Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04104789
Other study ID # HM20014136 - adult general
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date September 2020
Est. completion date October 2021

Study information

Verified date June 2020
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

In June 2016, an intranasal delivery system of local anesthesia called Kovanaze, gained FDA approval. 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.

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 in adults

2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

- 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.

Study Design


Intervention

Drug:
Kovanaze Nasal Spray
Intra-nasal local anesthetic
Articaine Injection
Local anesthetic

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate of pupal anesthesia % dental procedures completed without the need for rescue anesthesia immediately after dental procedure, an average of 3 hours
Secondary Spread of anesthesia Number of teeth anesthetized in maxillary arch immediately after dental procedure, an average of 3 hours
Secondary Change in Anxiety level Modified Dental Anxiety Scale - 5 item questionnaire assessing dental visit related anxiety on a 5 point scale ranging from 1 (not anxious) to 5 (extremely anxious). Scores range from 5 to 25. from baseline to immediately after dental procedure
Secondary Change in Blood pressure systolic and diastolic blood pressure will be assessed before and after the dental procedure from baseline to immediately after dental procedure
Secondary Change in heart rate from baseline to immediately after dental procedure
Secondary Change in pain Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm) from baseline to immediately after dental procedure
Secondary Satisfaction with Kovanaze 8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze immediately after dental procedure, an average of 3 hours
Secondary Number of post treatment anesthesia side effects Phone survey asking about any side effects experienced from the anesthesia 24 hours
See also
  Status Clinical Trial Phase
Completed NCT04552132 - Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator N/A
Completed NCT04514991 - Bone Regenerative Techniques in Endodontic Microsurgery N/A
Completed NCT01904552 - Accuracy of ERCLMDs in Teeth With Apical Periodontitis Phase 1
Completed NCT05792787 - Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases
Completed NCT06072742 - Effect of Lifestyle on Caries and Apical Periodontitis
Completed NCT06226740 - Effectiveness of Different Obturation Techniques N/A
Completed NCT04126928 - Validation of PUFA Index in Assessing Untreated Dental Caries Among Malaysian Adult Subpopulation N/A
Recruiting NCT05439330 - Application of a Dental-dedicated MRI in the Diagnosis of Temporomandibular Joint Disorders, Tissue Alterations Related to Third Molars, Periapical and Periodontal Inflammatory Diseases, and Implant Treatment Planning N/A
Recruiting NCT06005545 - A Study to Compare Various Root Canal Cleaning Devices Based on Cavitation,Ultrasonic and Conventional Methods. N/A
Completed NCT02681276 - Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment N/A
Completed NCT04072926 - Effects of PDT and Bioceramic Filling on Periapical Healing and Postoperative Pain After Endodontic Retreatment Early Phase 1
Completed NCT03711942 - Comparison of Healing of Apical Periodontitis in Periodontally Diseased and Healthy Patients. N/A
Completed NCT03409887 - Effect of Intraorifice Barrier on Healing of Apical Periodontitis N/A
Completed NCT03171376 - Effect of Coronal Extent of Obturation on Endo-perio Lesions N/A
Recruiting NCT06043453 - Revitalization of Traumatized Immature Permanent Teeth
Completed NCT03987659 - Therapeutic Irrigation Procedures to Treat Apical Periodontitis N/A
Completed NCT03288467 - Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment N/A
Recruiting NCT03527602 - FE in Anterior Teeth N/A
Completed NCT04545307 - Transplantation of Allogeneic MSC in Patients With Pulp Necrosis and Chronic Apical Periodontitis Phase 2/Phase 3
Recruiting NCT03243357 - In Vivo Assessment of Endodontics Procedures N/A