EMLA Topical Anesthetic During Scaling and Root Planing

NCT01860235 | Completed

• 1 other identifier: EMLA2012
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Local Anesthesia; Pain, Postoperative; Self-Perception

Keywords

Local anesthesia; Pain measurement; Pain perception; Dental anesthesia; Root planing

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Patient satisfaction with anesthesia

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

• Injectable anesthetic requirement

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

• Adverse Events

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

Study Arms (4)

sextant 1

EXPERIMENTAL

Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (EMLA)

Drug: EMLA

sextant 2

ACTIVE COMPARATOR

Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Injectable anesthesia)

Drug: Injectable anesthesia

sextant 3

ACTIVE COMPARATOR

Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (2% Benzocaine)

Drug: 2% Benzocaine

sextant 4

PLACEBO COMPARATOR

Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Placebo)

Drug: Placebo

Interventions

EMLA DRUG

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

Also known as: EMLA®, AstraZeneca, Cotia, SP, Brazil

sextant 1

Injectable anesthesia DRUG

Injectable anesthesia 2% lidocaine with epinephrine 1:100.000

Also known as: Alphacaine®, DFL, Rio de Janeiro, Brazil

sextant 2

2% Benzocaine DRUG

Topical anesthetic - 200mg/g of 2% benzocaine

Also known as: Benzotop ®, DFL, Rio de Janeiro, Brazil

sextant 3

Placebo DRUG

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

Also known as: manipulated topical anesthetics

sextant 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franciscan University Center: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine, Prilocaine Drug Combination; Benzocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Topical intrapocket anesthesia with prilocaine and lidocaine as an alternative to injectable anesthesia during scaling and root planing - A randomized clinical trial

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 22, 2013
• Study Start: June 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 22, 2013

Record last verified: 2013-05