Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-04-15 @ 9:20 AM
Study NCT ID:
NCT01860235
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2013-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMLA Topical Anesthetic During Scaling and Root Planing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077442', 'term': 'Lidocaine, Prilocaine Drug Combination'}, {'id': 'D001566', 'term': 'Benzocaine'}], 'ancestors': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-18', 'studyFirstSubmitDate': '2013-05-08', 'studyFirstSubmitQcDate': '2013-05-18', 'lastUpdatePostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain and discomfort', 'timeFrame': '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.', '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).'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction with anesthesia', 'timeFrame': 'Determined at the end of all treatment sessions, for 4 weeks.', '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.'}, {'measure': 'Injectable anesthetic requirement', 'timeFrame': 'If pain persisted after this second application, then an anesthesia infiltration/block was performed, for 4 weeks.', '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.'}, {'measure': 'Adverse Events', 'timeFrame': 'Determined when each patient returned for the next treatment session, for 4 weeks.', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Local anesthesia', 'Pain measurement', 'Pain perception', 'Dental anesthesia', 'Root planing'], 'conditions': ['Local Anesthesia', 'Pain, Postoperative', 'Self-Perception']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eligible individuals for the study were selected from those requiring SRP with at least 2 experimental teeth in four of the six sextants.\n* each experimental teeth had to present ≥ 1 site with probing depth ≥ 5 mm associated with BP after treatment of gingivitis (without marginal bleeding).\n* 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).\n\nExclusion criteria:\n\n* patients that related allergy history or sensitivity reaction to any used amide or ester anesthetics form,\n* who received anesthesia or sedation 12 hours before SRP,\n* who presented ulcerated lesions or abscesses in the oral cavity,\n* who presented oral pathologies with immediate surgical,\n* who had prior abuse alcohol history, pregnant women,\n* who presented uncontrolled hypertension or\n* who had participated in a clinical trial of investigational drug before four months from the beginning of this study.'}, 'identificationModule': {'nctId': 'NCT01860235', 'briefTitle': 'EMLA Topical Anesthetic During Scaling and Root Planing', 'organization': {'class': 'OTHER', 'fullName': 'Franciscan University Center'}, 'officialTitle': 'Topical Intrapocket Anesthesia With Prilocaine and Lidocaine as Alternative to Injectable Anesthesia During Scaling and Root Planing - A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'EMLA2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sextant 1', '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)', 'interventionNames': ['Drug: EMLA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sextant 2', '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)', 'interventionNames': ['Drug: Injectable anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sextant 3', '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)', 'interventionNames': ['Drug: 2% Benzocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sextant 4', '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)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EMLA', 'type': 'DRUG', 'otherNames': ['EMLA®, AstraZeneca, Cotia, SP, Brazil'], 'description': '% eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine', 'armGroupLabels': ['sextant 1']}, {'name': 'Injectable anesthesia', 'type': 'DRUG', 'otherNames': ['Alphacaine®, DFL, Rio de Janeiro, Brazil'], 'description': 'Injectable anesthesia 2% lidocaine with epinephrine 1:100.000', 'armGroupLabels': ['sextant 2']}, {'name': '2% Benzocaine', 'type': 'DRUG', 'otherNames': ['Benzotop ®, DFL, Rio de Janeiro, Brazil'], 'description': 'Topical anesthetic - 200mg/g of 2% benzocaine', 'armGroupLabels': ['sextant 3']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['manipulated topical anesthetics'], 'description': 'Manipulated with the same appearance and viscosity of topical anesthetics mentioned above', 'armGroupLabels': ['sextant 4']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Franciscan University Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Topical intrapocket anesthesia with prilocaine and lidocaine as an alternative to injectable anesthesia during scaling and root planing - A randomized clinical trial', 'investigatorFullName': 'Raquel Pippi Antoniazzi', 'investigatorAffiliation': 'Franciscan University Center'}}}}