Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General
- Conditions
- Caries,DentalApical Periodontitis
- Interventions
- Registration Number
- NCT04104789
- Lead Sponsor
- Virginia Commonwealth University
- Brief Summary
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.
- Detailed Description
In June 2016, an intranasal delivery system of local anesthesia called Kovanaze, gained FDA approval. Kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face.
With the ability to avoid the traditional painful injection Kovanaze offers promise in the field of maxillary anesthesia and this study intends to:
1. Compare Kovanaze to conventional needle anesthetic in adults
2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Adults who require restorations in the maxillary teeth that would need local anesthesia
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Kovanaze Nasal Spray (General Practice) Kovanaze Nasal Spray Adults who require restorations in the maxillary teeth that would need local anesthesia Articaine Injections (General Practice Articaine Injection Adults who require restorations in the maxillary teeth that would need local anesthesia
- Primary Outcome Measures
Name Time Method Success rate of pupal anesthesia immediately after dental procedure, an average of 3 hours % dental procedures completed without the need for rescue anesthesia
- Secondary Outcome Measures
Name Time Method Spread of anesthesia immediately after dental procedure, an average of 3 hours Number of teeth anesthetized in maxillary arch
Change in Anxiety level from baseline to immediately after dental procedure Modified Dental Anxiety Scale - 5 item questionnaire assessing dental visit related anxiety on a 5 point scale ranging from 1 (not anxious) to 5 (extremely anxious). Scores range from 5 to 25.
Change in pain from baseline to immediately after dental procedure Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)
Satisfaction with Kovanaze immediately after dental procedure, an average of 3 hours 8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze
Number of post treatment anesthesia side effects 24 hours Phone survey asking about any side effects experienced from the anesthesia
Change in Blood pressure from baseline to immediately after dental procedure systolic and diastolic blood pressure will be assessed before and after the dental procedure
Change in heart rate from baseline to immediately after dental procedure