Comparing needle-free and traditional dental anesthesia methods
Randomized Prospective Split Mouth Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
This study is testing whether a needle-free way of numbing teeth works as well and feels more comfortable for adults getting dental work compared to the traditional needle method.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Louisiana State University Health Sciences Center in New Orleans Academic / other |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT06874244 on ClinicalTrials.gov |
What this trial studies
This study evaluates two methods of administering local anesthesia for dental procedures: the conventional needle and syringe method versus a needle-free approach using iontophoresis, which delivers a weak electrical current through electrodes to numb the teeth. Participants will receive either lidocaine hydrochloride or a combination of tetracaine and oxymetazoline through these methods. The goal is to determine the effectiveness and patient comfort associated with each technique. The study will involve adult participants who meet specific dental and health criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a sufficient number of healthy teeth and good oral hygiene.
Not a fit: Patients with severe dental issues such as rampant caries or chronic periodontitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more comfortable dental experience for patients by reducing pain associated with traditional needle injections.
How similar studies have performed: While the use of iontophoresis for anesthesia is a novel approach, similar studies have shown promise in reducing pain during dental procedures.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Orleans, Louisiana
- LSUHSC School of Dentistry — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Study coordinator: Amir Hossein Nejat, DDS
- Email: anejat@lsuhsc.edu
- Phone: 2052538459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.