Clinical trial NCT06874244: Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
Official title: Randomized Prospective Split Mouth Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Local Anesthesia Injection Pain
Keywords: Local Anesthesia
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: Henley Ion
First posted: 2025-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate two different ways to administer the numbing solution. One is with a conventional needle and syringe the other method iontophoresis is a machine that supplies a weak current through electrodes that touch your teeth. Both methods use an anesthesia solution to make your teeth numb but the iontophoresis system contains no needle and the delivery device does not penetrate the gum.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age at the time of consent

Subject is able to provide their own informed consent

Subject has a minimum 24 teeth/subject and 6 teeth per quadrant

Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents

Subject must be able to speak and understand English

Subject is able and willing to return for all scheduled study visits

Subject to able to make dental appointments

Subject should not be a pregnant female

Subject meets the Level-I or Level-II classification criteria of the American

Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care

Exclusion Criteria:

* Subject has any of the following:

  * rampant caries
  * chronic periodontitis
  * salivary gland dysfunction

Subject is unable, for any reason, to tolerate the procedure time required to place the restorations

Subject has unacceptable oral hygiene (e.g., chronic moderate to heavy plaque accumulation along the gumline)

Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study

Subject is using a whitening agent at any time during this study.

Subject has history of allergic reaction to anesthetic medications

Subject with uncontrolled systemic disease or conditions

Subject is having acute or chronic myofascial pain or neuropathic conditions

Subject taking long-term analgesics for their systemic conditions

Subject presenting with acute dental pain

Subject requiring IV sedation or nitrous oxide sedation or oral sedation for anxiety

Primary outcomes:
measure: Pain response in the gingiva
timeFrame: Up to 1 hour
measure: Electric pulp test
timeFrame: Up to 1 hour
measure: Cold pulp test
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Pain scale: Visual analog scale
timeFrame: Baseline and 2 minutes after delivery of anesthesia.
measure: Beck's anxiety scale
timeFrame: Baseline and 2 minutes after delivery of anesthesia.
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSUHSC School of Dentistry
state: Louisiana
Study officials:
References: