UnknownPhase 4

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

25 participantsStarted 2018-01-03

Plain-language 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.

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pulpal Blood Flow

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

Trial details

NCT IDNCT03368391

SponsorLouisiana State University Health Sciences Center in New Orleans

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-30

Contact for this trial

Janice A Townsend, DDS, MS

504-941-8250 jtown2@lsuhsc.edu

View on ClinicalTrials.gov More Local Anesthetic Drug Adverse Reaction trials