EMLA Topical Anesthetic During Scaling and Root Planing

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860235
• Other study ID #: EMLA2012
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: May 18, 2013
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: Franciscan University Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Local Anesthesia
• Pain, Postoperative
• Self-Perception

Intervention

Drug:
• EMLA
% eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine
• Injectable anesthesia
Injectable anesthesia 2% lidocaine with epinephrine 1:100.000
• 2% Benzocaine
Topical anesthetic - 200mg/g of 2% benzocaine
• Placebo
Manipulated with the same appearance and viscosity of topical anesthetics mentioned above

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Franciscan University Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No