type for XYLOCAINE DENTAL WITH EPINEPHRINE
Sponsor	Trials
Other	4

Last updated: May 6, 2026

XYLOCAINE DENTAL WITH EPINEPHRINE: Clinical Trials Update, Market Analysis, and Projections

What is the product and what is its clinical relevance?

XYLOCAINE DENTAL with EPINEPHRINE is a topical/local anesthetic dental formulation. In market practice it is used for local anesthesia and pain control in routine dental procedures, where epinephrine is added to (i) reduce local bleeding and (ii) prolong anesthetic effect through vasoconstriction.

From a development standpoint, this is a mature, off-patent active (lidocaine as the local anesthetic; epinephrine as the adjunct). Clinical novelty is typically driven by:

• reformulation (concentration, delivery vehicle, taste/viscosity, needle or applicator design)
• combination products aimed at procedural workflow (e.g., gels vs sprays vs cartridges)
• localized clinical studies in specific dental indications required for regulatory updates, labeling expansion, or equivalence

What does the current clinical trials landscape show?

A complete “live” clinical trials refresh requires access to registry feeds and up-to-date trial status. Under the constraints here, no verified, citable trial dataset was provided, so a full clinical trials update cannot be produced without risking false positives or outdated information.

Result: No registry-backed clinical trials update is issued.

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Market analysis: how the product competes

Where does XYLOCAINE DENTAL with EPINEPHRINE sit in dental anesthesia?

The dental local anesthesia market is typically segmented by:

• Mechanism: amide local anesthetics (lidocaine class) with or without vasoconstrictors (epinephrine)
• Form factor: topical gels/liquids, sprays, cartridges, and specialty dental applicators
• Use case: routine fillings, extractions, periodontal procedures, endodontic adjuncts, and pain control

XYLOCAINE DENTAL with EPINEPHRINE competes primarily with:

• other lidocaine/epinephrine topical products
• mepivacaine/epinephrine, articaine/epinephrine, and prilocaine products (where approved for dental use)
• generic equivalents and private label dental anesthetics

Pricing and reimbursement dynamics

For mature local anesthetics in dentistry, commercial performance is shaped less by clinical differentiation and more by:

• acquisition price and tender dynamics
• formulary adoption by dental networks
• inventory compatibility and shelf life
• substitution rates to equivalents

Because the active ingredient profile is mature, market share changes tend to occur through distribution and contracting rather than through new clinical outcomes.

Demand drivers

Demand generally correlates with:

• volume of in-office dental procedures
• outpatient dental utilization trends
• labor and supply chain stability (inventory stocking by clinics)
• competitive pressures from generics

Key competitive threats

The dominant risks are:

• therapeutic substitution to other anesthetic vasoconstrictor combos
• generic erosion if patent protection does not exist for the specific dosage form and concentration
• changes in dental guidelines or prescribing preference for specific anesthetic agents

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Projections: base-case, upside, and downside

What can be projected for XYLOCAINE DENTAL with EPINEPHRINE?

A rigorous projection requires at least one of the following: (i) recent sales/shipments, (ii) current market-size data by geography, or (iii) credible registry- or payer-linked signals. None were supplied, and the constraints here prevent issuing numerical forecasts without verified inputs.

Result: No numeric market-size or revenue projection is issued.

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Actionable business implications (without speculative numbers)

If you are planning R&D around this product class, what matters now?

Clinical differentiation in dental local anesthetics increasingly depends on practical performance. For XYLOCAINE DENTAL with EPINEPHRINE specifically, R&D and lifecycle strategy usually targets one or more of these levers:

1. Duration and onset by formulation

   • optimize viscosity, pH, and delivery mode for consistent mucosal coverage
   • maintain epinephrine stability and intended vasoconstrictor effect

2. Patient experience and clinician usability

   • reduce taste aversion and improve spread
   • deliver predictable dosing units and applicator ergonomics

3. Regulatory pathway efficiency

   • equivalence or supplemental labeling paths are more common than de novo efficacy claims in this category
   • targeted dental procedural studies may be needed to support specific labeling language

If you are evaluating investment or commercial strategy, what signals should you track?

Because the active ingredients are mature, monitor:

• tender and contract wins in dental networks
• distribution expansion (dental wholesalers and clinic group buying)
• generic competitor launches by dose form and concentration
• label expansions that enable broader procedure billing and adoption

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Key Takeaways

• XYLOCAINE DENTAL with EPINEPHRINE is a mature dental local anesthetic product where commercial performance is driven by contracting, distribution, and substitution rather than by new clinical breakthroughs.
• A clinical trials update and numerical market projections cannot be produced under the available, citable inputs constraint.
• The most actionable near-term levers for this product class are formulation and delivery optimization, labeling/indication expansions, and channel-level contracting.

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FAQs

1. Is XYLOCAINE DENTAL with EPINEPHRINE primarily a topical anesthetic used in dentistry?

Yes. It is used for local anesthesia and procedural pain control in dental settings, with epinephrine included to modify effect and bleeding.

2. What usually drives differentiation in dental local anesthetic products?

Formulation and delivery (onset/duration consistency, applicator design, patient experience), plus labeling scope.

3. Are new large-scale clinical trials common for this product class?

They are less common than in novel therapeutics. Many changes rely on equivalence and supplemental labeling rather than major new efficacy trials.

4. How does generic competition typically affect the market?

Generic substitution pressures pricing and forces differentiation to shift toward channel contracts, distribution coverage, and usability factors.

5. What are the most important commercial metrics to track?

Contract wins, inventory penetration across dental channels, and the competitive launch schedule of equivalent dose forms and concentrations.

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References

No sources were provided in the prompt, and no registry or market datasets were supplied for citation. Therefore, no APA-cited sources are included.