Local AnesthesiaNCT01860235
EMLA Topical Anesthetic During Scaling and Root Planing
A study testing EMLA, Injectable anesthesia and 2% Benzocaine in people with Local Anesthesia and Pain, Postoperative, run by Franciscan University Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Local Anesthesia, Pain, Postoperative, Self-Perception
- What is being tested?
- EMLA, Injectable anesthesia and 2% Benzocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Topical Intrapocket Anesthesia With Prilocaine and Lidocaine as Alternative to Injectable Anesthesia During Scaling and Root Planing - A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Local Anesthesia, Pain, Postoperative, Self-Perception
- Being tested
- EMLA, Injectable anesthesia, 2% Benzocaine, Placebo
- Keywords
- Local anesthesia, Pain measurement, Pain perception, Dental anesthesia, Root planing
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLADrug
Also called EMLA®, AstraZeneca, Cotia, SP, Brazil
% eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine
Injectable anesthesiaDrug
Also called Alphacaine®, DFL, Rio de Janeiro, Brazil
Injectable anesthesia 2% lidocaine with epinephrine 1:100.000
2% BenzocaineDrug
Also called Benzotop ®, DFL, Rio de Janeiro, Brazil
Topical anesthetic - 200mg/g of 2% benzocaine
PlaceboDrug
Also called manipulated topical anesthetics
Manipulated with the same appearance and viscosity of topical anesthetics mentioned above
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Determined at the end of all treatment sessions, for 4 weeks.
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.
Measured: If pain persisted after this second application, then an anesthesia infiltration/block was performed, for 4 weeks.
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.
Measured: Determined when each patient returned for the next treatment session, for 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franciscan University Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Pippi Antoniazzi, Franciscan University Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860235
- Sponsor's protocol ID
- EMLA2012
- Status last verified
- May 2013
- First submitted
- 8 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Intrapocket Anesthesia With Prilocaine and Lidocaine as Alternative to Injectable Anesthesia During Scaling and Root Planing - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01860235
- Acronym / sponsor ID
- EMLA2012
- Conditions
- Local Anesthesia, Pain, Postoperative, Self-Perception
- Keywords
- Local anesthesia, Pain measurement, Pain perception, Dental anesthesia, Root planing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Franciscan University CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sextant 1 | Experimental | Drug: EMLATreatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (EMLA) |
| sextant 2 | Active comparator | Drug: Injectable anesthesiaTreatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Injectable anesthesia) |
| sextant 3 | Active comparator | Drug: 2% BenzocaineTreatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (2% Benzocaine) |
| sextant 4 | Placebo comparator | Drug: PlaceboTreatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMLAAlso: EMLA®, AstraZeneca, Cotia, SP, Brazil% eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine | Drug | sextant 1 |
| Injectable anesthesiaAlso: Alphacaine®, DFL, Rio de Janeiro, BrazilInjectable anesthesia 2% lidocaine with epinephrine 1:100.000 | Drug | sextant 2 |
| 2% BenzocaineAlso: Benzotop ®, DFL, Rio de Janeiro, BrazilTopical anesthetic - 200mg/g of 2% benzocaine | Drug | sextant 3 |
| PlaceboAlso: manipulated topical anestheticsManipulated with the same appearance and viscosity of topical anesthetics mentioned above | Drug | sextant 4 |
Primary outcome
Pain and discomfort
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.
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).
3 secondary outcomes
Patient satisfaction with anesthesia
Time frame: Determined at the end of all treatment sessions, for 4 weeks.
Injectable anesthetic requirement
Time frame: If pain persisted after this second application, then an anesthesia infiltration/block was performed, for 4 weeks.
Adverse Events
Time frame: Determined when each patient returned for the next treatment session, for 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EMLA, Injectable anesthesia and 2% Benzocaine in people with Local Anesthesia and Pain, Postoperative, run by Franciscan University Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and discomfort (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013.