Dental Anesthesia EfficacyPhase 2NCT01302483
Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia
A Phase 2 study testing 3% tetracaine HCL with 0.05% oxymetazoline HCL and Lidocaine Injection in people with Dental Anesthesia Efficacy, run by St. Renatus, LLC at 1 site in United States.
Trial summary
The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Anesthesia Efficacy
- What is being tested?
- 3% tetracaine HCL with 0.05% oxymetazoline HCL and Lidocaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 65 years of age
- Sufficiently healthy as determined by the investigator to receive the test and control medications and undergo the scheduled dental procedure
- Required an operative restorative procedure on a single maxillary tooth, other than a maxillary second or third molar, with treatment time not expected to exceed 60 minutes
- Could breathe through both nostrils
- Had normal lip, nose, eyelid, and cheek sensations
- Could understand and sign the informed consent document
- Could communicate with the investigator
- Could understand and comply with the requirements of the protocol
Who cannot join
- Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal, neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of angle-closure glaucoma
- Clinically relevant sinus/nasal surgical history
- Baseline Visual Analog Scale value of > 36 (or greater than weak) at the treatment site
- Had not had dental work requiring a local anesthetic within the last 24 hours or had taken pain medications within the last 48 hours
- Required prophylactic antibiotics for subacute bacterial endocarditis (infectious endocarditis)
- Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or p-aminobenzoic acid (PABA), as found in PABA-containing sunscreens
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- Allergic to or intolerant of oxymetazoline, epinephrine, or preservatives in their solutions
- Had a current condition, such as nasal congestion or sinus infection, that may have influenced responses to study medications
- History of alcoholism and/or drug abuse
- Had taken a monamine oxidase inhibitor within the past 3 weeks
- Were nursing, pregnant, suspected of being pregnant, or trying to become pregnant (females were required to take a urine pregnancy test to rule out pregnancy)
- Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Single-Center, Randomized, Double-Blind, Active-Treatment-Controlled, Parallel-Group Study of the Efficacy of Kovacaine Nasal Spray for Anesthetizing Maxillary Teeth in Healthy Dental Patients
The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.
Read the detailed description
The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provided anesthesia of the soft tissue and to evaluate the safety and tolerability of Kovacaine Mist and sham injection as compared to sham nasal spray and 2% lidocaine hydrochloride with 1:100,000 epinephrine submucosal injection and as determined by changes in vital signs and reports of side effects and adverse events.
- Conditions
- Dental Anesthesia Efficacy
- Being tested
- 3% tetracaine HCL with 0.05% oxymetazoline HCL, Lidocaine Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% tetracaine HCL with 0.05% oxymetazoline HCLDrug
1 sham injection along with 3 sprays of Kovacaine Nasal Spray in each nostril; a 4-minute interval between every set of sprays. The total dose of 3% tetracaine HCL with 0.05% oxymetazoline HCL was 18 mg/0.3 mg.
Lidocaine InjectionDrug
Each subject received both an injection along with 3 sprays of isotonic saline sham in each nostril; a 4-minute interval between every set of sprays.
| Study group | Role | What they receive |
|---|---|---|
| Kovacaine Nasal Spray | Experimental | 3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril Receives: Drug: 3% tetracaine HCL with 0.05% oxymetazoline HCL |
| Lidocaine Injection | Active comparator | .5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine Receives: Drug: Lidocaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulpal Anesthesia
Number of participants who did not need rescue anesthesia to complete the study dental procedure, i.e. Kovacaine provided enough pulpal anesthesia to complete a dental procedure.
Measured: Continuous throughout dental treatment period (up to 60 minutes)
Secondary outcomes (4)
Soft Tissue Anesthesia Duration
Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm^2 at the tissue site. At each time point, participants were asked if they felt pain from the sensor probe at each site location in the mouth. The four sites were:
- Site 1: Distal to the apex of the tooth in the position of the maxillary first premolar at the deepest point in the buccal vestibule
- Site 2: Apical to the maxillary lateral incisor at the deepest point in the labial vestibule
- Site 3: Incisive papilla
- Site 4: At the confluence of the alveolar process and hard palate medial to the maxillary second premolar (near the greater palatine foramen)
Measured: Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes
Maximum Change in Pulse From Baseline
Maximum change from Baseline at any time point.
Measured: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes
Maximum Change in Blood Pressure From Baseline
Maximum change from Baseline at any time point.
Measured: Baseline, 15, 20, 30, 40 50, 60, 120 minutes
Maximum Change in Pulse Oximetry From Baseline
Maximum change from Baseline at any time point
Measured: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startDec 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Anesthesia EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Renatus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ground Zero Pharmaceuticals, Rho, Inc.
