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The use of a Topical Anesthetic (EMLA) to assess decreased pain during the Periodontal Probing exam

Placebo-controlled clinical trial on the effect of an Anesthetic Gel on pain prevention during Periodontal Probing

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-8h7b5dw
Enrollment
Unknown
Registered
2022-09-05
Start date
2019-01-01
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

Chronic Periodontitis

Interventions

Both the control and intervention groups were made up of 33 patients (split-mouth study). Two dental elements of each patient received placebo and the other two elements received the intervention crea

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Volunteers aged between 18 and 60 years; of both genders, with at least five teeth in each hemi-arch (including 16, 22, 36 and 32); who had probing sensitivity and features of chronic periodontitis with probing depth greater than or equal to 5mm

Exclusion criteria

Exclusion criteria: Use of prophylactic antibiotics before periodontal probing; psychiatric disorders or chronic pain; clotting disorders; anticoagulation therapy; pregnant or lactating women; congenital or idiopathic methemoglobinemia; treatment with methemoglobin inducing agents; allergic to anesthetics; use of steroidal or non-steroidal anti-inflammatory drugs in the three days prior to the start of the study and patients with acute periodontal pain, pulpitis, abscesses or other acute infections

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Topical application of EMLA 5% cream (lidocaine + prilocaine) is expected to reduce the prevalence of pain on probing from 77% to 40%. Thus, an alpha of 5% and a beta of 10% (90% power) were established, obtaining a minimum sample size of 33 volunteers for this clinical study. In addition to a reduction in pain on probing, it is expected to verify whether or not there is a difference in the degree of pain between groups (gender, age, among others) and between anterior and posterior dental elements;Outcome 1: The data obtained were submitted to two-factor ANOVA with repeated measures (anesthetic and type of tooth). The analysis showed no statistically significant difference between the application of anesthetic (35.4±23.7) and placebo (35.5±25.3), regardless of the type of tooth (p=0.982). There were also no differences between the types of teeth - molars and incisors - for pain reporting (p=0.303). Primary outcome measures showed that application of EMLA topical anesthetic gel is not effective in reducing probing pain in patients with chronic periodontal disease.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactDaniele de Oliveira

Universidade Estadual de Ponta Grossa

stricto.odonto@gmail.com+55 (42) 3220-3000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)