Pain, unspecified
Conditions
Interventions
The study will be crossover, blind, with a randomized order of application, with a 1-week interval between sessions, for a total of three sessions. Equal amounts of 100 mg of the ointment will be appl
G2. lidocaine 2.5%, prilocaine 2.5% and Amitriptyline 5%
G3. lidocaine 2.5%, prilocaine 2.5% and 20% Acmella oleracea extract (7.5% spilantol)
G4. Nanocapsules of 2.5% lidocaine, 2.5% prilocaine and 5% amitriptyline on a topical basis
G5. Nanocapsules of 2.5% lidocaine, 2.5% prilocaine on a topical basis with 20% Acmella oleracea extract (7.5% spilantol)
G6. Topical base without active ingredients like placebo. The encodings will be done randomly using the Microsoft Office Excel 365 program using the formula “=INDEX(SORT BY(A1:A6
RANDOM ARRAY(A1:A6))
SEQUENCE(6))”, and in each session two anesthetic formulations will be tested. The study will be carried out on 36 volunteers with a total of 216 tests, and the applications will take place in the ord
6" and will be under the responsibility of collaborator Victor Augusto Benedicto dos Santos, ensuring that volunteers are completely unaware.
E03.155.086.231
HP4.018.602.600.862
Sponsors
Faculdade de Odontologia de Piracicaba- Universidade Estadual de Campinas
Faculdade de Odontologia de Piracicaba- Universidade Estadual de Campinas
Eligibility
Age
No minimum to 30 Years
Inclusion criteria
Inclusion criteria: Age 18 or older and under 30 years old. Both genders. Undergraduate and graduate students of the Piracicaba School of Dentistry. Having accepted and signed the Free and Informed Consent Form - Healthy individuals; those who do not present any type of comorbidity that could generate any risk to the volunteer during the study and do not use continuous medications. Previous experience with local anesthesia, previously with an anesthetic agent of the same class (amide), thus, we can state that they have already had topical use of a similar drug without negative responses. Absence of history of allergy or complications resulting from local anesthetic. Who does not use medications that alter the perception of pain. Upper premolars (14 and 24) healthy on both sides (absence of restorations). Responsive to the Pulp Tester electrical stimulus, an electrical impulse emitting device, called Pulp Tester (PTE) will be used
Exclusion criteria
Exclusion criteria: Pregnant women. Breastfeeding women. Under 18 years of age and 30 years of age or older. Refusal to adhere to treatment using topical drugs. Reporting allergies to any component of the formula. Taking antidepressants, anticonvulsants and anti-inflammatories. Presence of inflammation in the region. Being under direct supervision of researchers (developing some type of activity in undergraduate or graduate studies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to emonstrate the effectiveness of the formulations in anesthesia of topical treatments with lidocaine/prilocaine and amitriptyline or acmella oleracea in vestibular and palatal anesthesia of premolars, reducing puncture pain and pulp sensitivity, making the injection more comfortable for patients, whether adult or pediatric | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactSidney Raimundo
Faculdade de Odontologia de Piracicaba- Universidade Estadual de Campinas
Outcome results
None listed