EMLA Topical Anesthetic During Scaling and Root Planing

NCT ID: NCT01860235

Last Updated: 2013-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-03-31

Brief Summary

Injectable anesthesics previous to subgingival scaling and root planing (SRP) presents some disadvantages like fear of the needle insertion, long-lasting effect and prolonged dampening of adjacent tissues. This study will compare the intrapocket anesthetic effectiveness of a skin topical anesthesic EMLA with intrapocket 2% benzocaine, intrapocket placebo and injectable anaesthesia for SRP in a Split-mouth, double-blind, clinical trial study.

Detailed Description

Objective: The aim of this study was to compare the effect of a eutectic mixture containing 25 mg/g of lidocaine and 25 mg/g of prilocaine (EMLA®) with injectable 2% lidocaine, topical benzocaine, and 2% placebo for reducing pain during subgingival scaling and root planing (SRP) procedures.

Methods: Thirty-two patients were enrolled in this split-mouth, double-blind randomized clinical trial. Patients were randomized to a sequence of four anesthetics: 25 mg/g lidocaine and 25 mg/g of 5% prilocaine (EMLA®), injectable 2% lidocaine, topical 2% benzocaine, or placebo. Pain and discomfort were measured using a Visual Analogue Scale (VAS) and Verbal Scale (VS). Patient satisfaction with anesthesia was also determined at the end of each treatment session.

Conditions

Local Anesthesia; Pain, Postoperative; Self-Perception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

sextant 1

Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (EMLA)

Group Type: EXPERIMENTAL

EMLA

Intervention Type: DRUG

% eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine

sextant 2

Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Injectable anesthesia)

Group Type: ACTIVE_COMPARATOR

Injectable anesthesia

Intervention Type: DRUG

Injectable anesthesia 2% lidocaine with epinephrine 1:100.000

sextant 3

Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (2% Benzocaine)

Group Type: ACTIVE_COMPARATOR

2% Benzocaine

Intervention Type: DRUG

Topical anesthetic - 200mg/g of 2% benzocaine

sextant 4

Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Placebo)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Manipulated with the same appearance and viscosity of topical anesthetics mentioned above

Interventions

EMLA

% eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine

Intervention Type: DRUG

Injectable anesthesia

Injectable anesthesia 2% lidocaine with epinephrine 1:100.000

Intervention Type: DRUG

2% Benzocaine

Topical anesthetic - 200mg/g of 2% benzocaine

Intervention Type: DRUG

Placebo

Manipulated with the same appearance and viscosity of topical anesthetics mentioned above

Intervention Type: DRUG

Other Intervention Names

EMLA®, AstraZeneca, Cotia, SP, Brazil; Alphacaine®, DFL, Rio de Janeiro, Brazil; Benzotop ®, DFL, Rio de Janeiro, Brazil; manipulated topical anesthetics

Eligibility Criteria

Inclusion Criteria

• eligible individuals for the study were selected from those requiring SRP with at least 2 experimental teeth in four of the six sextants.
• each experimental teeth had to present ≥ 1 site with probing depth ≥ 5 mm associated with BP after treatment of gingivitis (without marginal bleeding).
• furthermore, individual should present ≥ 18 years-old, have not ever done periodontal treatment and be able to understand Verbal Scale (VS) and Visual Analog Scale (VAS).

Exclusion Criteria

• patients that related allergy history or sensitivity reaction to any used amide or ester anesthetics form,
• who received anesthesia or sedation 12 hours before SRP,
• who presented ulcerated lesions or abscesses in the oral cavity,
• who presented oral pathologies with immediate surgical,
• who had prior abuse alcohol history, pregnant women,
• who presented uncontrolled hypertension or
• who had participated in a clinical trial of investigational drug before four months from the beginning of this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Franciscan University Center

OTHER

Sponsor Role: lead

Responsible Party

Raquel Pippi Antoniazzi

Topical intrapocket anesthesia with prilocaine and lidocaine as an alternative to injectable anesthesia during scaling and root planing - A randomized clinical trial

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EMLA2012

Identifier Type: -

Identifier Source: org_study_id