Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT06992193
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2025-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Digital Anesthesia Versus Conventional Techniques in Reducing Pain and Anxiety in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-24', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-24', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wong-Baker FACES pain scores at three time points', 'timeFrame': 'Time Frame: Immediately before needle insertion, during anesthetic delivery at the time of the procedure, and during dental procedure (Day 1)', 'description': 'Pain was assessed using the Wong-Baker FACES Pain Rating Scale at three stages: (1) needle insertion, (2) anesthetic delivery, and (3) during dental treatment. Scores range from 0 (no hurt) to 10 (hurts worst).'}], 'secondaryOutcomes': [{'measure': 'Change in MCDAS anxiety scores before and after treatment', 'timeFrame': 'Day 1 - immediately before and after dental procedure', 'description': 'Dental anxiety was measured using the Modified Child Dental Anxiety Scale (MCDAS) immediately before and after the procedure. The scale ranges from 8 to 40, with higher scores indicating greater anxiety.'}, {'measure': 'FLACC behavioral pain scores during anesthesia', 'timeFrame': 'Periprocedural (Day 1) - during anesthetic injection phase', 'description': 'Behavioral responses were recorded using the FLACC scale, which evaluates Face, Legs, Activity, Cry, and Consolability. Each domain is scored from 0-2, for a total range of 0-10.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Anxiety', 'Pain Management', 'Intraosseous anesthesia', 'Local Anesthesia'], 'conditions': ['Pain in Pediatric Dentistry', 'Dental Anxiety']}, 'referencesModule': {'references': [{'pmid': '41137566', 'type': 'DERIVED', 'citation': 'Atesci AA, Korkut Isik B, Yilmaz DO, Gergit B, Kilic MC, Oncag RO. Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Pediatric Dentistry? Int J Paediatr Dent. 2025 Oct 25. doi: 10.1111/ipd.70048. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter randomized controlled clinical trial was conducted to evaluate the effectiveness of digital anesthesia using a computer-controlled intraosseous system (SleeperOne 5®) compared to traditional local anesthesia techniques (infiltration and mandibular block) in paediatric dental patients.\n\nA total of 79 children aged 6-12 years were randomly assigned to one of three groups. Pain perception, anxiety levels, and behavioral responses were assessed using validated tools including the Wong-Baker FACES Pain Scale, the Modified Child Dental Anxiety Scale (MCDAS), and the FLACC behavioral scale.\n\nThe study aimed to determine whether digital anesthesia could provide a less painful and less anxiety-inducing experience for children during dental treatment. Findings may support broader clinical adoption of computer-assisted anesthetic delivery in paediatric dentistry.', 'detailedDescription': 'This randomized controlled clinical trial was designed to compare the effects of digital anesthesia, conventional infiltration, and mandibular block techniques on pain perception, anxiety levels, and behavioral responses in paediatric dental patients. The study was conducted at two academic institutions: Ege University and Beykent University in Turkey.\n\nA total of 79 healthy, cooperative children aged 6 to 12 years requiring restorative, endodontic, or extraction procedures on primary teeth were randomly assigned to one of three anesthesia groups: digital anesthesia (n=34), infiltration (n=22), and mandibular block (n=23). Randomization was performed using a computer-generated sequence, and pain, anxiety, and behavior were assessed by a blinded, calibrated examiner.\n\nThe digital anesthesia group received intraosseous injection via the SleeperOne 5® system (using 4% articaine with 1:200,000 epinephrine). The infiltration and block groups received 2% lidocaine with 1:100,000 epinephrine using conventional syringes. All patients received topical 20% benzocaine gel prior to injection.\n\nPain was assessed at three time points (needle insertion, anesthetic delivery, and treatment) using the Wong-Baker FACES scale. Dental anxiety was measured pre- and post-treatment using the Modified Child Dental Anxiety Scale (MCDAS), and behavioral responses were recorded during treatment using the FLACC scale.\n\nThe aim was to evaluate whether digital anesthesia provides superior outcomes in terms of comfort, reduced fear, and improved cooperation in the paediatric dental setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6 to 12 years\n* ASA I or II health status\n* Cooperative behavior (Frankl score 3-4 or Venham score 0-2)\n* Indicated for restorative, endodontic, or extraction treatment on primary teeth\n* No prior local anesthesia experience during the previous 6 months\n\nExclusion Criteria:\n\n* Presence of systemic or neurological diseases\n* Use of analgesics within 48 hours before the procedure\n* Uncooperative behavior (Frankl score 1-2 or Venham score \\>2)\n* Incomplete cooperation during the procedure\n* Allergy to articaine, lidocaine, or epinephrine'}, 'identificationModule': {'nctId': 'NCT06992193', 'acronym': 'DAPAED', 'briefTitle': 'Effectiveness of Digital Anesthesia Versus Conventional Techniques in Reducing Pain and Anxiety in Children', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Paediatric Dentistry?', 'orgStudyIdInfo': {'id': 'Alp'}, 'secondaryIdInfos': [{'id': '24-11/83', 'type': 'OTHER_GRANT', 'domain': 'Ethics Committee on Human Research, Ege University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Anesthesia', 'description': 'Children receiving intraosseous local anesthesia via a computer-controlled delivery system (SleeperOne 5®) using 4% articaine with 1:200,000 epinephrine.', 'interventionNames': ['Device: Digital Anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infiltration Anesthesia', 'description': 'Children receiving traditional infiltration anesthesia using 2% lidocaine with 1:100,000 epinephrine via standard dental syringe.', 'interventionNames': ['Drug: Infiltration Anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mandibular Block Anesthesia', 'description': 'Children receiving conventional inferior alveolar nerve block with 2% lidocaine and 1:100,000 epinephrine using a long dental needle.', 'interventionNames': ['Drug: Mandibular Block']}], 'interventions': [{'name': 'Digital Anesthesia', 'type': 'DEVICE', 'otherNames': ['SleeperOne 5'], 'description': 'Computer-controlled intraosseous anesthesia system (Dental Hi Tec, France) used to deliver 1.3 mL of 4% articaine with 1:200,000 epinephrine in two stages: gingival and intraosseous injection. The system provides consistent flow and reduced pain perception in children.', 'armGroupLabels': ['Digital Anesthesia']}, {'name': 'Infiltration Anesthesia', 'type': 'DRUG', 'otherNames': ['Lidocaine hydrochloride 2% with epinephrine 1:100,000'], 'description': '1 mL of 2% lidocaine with epinephrine was delivered via buccal infiltration using a conventional aspirating syringe and 27-gauge short needle. Topical benzocaine gel was applied for 30 seconds prior to injection.', 'armGroupLabels': ['Infiltration Anesthesia']}, {'name': 'Mandibular Block', 'type': 'DRUG', 'otherNames': ['IANB'], 'description': '1 mL of lidocaine was administered using the inferior alveolar nerve block technique via a conventional dental syringe and 27-gauge long needle. Negative aspiration was confirmed prior to slow deposition.', 'armGroupLabels': ['Mandibular Block Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'İstanbul Beykent University Faculty of Dentistry Department of Pediatric Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Faculty of Dentistry Department of Pediatric Dentistry', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD', 'investigatorFullName': 'Alp Abidin Ateşçi', 'investigatorAffiliation': 'Ege University'}}}}