DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 anesthesia

Injectable 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017