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EMLA Topical Anesthetic During Scaling and Root Planing

Primary Purpose

Local Anesthesia, Pain, Postoperative, Self-Perception

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EMLA
Injectable anesthesia
2% Benzocaine
Placebo
Sponsored by
Franciscan University Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Local Anesthesia focused on measuring Local anesthesia, Pain measurement, Pain perception, Dental anesthesia, Root planing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    sextant 1

    sextant 2

    sextant 3

    sextant 4

    Arm Description

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

    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)

    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)

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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    May 8, 2013
    Last Updated
    May 18, 2013
    Sponsor
    Franciscan University Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01860235
    Brief Title
    EMLA Topical Anesthetic During Scaling and Root Planing
    Official Title
    Topical Intrapocket Anesthesia With Prilocaine and Lidocaine as Alternative to Injectable Anesthesia During Scaling and Root Planing - A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Franciscan University Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Local Anesthesia, Pain, Postoperative, Self-Perception
    Keywords
    Local anesthesia, Pain measurement, Pain perception, Dental anesthesia, Root planing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sextant 1
    Arm Type
    Experimental
    Arm Description
    Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (EMLA)
    Arm Title
    sextant 2
    Arm Type
    Active Comparator
    Arm Description
    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)
    Arm Title
    sextant 3
    Arm Type
    Active Comparator
    Arm Description
    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)
    Arm Title
    sextant 4
    Arm Type
    Placebo Comparator
    Arm Description
    Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Placebo)
    Intervention Type
    Drug
    Intervention Name(s)
    EMLA
    Other Intervention Name(s)
    EMLA®, AstraZeneca, Cotia, SP, Brazil
    Intervention Description
    % eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine
    Intervention Type
    Drug
    Intervention Name(s)
    Injectable anesthesia
    Other Intervention Name(s)
    Alphacaine®, DFL, Rio de Janeiro, Brazil
    Intervention Description
    Injectable anesthesia 2% lidocaine with epinephrine 1:100.000
    Intervention Type
    Drug
    Intervention Name(s)
    2% Benzocaine
    Other Intervention Name(s)
    Benzotop ®, DFL, Rio de Janeiro, Brazil
    Intervention Description
    Topical anesthetic - 200mg/g of 2% benzocaine
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    manipulated topical anesthetics
    Intervention Description
    Manipulated with the same appearance and viscosity of topical anesthetics mentioned above
    Primary Outcome Measure Information:
    Title
    Pain and discomfort
    Description
    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).
    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.
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction with anesthesia
    Description
    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.
    Time Frame
    Determined at the end of all treatment sessions, for 4 weeks.
    Title
    Injectable anesthetic requirement
    Description
    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.
    Time Frame
    If pain persisted after this second application, then an anesthesia infiltration/block was performed, for 4 weeks.
    Title
    Adverse Events
    Description
    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.
    Time Frame
    Determined when each patient returned for the next treatment session, for 4 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

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    EMLA Topical Anesthetic During Scaling and Root Planing

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