Caries,DentalPhase 2NCT03962634
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric
A Phase 2 study testing Kovanaze Nasal Spray and Articaine Injection in people with Caries,Dental and Apical Periodontitis, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Caries,Dental, Apical Periodontitis
- What is being tested?
- Kovanaze Nasal Spray and Articaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2019to 17 Sep 2019
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
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.
Read the 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:
- Compare Kovanaze to conventional needle anesthetic children (at least 6 years of age and weighing > 20 kg)
- Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures
- Conditions
- Caries,Dental, Apical Periodontitis
- Being tested
- Kovanaze Nasal Spray, Articaine Injection
- Keywords
- Cavities
- Medical subject headings
- Dental Caries, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kovanaze Nasal SprayDrug
Also called Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10
Intra-nasal local anesthetic
Articaine InjectionDrug
Also called Septocaine
Local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Kovanaze Nasal Spray (Pediatrics) | Experimental | Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Receives: Drug: Kovanaze Nasal Spray |
| Articaine Injections (Pediatrics) | Active comparator | Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Receives: Drug: Articaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Pupal Anesthesia
% dental procedures completed without the need for rescue anesthesia
Measured: immediately after dental procedure, an average of 3 hours
Secondary outcomes (6)
Spread of Anesthesia
Number of teeth anesthetized in maxillary arch
Measured: immediately after dental procedure, an average of 3 hours
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.
Measured: from baseline to immediately after dental procedure
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)
Measured: immediately after dental procedure, an average of 3 hours
Change in Blood Pressure
Measured: from baseline to immediately after dental procedure
Change in Heart Rate
Measured: from baseline to immediately after dental procedure
Change in Pain
Emoji scale ranging from 1 (very negative face) to 7 (very positive face)
Measured: from baseline to immediately after dental procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start28 Aug 2019
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Why it stopped: Drug is no longer being manufactured
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.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parthasarathy Madurantakam, DDS, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962634
- Sponsor's protocol ID
- HM20014136 - pediatric
- Status last verified
- Nov 2020
- First submitted
- 21 May 2019
- Last updated
- 19 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03962634
- Acronym / sponsor ID
- HM20014136 - pediatric
- Conditions
- Caries,Dental, Apical Periodontitis
- Keywords
- Cavities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug is no longer being manufactured
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare Kovanaze to conventional needle anesthetic children (at least 6 years of age and weighing > 20 kg)
- Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kovanaze Nasal Spray (Pediatrics) | Experimental | Drug: Kovanaze Nasal SprayChildren >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth |
| Articaine Injections (Pediatrics) | Active comparator | Drug: Articaine InjectionChildren >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
- Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
Key exclusion criteria (6 listed)
- 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);
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 |
|---|---|---|
| Kovanaze Nasal SprayAlso: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10Intra-nasal local anesthetic | Drug | Kovanaze Nasal Spray (Pediatrics) |
| Articaine InjectionAlso: SeptocaineLocal anesthetic | Drug | Articaine Injections (Pediatrics) |
Primary outcome
Success Rate of Pupal Anesthesia
Time frame: immediately after dental procedure, an average of 3 hours
% dental procedures completed without the need for rescue anesthesia
6 secondary outcomes
Spread of Anesthesia
Time frame: immediately after dental procedure, an average of 3 hours
Change in Anxiety Level
Time frame: from baseline to immediately after dental procedure
Anxiety
Time frame: immediately after dental procedure, an average of 3 hours
Change in Blood Pressure
Time frame: from baseline to immediately after dental procedure
Change in Heart Rate
Time frame: from baseline to immediately after dental procedure
Change in Pain
Time frame: from baseline to immediately after dental procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Parthasarathy Madurantakam, DDS, PhD principal investigator
Virginia Commonwealth University
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 Kovanaze Nasal Spray and Articaine Injection in people with Caries,Dental and Apical Periodontitis, run by Virginia Commonwealth University 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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Nov 2020. 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 19 Nov 2020). 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?
Success Rate of Pupal Anesthesia (time frame: immediately after dental procedure, an average of 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2020.