Clinical trial NCT01860235: EMLA Topical Anesthetic During Scaling and Root Planing
Official title: Topical Intrapocket Anesthesia With Prilocaine and Lidocaine as Alternative to Injectable Anesthesia During Scaling and Root Planing - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anesthesia
Pain, Postoperative
Self-Perception
Keywords: Local anesthesia
Pain measurement
Pain perception
Dental anesthesia
Root planing
Lead sponsor: Franciscan University Center
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain and discomfort
timeFrame: 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 outcomes:
measure: Patient satisfaction with anesthesia
timeFrame: Determined at the end of all treatment sessions, for 4 weeks.
measure: Injectable anesthetic requirement
timeFrame: If pain persisted after this second application, then an anesthesia infiltration/block was performed, for 4 weeks.
measure: Adverse Events
timeFrame: Determined when each patient returned for the next treatment session, for 4 weeks.
Other outcomes:
Locations:
Study officials:
References: