Phase 3
Completed N=110
Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth in Adults
Anesthesia
Source: ClinicalTrials.gov NCT01710787 ↗
Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Aug 2017
Primary outcomePrimary: Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic. — 84.1; 27.3; 27.3 percentage of patients
◆ Published Evidence
Emerging
16citations · ~2 / year
Comparison of 3 intranasal mists for anesthetizing maxillary teeth in adults: A randomized, double-masked, multicenter phase 3 clinical trial.
Summary
The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.
Linked Publications
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Comparison of 3 intranasal mists for anesthetizing maxillary teeth in adults: A randomized, double-masked, multicenter phase 3 clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic. |
84.1; 27.3; 27.3 | — |
| SECONDARY Intraoral Soft-tissue Anesthesia (Yes/no) |
0; 0; 0; 19; 8; 0 | — |
| SECONDARY Number of Participants With a Heart Rate Higher Than 125 Bpm |
1; 0; 0 | — |
| SECONDARY Number of Participants With a Heart Rate Lower Than 50 Bpm |
1; 2; 0 | — |
| SECONDARY Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg |
2; 1; 0 | — |
| SECONDARY Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg |
0; 0; 0 | — |
| SECONDARY Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg |
1; 0; 0 | — |
| SECONDARY Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg |
1; 0; 0 | — |
| SECONDARY Absolute Maximum Change From Baseline in Heart Rate |
9.4; 10.5; 7.0 | — |
| SECONDARY Absolute Maximum Change From Baseline in Systolic Blood Pressure |
13.7; 10.8; 5.1 | — |
| SECONDARY Absolute Maximum Change From Baseline in Diastolic Blood Pressure |
10.5; 7.3; 6.7 | — |
| SECONDARY The Profile Over Time of Heart Rate |
76.5; 75.1; 74.8; 75.3; 76; 76.3 | — |
| SECONDARY The Profile Over Time of Systolic Blood Pressure |
121.3; 118.6; 118.5; 125.0; 122.0; 121.5 | — |
| SECONDARY The Profile Over Time of Diastolic Blood Pressure |
75.0; 75.3; 74.8; 79.6; 77.7; 77.3 | — |
| SECONDARY Alcohol Sniff Test |
19.2; 18.8; 21.2; 18; 17.7; 20.9 | — |
| SECONDARY Intraoral Soft-tissue Anesthesia (Onset and Duration) |
9.7; 19.5; 37.0; 79.2; 32.1; 26.0 | — |
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 (other than a maxillary first, second, or third molar) 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.
- Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
- Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.
Exclusion Criteria
- Inadequately controlled hypertension (blood pressure greater than 140/90 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 last 24 hours.
- 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 30 days prior to study participation.
- Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
- History of congenital or idiopathic methemoglobinemia
Data sourced from ClinicalTrials.gov (NCT01710787) and the linked publication. 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.