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Evaluation of the efficacy of the formulation of topical anesthesia of Lidocaine / Articaine 4% and Lidocaine / Prilocaine 2.5% with and without Sodium Bicarbonate in the mucosa located posterior to upper canine teeth

Evaluation of the efficacy of the topical formulation of Lidocaine / Articaine 4% and Lidocaine / Prilocaine 2.5% with and without Sodium Bicarbonate in palatal mucosa of upper canines

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-36y2xg
Enrollment
Unknown
Registered
2019-07-23
Start date
2019-08-01
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

Anxiety Disorders

Interventions

A total of 42 volunteers, 21 men, and 21 women will be selected from undergraduate and postgraduate students of the Dentistry Department of the Federal University of Sergipe. It will be applied to the
Drug
Procedure/surgery
D02.065.199.750
E03.155.086.231

Sponsors

Universidade Federal de Sergipe
Lead Sponsor
Universidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Criteria for inclusion of volunteers in the research: age between 18-35 years; ability to provide written consent; Undergraduate or graduate student of the dentistry department of the Federal University of Sergipe who has already undergone local anesthesia without intercurrences; Not having undergone anesthesia in the region in the two weeks prior to the study; Do not use medication that changes perception of pain in the 2 weeks prior to the study; Do not present systemic changes or a history of hypersensitivity to the drugs under study.

Exclusion criteria

Exclusion criteria: Individuals will be informed that it is permissible to leave the study at any time without any loss. The individual may be withdrawn from the study when he or she experiences an allergic reaction or clearly drug-related allergic reaction; To present non-drug-related systemic disease during the study, requiring concomitant therapy; Failure to comply with protocol requirements, including rules related to drug use, alcohol or lack of cooperation during the study.

Design outcomes

Primary

MeasureTime frame
All four groups of topical anesthetics present a latency time of fewer than 10 minutes and a duration of at least 10 minutes, verified through the dispositive, which contains calibrated filaments, mounted on supports and protected inside transparent tubes. The filaments are calibrated to undergo flexion with predetermined force. ;We also hope that the four topical anesthetics present efficiency in the control of pain during local anesthesia, verified through the visual analog scale, The Visual Analog Scale (EAV) is a 10cm line with no numbers or demarcations except at the ends where there are 0 (zero) and 10 (ten) markings. Marking 0 corresponds to no pain, and marking 10 is the worst possible pain. The classification of the pain is made by placing a vertical mark on the line; the distance between the mark and the extremities 0 and 10 is measured by a millimeter ruler, evaluating the painful sensitivity of the volunteer (Jensen, Karoly, and Braver, 1986).

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactAnne Caroline Gercina Dantas

Universidade Federal de Sergipe

annegerc@gmail.com+5579998554669

Outcome results

None listed

Source: REBEC (via WHO ICTRP)