Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment

NCT03502135 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 17-0417
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients that are successfully anesthetized for endodontic treatment

  Anesthetic success is defined as having sufficiently anesthetize teeth to allow for endodontic treatment.

  From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)

Secondary Outcomes (4)

• Proportion of patients demonstrating sufficient pulpal anesthesia to commence treatment

  From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)

• Stage of anesthesia failure

  From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)

• Proportion of premolars vs. anterior teeth successfully anesthetized

  From beginning to end of endodontic treatment appointment (about 1 to 1.5 hours)

• Time of anesthesia failure after completion of anesthetic administration

  From administration of anesthesia to completion of endodontic treatment appointment (about 1 hour)

Study Arms (1)

Intranasal Anesthesia

EXPERIMENTAL

Two intranasal sprays of tetracaine HCl and oxymetazoline HCl nasal spray anesthetic administered 4 minutes apart into the nostril corresponding to the side of the treated tooth. If inadequate anesthetic response obtained within 10 minutes, a third spray will be administered and assessed for effective anesthesia after 4 minutes.

Drug: Tetracaine HCl and oxymetazoline HCl nasal spray

Interventions

Tetracaine HCl and oxymetazoline HCl nasal spray DRUG

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

Intranasal Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists class I or II
• Preoperative heart rate of 55 to 100 beats per minute
• Maximum blood pressure reading of 166/100 mmHg
• Maxillary anterior tooth or premolar with a diagnosis or treatment plan which indicates root canal treatment

You may not qualify if:

• Inadequately controlled thyroid disease
• Five or more nosebleeds in the past month
• Known allergy to any study drug or para-aminobenzoic acid
• History of methemoglobinemia
• Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
• Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

MeSH Terms

Conditions

Dental Pulp Diseases; Pulpitis

Interventions

Tetracaine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Asma Khan, DDS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-Arm, unblinded trial.

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 18, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share