Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric

Stopped early · Phase 2

Conditions studied: Caries,Dental, Apical Periodontitis

In brief

The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.

Key facts

Study ID

NCT03962634

Run by

Virginia Commonwealth University

People needed

3

Starts

2019-08-28

Expected to finish

2019-09-17

Last updated by the study team

2020-11-19

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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
• Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia
• Additional Pediatric Inclusion Criteria:
• Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
• Additional Endodontic Inclusion Criteria:
• Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth
• Additional General Practice Inclusion Criteria:
• Adults who require restorations in the maxillary teeth that would need local anesthesia

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.

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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