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Completed

NCT Number: NCT01860235

EMLA Topical Anesthetic During Scaling and Root Planing

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.

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Key information

Conditions

Local Anesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Self-Perception Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMLA

Drug

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

Other names: EMLA®, AstraZeneca, Cotia, SP, Brazil

Injectable anesthesia

Drug

Injectable anesthesia 2% lidocaine with epinephrine 1:100.000

Other names: Alphacaine®, DFL, Rio de Janeiro, Brazil

2% Benzocaine

Drug

Topical anesthetic - 200mg/g of 2% benzocaine

Other names: Benzotop ®, DFL, Rio de Janeiro, Brazil

Placebo

Drug

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

Other names: manipulated topical anesthetics

Primary outcomes

  1. Pain and discomfort

    Time frame: 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.

    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).

Secondary outcomes

  1. Patient satisfaction with anesthesia

    Time frame: Determined at the end of all treatment sessions, for 4 weeks.

    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.

  2. Injectable anesthetic requirement

    Time frame: If pain persisted after this second application, then an anesthesia infiltration/block was performed, for 4 weeks.

    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.

  3. Adverse Events

    Time frame: Determined when each patient returned for the next treatment session, for 4 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Franciscan University Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 22, 2013
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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