: Pulpal Blood Flow With the Use of Intra-nasal Anesthetic

NCT03368391 | Unknown Phase 4 FDA Drug

• 1 other identifier: 9924
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anesthetics with vasoconstrictors decrease pulpal blood flow but the impact of intranasal local anesthetics on blood flow is unknown. This blinded, randomized crossover clinical trial will compare the effects of different local anesthetics on anterior teeth in healthy volunteers. On separate study visits patients will receive either traditional injections or intranasal administration of the following solutions: 2% lidocaine with 1:100,000 epi, 3% mepivacaine, tetracaine HCl and oxymetazoline HCl, or saline. The following variables will be assessed: pulpal blood flow, pulpal sensibility, pain on administration, and adverse outcomes.

Conditions

Local Anesthetic Drug Adverse Reaction; Local Infiltration; Pulp Disease, Dental

Outcome Measures

Primary Outcomes (1)

• Change in Pulpal Blood Flow

  change in pulpal blood flow will be measured using doppler flowmetry

  baseline and 7, 12, 17, 32, 47, and 62 minutes after administration of anesthetics

Secondary Outcomes (16)

• Pulp sensibility

  baseline before administration of anesthetics

• Pulp sensibility

  5 minutes after administration of anesthetics

• Pulp sensibility

  10 minutes after administration of anesthetics

• Pulp sensibility

  15 minutes after administration of anesthetics

• Pulp sensibility

  30 minutes after administration of anesthetics

Study Arms (3)

Sequence 1

OTHER

All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits. Sequence 1 participants will receive the drugs in the following sequence: 1) tetracaine HCl and oxymetazoline HCl 2) 3% mepivacaine 3) 2% lidocaine with 1:100,000 epi

Drug: tetracaine HCl and oxymetazoline HCL; Drug: 2% Lidocaine with 1:100,000 epinephrine; Drug: 3% Mepivacaine with 1:100,000 epinephrine; Drug: saline intranasal; Drug: saline infiltration

Sequence 2

OTHER

All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits. Sequence 2 participant will receive the drugs in the following sequence: 1) 2% lidocaine with 1:100,000 epi 2) tetracaine HCl and oxymetazoline HCl 3) 3% mepivacaine

Drug: tetracaine HCl and oxymetazoline HCL; Drug: 2% Lidocaine with 1:100,000 epinephrine; Drug: 3% Mepivacaine with 1:100,000 epinephrine; Drug: saline intranasal; Drug: saline infiltration

Sequence 3

OTHER

All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits. Sequence 3 participants will receive the drugs in the following sequence: 1) 3% mepivacaine 2) 2% lidocaine with 1:100,000 epi 3) tetracaine HCl and oxymetazoline HCl

Drug: tetracaine HCl and oxymetazoline HCL; Drug: 2% Lidocaine with 1:100,000 epinephrine; Drug: 3% Mepivacaine with 1:100,000 epinephrine; Drug: saline intranasal; Drug: saline infiltration

Interventions

tetracaine HCl and oxymetazoline HCL DRUG

0.4 mL HCl and oxymetazoline HCl administered intranasally

Sequence 1; Sequence 2; Sequence 3

2% Lidocaine with 1:100,000 epinephrine DRUG

2.5 mL of 2% Lidocaine with 1:100,000 epi will be infiltrated at anterior teeth

Sequence 1; Sequence 2; Sequence 3

3% Mepivacaine with 1:100,000 epinephrine DRUG

2.5 mL of 3% Mepivacaine will be infiltrated at anterior teeth

Sequence 1; Sequence 2; Sequence 3

saline intranasal DRUG

0.4 mL intranasal saline will be administered as a placebo

Sequence 1; Sequence 2; Sequence 3

saline infiltration DRUG

2.8 mL of saline will be infiltrated at anterior teeth as a placebo

Sequence 1; Sequence 2; Sequence 3

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1 or 2 with no contraindications to the medications in this study
• no restorations on the anterior teeth, no sign of history of dental trauma, and a normal periodontium to be included

You may not qualify if:

• known hypersensitivity to tetracaine, benzyl alcohol ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, lidocaine, and mepivacaine -inadequately controlled hypertension or thyroid disease, frequent nose bleeds, or history of methemoglobinemia will not be eligible. Patients taking monoamine oxidase inhibitors are not eligible as well. Pregnant women will not be eligible as a precaution.
• Subjects will be excluded if they have restorations, traumatic occlusion, orthodontic appliance, pathologic discoloration of dentition, fixed retainer on maxillary anterior, resorption, pulp canal obliteration, previous endodontic therapy, history of trauma to maxillary anterior dentition, or a fractured tooth structure

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Tetracaine; Oxymetazoline; Lidocaine; Epinephrine; Mepivacaine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Piperidines

Study Officials

• Janice A Townsend, DDS, MS

  LSUHSC School of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janice A Townsend, DDS, MS

CONTACT

504-941-8250; jtown2@lsuhsc.edu

Scott Thayer, DDS

CONTACT

504-941-8199; sthaye@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the dentist who administered the study medications will know their identity but the participant, investigator who tests the teeth, and person calling for later outcomes will not know.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: triple blinded cross over randomized controlled trial

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 11, 2017
• Study Start: January 3, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 11, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share