EMLA Topical Anesthetic During Scaling and Root Planing

Franciscan University Center

Status: Completed

Conditions: Pain, Postoperative; Local Anesthesia; Self-Perception

Treatments: Drug: Injectable anesthesia; Drug: EMLA; Drug: Placebo; Drug: 2% Benzocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01860235

EMLA2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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32 participants in 4 patient groups, including a placebo group

sextant 1

Experimental group

Description:

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

Treatment:

Drug: EMLA

sextant 2

Active Comparator group

Description:

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)

Treatment:

Drug: Injectable anesthesia

sextant 3

Active Comparator group

Description:

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)

Treatment:

Drug: 2% Benzocaine

sextant 4

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo