Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-08 @ 9:15 PM
Study NCT ID:
NCT03839134
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2019-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-02-10', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain of needle penetration of buccal LA injection', 'timeFrame': '1-2 seconds after mucosal penetration', 'description': 'The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.'}, {'measure': 'Pain of anesthesia delivery during buccal LA infiltration', 'timeFrame': '30 seconds after LA solution delivery', 'description': 'The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.'}, {'measure': 'Pain of needle penetration of palatal LA injection', 'timeFrame': '1-2 seconds after mucosal penetration', 'description': 'The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.'}, {'measure': 'Pain of anesthesia delivery during palatal LA infiltration', 'timeFrame': '30 seconds after LA solution delivery', 'description': 'The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.'}, {'measure': 'Pain of needle penetration of IAN block LA injection', 'timeFrame': '1-2 seconds after mucosal penetration', 'description': 'The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.'}, {'measure': 'Pain of anesthesia delivery during IAN block LA injection', 'timeFrame': '30 seconds after LA solution delivery', 'description': 'The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthetics, Local']}, 'descriptionModule': {'briefSummary': 'The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. The primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques (infiltration and block anesthesia).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status class I\n* Planned for multiple dental treatments in the maxilla and mandible bilaterally\n\nExclusion Criteria:\n\n* Patients \\<18 years old\n* Pregnant ladies\n* Smokers and alcoholics\n* Patients on medications\n* Drug abusers\n* Never received dental treatment under local anesthesia before\n* Patients with an acute infection with or without fever\n* Patients with preoperative pain'}, 'identificationModule': {'nctId': 'NCT03839134', 'briefTitle': 'The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Colleges of Dentistry and Pharmacy'}, 'officialTitle': 'The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial.', 'orgStudyIdInfo': {'id': 'FRP/2018/286'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain of buccal injection with DentalVibe®', 'description': 'DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) buccal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.', 'interventionNames': ['Device: DentalVibe® Comfort Injection System', 'Drug: Lidocaine Epinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain of buccal injection without DentalVibe®', 'description': 'Local anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.', 'interventionNames': ['Drug: Lidocaine Epinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Pain of palatal injection with DentalVibe®', 'description': 'DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) palatal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.', 'interventionNames': ['Device: DentalVibe® Comfort Injection System', 'Drug: Lidocaine Epinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain of palatal injection without DentalVibe®', 'description': 'Local anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.', 'interventionNames': ['Drug: Lidocaine Epinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Pain of block injection with DentalVibe®', 'description': 'DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) injection for inferior alveolar nerve (IAN) block. The LA to be used is Lidocaine 2% with Epinephrine dental injection.', 'interventionNames': ['Device: DentalVibe® Comfort Injection System', 'Drug: Lidocaine Epinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain of block injection without DentalVibe®', 'description': 'Local anesthesia (LA) injection for inferior alveolar nerve (IAN) block using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.', 'interventionNames': ['Drug: Lidocaine Epinephrine']}], 'interventions': [{'name': 'DentalVibe® Comfort Injection System', 'type': 'DEVICE', 'otherNames': ['DentalVibe'], 'description': 'Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.', 'armGroupLabels': ['Pain of block injection with DentalVibe®', 'Pain of buccal injection with DentalVibe®', 'Pain of palatal injection with DentalVibe®']}, {'name': 'Lidocaine Epinephrine', 'type': 'DRUG', 'otherNames': ['Xylocaine 2% with Epinephrine'], 'description': 'Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).', 'armGroupLabels': ['Pain of block injection with DentalVibe®', 'Pain of block injection without DentalVibe®', 'Pain of buccal injection with DentalVibe®', 'Pain of buccal injection without DentalVibe®', 'Pain of palatal injection with DentalVibe®', 'Pain of palatal injection without DentalVibe®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12734', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Riyadh Elm University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': "Ra'ed G Salma", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riyadh Elm University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riyadh Colleges of Dentistry and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': "Ra'ed Salma", 'investigatorAffiliation': 'Riyadh Colleges of Dentistry and Pharmacy'}}}}