- Responsible party
- Sponsor
- Investigators
- Sebastian G Ciancio, DDS, Principal investigator, Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302483
- Sponsor's protocol ID
- SR 2-01
- Status last verified
- Jun 2015
- First submitted
- 18 Feb 2011
- Last updated
- 17 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ciancio SG, Hutcheson MC, Ayoub F, Pantera EA Jr, Pantera CT, Garlapo DA, Sobieraj BD, Almubarak SA. Safety and efficacy of a novel nasal spray for maxillary dental anesthesia. J Dent Res. 2013 Jul;92(7 Suppl):43S-8S. doi: 10.1177/0022034513484334. Epub 2013 May 20.
PubMed 23690356
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Center, Randomized, Double-Blind, Active-Treatment-Controlled, Parallel-Group Study of the Efficacy of Kovacaine Nasal Spray for Anesthetizing Maxillary Teeth in Healthy Dental Patients
- ClinicalTrials.gov ID
- NCT01302483
- Acronym / sponsor ID
- SR 2-01
- Conditions
- Dental Anesthesia Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- St. Renatus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ground Zero Pharmaceuticals, Rho, Inc.
- Study start
- Dec 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Posted 17 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.
Detailed description
The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provided anesthesia of the soft tissue and to evaluate the safety and tolerability of Kovacaine Mist and sham injection as compared to sham nasal spray and 2% lidocaine hydrochloride with 1:100,000 epinephrine submucosal injection and as determined by changes in vital signs and reports of side effects and adverse events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kovacaine Nasal Spray | Experimental | Drug: 3% tetracaine HCL with 0.05% oxymetazoline HCL3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril |
| Lidocaine Injection | Active comparator | Drug: Lidocaine Injection.5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female between 18 and 65 years of age
- Sufficiently healthy as determined by the investigator to receive the test and control medications and undergo the scheduled dental procedure
- Required an operative restorative procedure on a single maxillary tooth, other than a maxillary second or third molar, with treatment time not expected to exceed 60 minutes
- Could breathe through both nostrils
- Had normal lip, nose, eyelid, and cheek sensations
Key exclusion criteria (12 listed)
- Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal, neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of angle-closure glaucoma
- Clinically relevant sinus/nasal surgical history
- Baseline Visual Analog Scale value of > 36 (or greater than weak) at the treatment site
- Had not had dental work requiring a local anesthetic within the last 24 hours or had taken pain medications within the last 48 hours
- Required prophylactic antibiotics for subacute bacterial endocarditis (infectious endocarditis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3% tetracaine HCL with 0.05% oxymetazoline HCL1 sham injection along with 3 sprays of Kovacaine Nasal Spray in each nostril; a 4-minute interval between every set of sprays. The total dose of 3% tetracaine HCL with 0.05% oxymetazoline HCL was 18 mg/0.3 mg. | Drug | Kovacaine Nasal Spray |
| Lidocaine InjectionEach subject received both an injection along with 3 sprays of isotonic saline sham in each nostril; a 4-minute interval between every set of sprays. | Drug | Lidocaine Injection |
Primary outcome
Pulpal Anesthesia
Time frame: Continuous throughout dental treatment period (up to 60 minutes)
Number of participants who did not need rescue anesthesia to complete the study dental procedure, i.e. Kovacaine provided enough pulpal anesthesia to complete a dental procedure.
4 secondary outcomes
Soft Tissue Anesthesia Duration
Time frame: Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes
Maximum Change in Pulse From Baseline
Time frame: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes
Maximum Change in Blood Pressure From Baseline
Time frame: Baseline, 15, 20, 30, 40 50, 60, 120 minutes
Maximum Change in Pulse Oximetry From Baseline
Time frame: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23690356Ciancio SG, Hutcheson MC, Ayoub F, Pantera EA Jr, Pantera CT, Garlapo DA, Sobieraj BD, Almubarak SA. Safety and efficacy of a novel nasal spray for maxillary dental anesthesia. J Dent Res. 2013 Jul;92(7 Suppl):43S-8S. doi: 10.1177/0022034513484334. Epub 2013 May 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian G Ciancio, DDS principal investigator
Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3% tetracaine HCL with 0.05% oxymetazoline HCL and Lidocaine Injection in people with Dental Anesthesia Efficacy, run by St. Renatus, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulpal Anesthesia (time frame: Continuous throughout dental treatment period (up to 60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01302483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2015.