Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructu… (NCT05912335) | Clinical Trial Compass
CompletedPhase 1
Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries
Brazil40 participantsStarted 2021-06-02
Plain-language summary
In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs (local anesthetic) - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA (topical anesthetic available on the market) and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).
Who can participate
Age range
18 Years – 35 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:
* Healthy participants
* No lesions in the study area
* Have already been submitted to local anesthesia without intercurrence
Exclusion Criteria:
* Used any drugs that change the pain sensibility 1 week before
* Smokers
* Alcoholic
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
1
Pain sensitivity assessment by Visual Analogue Scale after the puncture of the needle of the local anesthetic.