Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-29 @ 5:11 AM
Study NCT ID:
NCT04392804
Status:
UNKNOWN
Last Update Posted:
2023-06-15
First Post:
2020-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-11', 'studyFirstSubmitDate': '2020-05-09', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of success anesthesia', 'timeFrame': '1 day', 'description': 'The number of success anesthesia'}, {'measure': 'Duration of soft tissue anesthesia', 'timeFrame': '1 day', 'description': 'Time from completion of the injection until patient start filling discomfort/pain on pinprick test, measured in minutes.'}, {'measure': 'Width of the anesthetic field', 'timeFrame': '1 day', 'description': 'Distance between two needles that were not causing pain on pinprick test, measured in millimeters.'}, {'measure': 'Onset time for anesthesia', 'timeFrame': '1 day', 'description': 'Time started after completion of the injection until profound anesthesia is establish, measured in seconds.'}, {'measure': 'Rate of pain during anesthetic delivery by VAS', 'timeFrame': '1 day', 'description': 'Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is labeled for the minimum feel of pain or no pain, and 100 is labeled for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.'}, {'measure': 'Rate of pain during scaling and root planing by VAS', 'timeFrame': '1 day', 'description': 'Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is score for the minimum feel of pain or no pain, and 100 is score for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.'}, {'measure': 'Presence of side effects', 'timeFrame': '1 day', 'description': 'Record any side effects.'}, {'measure': 'Analgesic medication consumption', 'timeFrame': '1 day', 'description': 'Record number of analgesic medications.'}, {'measure': 'Wich day analgesic medication is used', 'timeFrame': '7 days', 'description': 'Wich day from intervention a analgesic medication is used'}], 'secondaryOutcomes': [{'measure': 'Pocket probing depths', 'timeFrame': '1 day', 'description': 'Measuring the pocket probing depths by periodontal probe, in milimeteres.'}, {'measure': 'Gingival margin level', 'timeFrame': '1 day', 'description': 'Measuring the gingival margin level by periodontal probe, in milimeteres.'}, {'measure': 'Clinical attachment level', 'timeFrame': '1 day', 'description': 'Measuring the clinical attachment level by periodontal probe, measured in milimeters.'}, {'measure': 'Percentage of bleeding sites', 'timeFrame': '1 day', 'description': 'The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage.'}, {'measure': 'Percentage of plaque index', 'timeFrame': '1 day', 'description': 'The number of sites where plaque is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the plaque index as a percentage.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intraseptal anesthesia', 'ISA', 'CCLADS'], 'conditions': ['Anesthesia, Local', 'Periodontitis']}, 'referencesModule': {'references': [{'pmid': '37644233', 'type': 'DERIVED', 'citation': 'Djoric J, Djinic Krasavcevic A, Barac M, Kuzmanovic Pficer J, Brkovic B, Nikolic-Jakoba N. Patient discomfort and intensity of intraseptal anesthesia of computer-controlled articaine/epinephrine delivery for scaling and root planing. Clin Oral Investig. 2023 Oct;27(10):6221-6234. doi: 10.1007/s00784-023-05238-1. Epub 2023 Aug 29.'}, {'pmid': '36746819', 'type': 'DERIVED', 'citation': 'Djoric J, Djinic Krasavcevic A, Barac M, Kuzmanovic Pficer J, Brkovic B, Nikolic-Jakoba N. Efficacy of intraseptal anesthesia obtained by computer-controlled articaine with epinephrine delivery in scaling and root planing. Clin Oral Investig. 2023 Jun;27(6):2913-2922. doi: 10.1007/s00784-023-04889-4. Epub 2023 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'The aims of our study were to evaluate the clinical anesthetic parameters of the intraseptal anesthesia (ISA), achieved by computer-controlled local anesthetic delivery system CCLADS, for scaling and root planing, as a primary outcome of the study. In addition, as secondary outcome of the study the impact of destruction of the periodontal supporting tissues on clinical anesthetic parameters of the ISA achieved by 4% articaine with 1:100,000 epinephrine, using CCLAD system.', 'detailedDescription': 'After including the patients into the study, patient needs to sign a written consent. After that, the next appointment will be scheduled. On the next appointment, each patient included in this study will undergo ultrasound cleaning and receive guidance for adequate everyday oral hygiene. The next appointment, after 10 days will be scaling and root planing for selected periodontal pockets. Because it is painful treatment, anesthesia is needed to be administrated. Patients will be split into three groups by picking cards, for receiving different doses of 4% articaine with 1:100,000 epinephrine ORABLOC® (40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy) in each group. Doses will be 0.1 ml, 0.2 ml, and 0.3 ml of 4% articaine with epinephrine for one appointment scaling and root planing. Anesthesia will be obtained by CCLADS device Anaject® (Septodont, Sallanches, Franc). The Intraseptal anesthesia (ISA) will be the method of administrating the anesthesia. Parameters of the device will be a mode with constant pressure, injection speed - mode LOW 0.005 ml/s. Time for application will depend on the dose, and it will be 20 s for 0.1 ml, 40 s for 0.2 ml, and 60 s for 0.3 ml.\n\nParameters of local anesthesia will be recorded by the pin-prick test. The pain will be rated by the visual-analogue scale (VAS). The pain will be rated immediately upon termination of the local anesthetic delivery and during the scaling and root planing.\n\nPatients will be followed up the next day for local side effects and their need for analgesic medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Systemically healthy periodontitis patients having the indication for scaling and root planing.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years\n* confirmed diagnosis of periodontitis\n* presence of minimum 20 teeth\n* absence of decay\n* preserved tooth vitality\n* good systematic health\n\nExclusion Criteria:\n\n* allergy to articaine with 1: 100,000 epinephrine\n* pregnancy\n* lactation\n* medication uptake that affects the periodontal supporting tissues\n* acute pain, swelling, presence of gingival lesions'}, 'identificationModule': {'nctId': 'NCT04392804', 'acronym': 'EISAAECCLAD', 'briefTitle': 'Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'Efficacy of Intraseptal Anesthesia Obtained by 4 % Articaine With 1:100,000 Epinephrine Achieved by Computer-controlled Delivery System', 'orgStudyIdInfo': {'id': 'UBelgrade 36/8'}}, 'armsInterventionsModule': {'armGroups': [{'label': '0.1 ml 4% articaine', 'description': 'single dose of 0.1 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing', 'interventionNames': ['Procedure: scaling and root planing']}, {'label': '0.2 ml 4% articaine', 'description': 'single dose of 0.2 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing', 'interventionNames': ['Procedure: scaling and root planing']}, {'label': '0.3 ml 4% articaine', 'description': 'single dose of 0.3 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing', 'interventionNames': ['Procedure: scaling and root planing']}], 'interventions': [{'name': 'scaling and root planing', 'type': 'PROCEDURE', 'description': 'one appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution', 'armGroupLabels': ['0.1 ml 4% articaine', '0.2 ml 4% articaine', '0.3 ml 4% articaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no, for now, need to review conditions of terms of sharing the information'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, DDS, MSc, PhD', 'investigatorFullName': 'Natasa Nikolic Jakoba', 'investigatorAffiliation': 'University of Belgrade'}}}}