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Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment

NCT03502135 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-11-16

No results posted yet for this study

Summary

Purpose:

To evaluate anesthetic efficacy and overall patient experience with use of Kovanaze tetracaine/oxymetazoline nasal spray for root canal treatment of vital premolar and anterior teeth needing root canal treatment.

Participants:

30 adult patients with a vital upper anterior or premolar tooth (#4-13) with a diagnosis indicating need root canal treatment and who are seeking treatment in the UNC Chapel Hill School of Dentistry.

Procedures (methods):

Qualifying patients will be anesthetized with tetracaine/oxymetazoline nasal spray anesthetic in order to facilitate completion of their clinically required, standard of care root canal treatment. Research procedures include blood pressure monitoring and pain assessment using a visual analogue pain scale.

Conditions

  • Endodontic Disease
  • Endodontic Inflammation
  • Local Anesthesia
  • Dental Anesthesia

Interventions

DRUG

Tetracaine HCl and oxymetazoline HCl nasal spray

Two intranasal sprays of anesthetic. Each spray delivers 0.2 mL of solution containing 6 mg tetracaine hydrochloride and 0.1 mg of oxymetazoline hydrochloride

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Asma Khan, DDS · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-06-30
Completion
2019-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03502135 on ClinicalTrials.gov