Phase 3
Completed N=150
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults
Anesthesia
Source: ClinicalTrials.gov NCT01745380 ↗
Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. — 88; 14 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. |
88; 14 | — |
| SECONDARY Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years) |
87; 20.6; 90.3; 43.8 | — |
| SECONDARY Number of Participants With a Heart Rate Higher Than 125 Bpm |
0; 0 | — |
| SECONDARY Number of Participants With a Heart Rate Lower Than 50 Bpm |
4; 1 | — |
| SECONDARY Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg |
5; 2 | — |
| SECONDARY Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg |
1; 1 | — |
| SECONDARY Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg |
1; 1 | — |
| SECONDARY Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg |
1; 0 | — |
| SECONDARY Maximum Change From Baseline in Heart Rate |
5.3; 5.1 | — |
| SECONDARY Maximum Change From Baseline in Systolic Blood Pressure |
13.8; 9.2 | — |
| SECONDARY Maximum Change From Baseline in Diastolic Blood Pressure |
11.1; 6.4 | — |
| SECONDARY The Profile Over Time of Heart Rate |
71.0; 73.6; 68.0; 72.6; 67.5; 66.3 | — |
| SECONDARY Alcohol Sniff Test |
-0.8; 1.3 | — |
| SECONDARY The Profile Over Time of Systolic Blood Pressure |
123.1; 124.0; 128.6; 125.4; 117.3; 116.3 | — |
| SECONDARY The Profile Over Time of Diastolic Blood Pressure |
73.5; 74.7; 78.5; 75.2; 74.4; 67.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female 18 years of age or older.
- Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (anterior or premolar tooth #4 to #13) with no evidence of pulpal pathology.
- Normal lip, nose, eyelid, and cheek sensation.
- Able to understand and sign the study informed consent document, communicate with the Investigators, and understand and comply with the requirements of the protocol.
- Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure (the treatment tooth).
- Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
- Seated systolic blood pressure (SBP) between 95 and 150 mm Hg, inclusive, and seated diastolic blood pressure (DBP) between 60 and 100 mm Hg, inclusive.
Exclusion Criteria
- Inadequately controlled hypertension (blood pressure greater than 150/100 mm Hg).
- Inadequately controlled active thyroid disease of any type.
- Frequent nose bleeds (≥ 5 per month).
- Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
- History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
- History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
- Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
- Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
- Having received any investigational drug and/or participation in any clinical trial within the 30 days prior to study participation.
- History of congenital or idiopathic methemoglobinemia.
Data sourced from ClinicalTrials.gov (NCT01745380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.