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

NCT03368391 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-12-11

No results posted yet for this study

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

Interventions

DRUG

tetracaine HCl and oxymetazoline HCL

0.4 mL HCl and oxymetazoline HCl administered intranasally

DRUG

2% Lidocaine with 1:100,000 epinephrine

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

DRUG

3% Mepivacaine with 1:100,000 epinephrine

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

DRUG

saline intranasal

0.4 mL intranasal saline will be administered as a placebo

DRUG

saline infiltration

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

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    lead OTHER

Principal Investigators

  • Janice A Townsend, DDS, MS · LSUHSC School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2018-06-30
Completion
2018-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368391 on ClinicalTrials.gov