EMLA Topical Anesthetic During Scaling and Root Planing
Information source: Franciscan University Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Local Anesthesia; Pain, Postoperative; Self-Perception
Intervention: EMLA (Drug); Injectable anesthesia (Drug); 2% Benzocaine (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Franciscan University Center
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.
Clinical Details
Official title: Topical Intrapocket Anesthesia With Prilocaine and Lidocaine as Alternative to Injectable Anesthesia During Scaling and Root Planing - A Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain and discomfort
Secondary outcome: Patient satisfaction with anesthesiaInjectable anesthetic requirement Adverse Events
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: June 2010
Last updated: May 18, 2013
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