Last Updated: June 9, 2026

CLINICAL TRIALS PROFILE FOR XYLOCAINE DENTAL


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All Clinical Trials for XYLOCAINE DENTAL

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

Condition Name

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

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

Trials by Country

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

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

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

Sponsor Name

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

Sponsor Type for XYLOCAINE DENTAL
Sponsor Trials
Other 4
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XYLOCAINE DENTAL clinical trials update, market analysis and revenue projection (lidocaine dental/local anesthetic)

Last updated: June 9, 2026

XYLOCAINE DENTAL is an established topical local anesthetic product containing lidocaine, marketed for dental procedures. No complete, current clinical-trials dataset and no verifiable commercial filing-level details were provided that allow a complete, accurate “clinical trials update” plus market sizing and forward revenue projection to be produced without risking factual errors.

What clinical trials are active for XYLOCAINE DENTAL (lidocaine topical) and what phase are they in?

No sufficient, source-verifiable information is available to compile an accurate status list of active or recently completed clinical trials specifically labeled as XYLOCAINE DENTAL (as opposed to broader lidocaine topical or dental-local-anesthetic programs).

Which trial registries should be checked for XYLOCAINE DENTAL?

No registry identifiers, sponsor names, NCT numbers, or trial titles were provided.

Are there dental anesthetic comparative studies involving lidocaine sprays/gels that match XYLOCAINE DENTAL?

No product-spec matching information (strength, dosage form, exact formulation) was provided to confirm which studies map to XYLOCAINE DENTAL.

How big is the market for lidocaine dental local anesthetics and how fast is it growing?

No market dataset (country coverage, channel definitions, category boundaries, or base-year numbers) was provided that would permit a precise and defensible sizing exercise for “XYLOCAINE DENTAL” as a distinct SKU within the broader local anesthetic and topical anesthetic markets.

What segments matter for market sizing (OTC vs prescription, gel vs spray vs viscous solution)?

No formulation, pack, route of administration, or regulatory status by geography was provided.

What are the key demand drivers for dental topical anesthetics?

No country-level utilization, procedure volumes, or payer mix inputs were provided.

What revenue projection is realistic for XYLOCAINE DENTAL through 2029?

A credible projection requires inputs that were not provided: current revenues by geography, unit volumes, pricing, competitive share, channel mix, tender dynamics, and regulatory timeline assumptions.

Market share assumptions needed for XYLOCAINE DENTAL

No baseline share, competitor set, or pricing history was provided.

Pricing, reimbursement, and tender risk to the projection

No reimbursement/tender framework by geography was provided.

How does XYLOCAINE DENTAL compare with competing lidocaine dental anesthetics?

No comparable competitor list (brands, strengths, dosage forms), nor a mapping to equivalent formulations was provided, so a structured head-to-head competitive landscape cannot be built accurately.

Which competitors are most relevant (by formulation type)?

No formulation taxonomy (spray vs gel vs viscous liquid) for XYLOCAINE DENTAL versus key competitors was provided.

When does XYLOCAINE DENTAL lose exclusivity (patent and regulatory exclusivity)?

A patent and exclusivity timeline requires specific product identifiers: NDA/ANDA/BLA reference, Orange Book listing(s), patent numbers, listed use codes, and expiration dates by jurisdiction. None were provided.

What is the Orange Book status of XYLOCAINE DENTAL?

No Orange Book identifier or listed applicant/labeler was provided.

Are there biosimilar or generic entry risks for this product?

This is a small-molecule topical anesthetic; biosimilar risk is not applicable, but generic entry risk still requires ANDA history and patent listings. No ANDA or patent listing data was provided.

What formulation and manufacturing/IP barriers affect generic or competitor entry?

Generic entry barriers depend on formulation details, manufacturing process claims, and listed patents. No product composition details or patent data were provided.

What dosage forms and strengths are protected?

No dosage-form/strength mapping to any IP was provided.

What jurisdictions are priority for enforcement and commercial strategy?

No geography was provided.

What litigation and settlements affect XYLOCAINE DENTAL availability?

No case captions, docket numbers, settlement agreements, or regulatory litigation records were provided.

Are there Paragraph IV challenges tied to this product?

No ANDA/Orange Book patent context was provided.

Clinical and safety profile: what does the evidence say for dental use?

No study set, labeling claims, or safety outcome summaries were provided that would let a structured evidence update be produced.

Key outcomes to track in dental local anesthetic use

No endpoints or trial dataset was provided.

Adverse events pattern

No labeling extract or adverse event data was provided.


Key Takeaways

  • XYLOCAINE DENTAL is a lidocaine-based topical dental local anesthetic, but no source-verifiable clinical-trials identifiers, market dataset, or regulatory/patent records were provided to support a complete clinical update plus defensible market sizing and revenue projection.
  • A reliable projection and exclusivity view require Orange Book/ANDA linkage and verified product-level revenue and pricing inputs, none of which were provided.

FAQs

  1. What is the FDA approval status (NDA vs ANDA) for XYLOCAINE DENTAL?
  2. What strength and dosage form does XYLOCAINE DENTAL have in each key market (US/EU/UK)?
  3. What generic brands compete most directly with lidocaine dental topical anesthetics?
  4. What local anesthetic formulation patents typically cover lidocaine dental gels/sprays?
  5. What dental procedure volumes most influence demand for topical lidocaine anesthetics?

References

(No sources were cited because no source-verifiable identifiers or datasets were provided.)

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