Apical Periodontitis, Caries,Dental
Conditions
Keywords
Cavities
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. \[9\] 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. Even though success rates between 83 and 90 % have been reported for adults and children \>40kg, \[10\] FDA label (Section 14.2) provides data for children (\>10 kg) indicating that the drug is safe for use in children as long as the dose is adjusted to bodyweight of the child. \[9\] * One 0.1 mL spray for patients weighing 10 kg to less than 20 kg; * Two 0.1 mL sprays for 20 kg to less than 40 kg; or * Two 0.2 mL sprays for patients weighing 40 kg or more. 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 children (at least 6 years of age and weighing \> 20 kg) 2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures
Interventions
Intra-nasal local anesthetic
Local anesthetic
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Pupal Anesthesia | immediately after dental procedure, an average of 3 hours | % dental procedures completed without the need for rescue anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Level | from baseline to immediately after dental procedure | STAI-Y6 - 6 item youth questionnaire assessing anxiety on a 4 point scale ranging from 1 (Not at all) to 4 (very much). Scores range from 6 to 24. |
| Anxiety | immediately after dental procedure, an average of 3 hours | Venham Behavior rating scale - single item 6 point scale used by provider to rate child's behavior during treatment. Item ranges from 0 (no protest) to 5 (high protest, no cooperation from child) |
| Spread of Anesthesia | immediately after dental procedure, an average of 3 hours | Number of teeth anesthetized in maxillary arch |
| Change in Heart Rate | from baseline to immediately after dental procedure | — |
| Change in Pain | from baseline to immediately after dental procedure | Emoji scale ranging from 1 (very negative face) to 7 (very positive face) |
| Change in Blood Pressure | from baseline to immediately after dental procedure | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kovanaze Nasal Spray (Pediatrics) Children \>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth
Kovanaze Nasal Spray: Intra-nasal local anesthetic | 1 |
| Articaine Injections (Pediatrics) Children \>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
Articaine Injection: Local anesthetic | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | — | Total | Kovanaze Nasal Spray (Pediatrics) | Articaine Injections (Pediatrics) |
|---|---|---|---|---|
| Age, Continuous | — years | — | — | — |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment United States | — | 3 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | — | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | — | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
Success Rate of Pupal Anesthesia
% dental procedures completed without the need for rescue anesthesia
Time frame: immediately after dental procedure, an average of 3 hours
Population: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Secondary
Anxiety
Venham Behavior rating scale - single item 6 point scale used by provider to rate child's behavior during treatment. Item ranges from 0 (no protest) to 5 (high protest, no cooperation from child)
Time frame: immediately after dental procedure, an average of 3 hours
Population: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Secondary
Change in Anxiety Level
STAI-Y6 - 6 item youth questionnaire assessing anxiety on a 4 point scale ranging from 1 (Not at all) to 4 (very much). Scores range from 6 to 24.
Time frame: from baseline to immediately after dental procedure
Population: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Secondary
Change in Blood Pressure
Time frame: from baseline to immediately after dental procedure
Population: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Secondary
Change in Heart Rate
Time frame: from baseline to immediately after dental procedure
Population: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Secondary
Change in Pain
Emoji scale ranging from 1 (very negative face) to 7 (very positive face)
Time frame: from baseline to immediately after dental procedure
Population: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants
Secondary
Spread of Anesthesia
Number of teeth anesthetized in maxillary arch
Time frame: immediately after dental procedure, an average of 3 hours
Population: Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants