EMLA Topical Anesthetic During Scaling and Root Planing

Topical Intrapocket Anesthesia With Prilocaine and Lidocaine as Alternative to Injectable Anesthesia During Scaling and Root Planing - A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Self-Perception; Local Anesthesia
• Intervention / Treatment: Drug: EMLA; Drug: Injectable anesthesia; Drug: 2% Benzocaine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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)	Drug: EMLA; % eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine; Other Names: EMLA®, AstraZeneca, Cotia, SP, Brazil
ACTIVE_COMPARATOR: 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)	Drug: Injectable anesthesia; Injectable anesthesia 2% lidocaine with epinephrine 1:100.000; Other Names: Alphacaine®, DFL, Rio de Janeiro, Brazil
ACTIVE_COMPARATOR: 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)	Drug: 2% Benzocaine; Topical anesthetic - 200mg/g of 2% benzocaine; Other Names: Benzotop ®, DFL, Rio de Janeiro, Brazil
PLACEBO_COMPARATOR: 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)	Drug: Placebo; Manipulated with the same appearance and viscosity of topical anesthetics mentioned above; Other Names: manipulated topical anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and discomfort	For each experimental tooth, the patient was asked to indicate the intensity of pain and discomfort experienced intraoperatively using the VAS (VAStrans) (5 minutes after the start of the instrumentation in each tooth) and postoperatively (VASpost) immediately after the end of instrumentation of the respective tooth. At the end of the procedure, the patient was asked to also describe the pain sensation of the tooth using VS as: no pain (0), mild pain (1), moderate pain (2), severe pain (3), or extremely severe pain (4).	For each tooth was evaluated intraoperative pain using the Visual Analog Scale (5 minutes after the start of the instrumentation) and postoperative immediately after instrumentation. At the end of the procedure, was asked Verbal Scale, for 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with anesthesia	Patient satisfaction with anesthesia was determined at the end of all treatment sessions using the following four categories: very satisfactory, satisfied, not satisfied, and completely unsatisfactory.	Determined at the end of all treatment sessions, for 4 weeks.
Injectable anesthetic requirement	Percentage of subjects injectable anesthesia requirements in different anesthetic groups. In case of occurrence of pain during the subgingival SRP, an additional dose of the same anesthesic was repeated. If pain persisted after this second application, then an anesthesia infiltration/block was performed.	If pain persisted after this second application, then an anesthesia infiltration/block was performed, for 4 weeks.
Adverse Events	When each patient returned for the next treatment session, they were asked about the occurrence of pain, discomfort, localized ulceration, edema, or desquamation of the oral mucosa.	Determined when each patient returned for the next treatment session, for 4 weeks.

Collaborators and Investigators

• Sponsor: Franciscan University Center

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 18, 2013
• First Posted (ESTIMATE): May 22, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 22, 2013
• Last Update Submitted That Met QC Criteria: May 18, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Local anesthesia; Dental anesthesia; Pain measurement; Pain perception; Root planing
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Benzocaine
• Other Study ID Numbers: EMLA2012