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A comparison between the effects of two substances for superficial anesthesia on human gums.

Comparative analysis of the effectiveness of EMLA®( Euthetic Misture of Local Anesthetic) (Prilocaine 2,5% and lidocaine 2,5%) and benzocaine 20% on topical anesthetic in human's gengival mucosa

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2n2gsw
Enrollment
Unknown
Registered
2017-12-11
Start date
2016-05-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, dissociative sensory loss

Interventions

The study presented a "split-mouth" methodology, which consisted of a single group, which one side of the mouth was for intervention and the other side for control. The sample consisted of 20 healthy
Drug
Procedure/surgery
Other
E03.155.086.231

Sponsors

Instituto Leão Sampaio de Ensino Universitário Ltda
Lead Sponsor
Instituto Leão Sampaio de Ensino Universitário Ltda
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers; not pregnant; non smokers; not infants; no history of allergies to local anesthetics; without chronic use of medications; with complete natural dentition and no reports of numbness in the face or oral cavity

Exclusion criteria

Exclusion criteria: Volunteers with chronic diseases; pregnant women; smoking; infants; with a history of allergy to the local anesthetic and changes in face and mouth sensitivity; volunteers who did not attend the second visit and who did not have the medical records completely filled

Design outcomes

Primary

MeasureTime frame
Primary Outcomes expected: Superior influence of EMLA® on benzocaine on the superficial tactile perception.;Primary outcomes observed:In the superficial tactile perception test, we observed a similar result between the side treated with EMLA® and the side that was treated with benzocaine, represented by a decrease of tactile response to higher pressures in the oral mucosa in the five minutes time point. However, when comparing both groups (EMLA® vs benzocaine), no statistical repercussions were observed at the evaluated times ( 5 minutes - p value:0.2; 10 minutes - p value:0.6; 20 minutes - p value:0.17; 30 minutes - p value:1). When we compare each group singly, we observed that, at the five minutes point of measurement, there were statistically significant values in the decrease of superficial tactile perception when compared to the moment prior to the application of anesthetic agents ( Benzocaine side: 5 minutes - p:0.01) and (EMLA® side: 5 minutes - p: 0.04).;Primary Outcomes expected: Superior influence of EMLA® on benzocaine on mechanical pain sensitivity.;Primary outcomes observed: The test of sensitivity to mechanical pain revealed that the patients presented minimal discomfort as attested by the visual and analog scale. A comparative analysis between the treatments with the two drugs demonstrated a slight increase in the mechanical sensitivity in the benzocaine side, at five minutes point (p:0.96), however, no statistical significant difference was observed at evaluated times, either in the intergroup analysis or in an isolated group assessment.;Primary Outcomes expected:Superior influence of EMLA® on benzocaine on sensitivity to needle penetration;Primary outcomes observed:In the test of sensitivity to needle penetration, the benzocaine - treated side was more sensitive to the painful stimulus when compared to the EMLA® - treated side, evidenced by higher visual analogue pain scores. In an intergroup analysis, we found a decrease in the pain sensitivity to

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactDavid Gondim

CENTRO UNIVERSITÁRIO DR. LEÃO SAMPAIO-UNILEÃO

davidalencar@gmail.com55-88-98837-1806

Outcome results

None listed

Source: REBEC (via WHO ICTRP)