Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05908305
Status:
UNKNOWN
Last Update Posted:
2023-06-18
First Post:
2022-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Tramadol Addiction On Dental Anesthesia Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002355', 'term': 'Carticaine'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D000766', 'term': 'Anesthesia, Dental'}, {'id': 'D008619', 'term': 'Mepivacaine'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'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'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Dentists providing dental care participating in the study are masked.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Assessing local dental anesthesia success while performing different dental care among Algerian males addicted or not addicted to tramadol.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2022-12-04', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect', 'timeFrame': '3 months', 'description': 'The quantity (ml) of dental anesthesia used to perform dental and oral surgery procedure among tramadol addicted and non-addicted patients will be mesured to investigate the difference.'}, {'measure': 'To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures', 'timeFrame': '3 months', 'description': 'Among addicted and non-addicted patients, the number of carpules of dental anesthesia necessary for total analgesic effect will be determined.'}], 'secondaryOutcomes': [{'measure': 'To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.', 'timeFrame': '3 months', 'description': 'As our hypothesis suggested that tramadol addiction cause dental anesthesia failure, we would like to calculate the dose and number of months of tramadol consumption necessary to provok dental anesthesia failure as an addiction complication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tramadol', 'Addiction', 'Local Anesthesia', 'Dentistry', 'Carpule'], 'conditions': ['Dental Pain and Sensation Disorder', 'Anesthesia, Local', 'Addiction, Opioid']}, 'referencesModule': {'references': [{'pmid': '24346042', 'type': 'BACKGROUND', 'citation': 'Carnaval TG, Sampaio RM, Lanfredi CB, Borsatti MA, Adde CA. Effects of opioids on local anesthesia in the rat: a codeine and tramadol study. Braz Oral Res. 2013 Nov-Dec;27(6):455-62. doi: 10.1590/S1806-83242013000600003.'}, {'pmid': '15804720', 'type': 'BACKGROUND', 'citation': 'Guven M, Mert T, Gunay I. Effects of tramadol on nerve action potentials in rat: comparisons with benzocaine and lidocaine. Int J Neurosci. 2005 Mar;115(3):339-49. doi: 10.1080/00207450590520948.'}, {'pmid': '32467795', 'type': 'BACKGROUND', 'citation': 'Premnath S, Alalshaikh G, Alfotawi R, Philip M. The Association Between Coffee Consumption and Local Anesthesia Failure: Social Beliefs and Scientific Evidence. Cureus. 2020 Apr 24;12(4):e7820. doi: 10.7759/cureus.7820.'}, {'pmid': '20478804', 'type': 'BACKGROUND', 'citation': 'Fung EY, Giannini PJ. Implications of drug dependence on dental patient management. Gen Dent. 2010 May-Jun;58(3):236-41; quiz 242-3.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to investigate and to find a correlation between tramadol addiction misuse among Algerian males and Dental Local Anesthesia success while performing dental care and oral surgeries.', 'detailedDescription': "Local anesthesia is by far the most important part of pain control in dentistry, it is the cornerstone that makes many dental procedures possible, not only for the patient but also for the dentist and dental hygienists. Since the pain and the dentist are almost synonymous for the patient, this makes dental anesthesia the most widely administered drugs in the dental clinics. Hence, the failure of local anesthesia in oral medicine presents an undesirable outcome both for the patient and for the practitioner.\n\nThe intraoperative pain being prevented by the administration of a local anesthesia must be followed by the management of the postoperative pain which can be often intense and thus requiring drugs administration. These drugs could be nonopioid or opioid analgesics which are also frequently used in general medicine as Tramadol.\n\nTramadol is 2-(dimethyl amino)-methyl)-1-(3'-methoxyphenyl) cyclohexanol hydrochloride. It is 4-phenyl-piperidine analogue of the opioid drug codeine. It is generally well tolerated with few and rare side effects. Moreover, comparative studies have mostly shown that Tramadol is more effective than NSAIDs for post operative pain control. However, its misuse is increasingly growing and has become obvious in Algeria.\n\nTramadol addiction has become very frequent, and its unjustified use is expanding. This might be attributed to the fragility of the health system and the replacement of the qualified pharmacists by non-qualified helpers or assistants."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only males will be recruited since this topic is somehow stigma in Algeria. Drugs abusive use in Algeria is found among males and females but considered for religious and society related reasons a stigma.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males\n* ≥18 years old \\<65\n* Without comorbid conditions (Hypertension, diabetes, Asthma etc..)\n* Tramadol addicted (regular tramadol user)\n* Only tramadol addicted, if any other drugs are regularly consumed, the patient is excluded.\n\nExclusion Criteria:\n\n* Females\n* ˂ 18 years old\n* With comorbid conditions (HTN, diabetes, epilepsy etc..)\n* ≥ 65 years old men.\n* Not addicted to tramadol or addicted to other drugs with it.'}, 'identificationModule': {'nctId': 'NCT05908305', 'briefTitle': 'Impact of Tramadol Addiction On Dental Anesthesia Success', 'organization': {'class': 'OTHER', 'fullName': 'University of Algiers'}, 'officialTitle': 'Study of Tramadol Addiction Impact on Dental Anesthesia Succes.', 'orgStudyIdInfo': {'id': 'Tramadol Addict Impact On Dent'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol Addicted Patients', 'description': 'It represents the group of tramadol addicted patients seeking dental care that require dental anesthesia.', 'interventionNames': ['Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non addicted patients', 'description': 'The group of patients requiring dental care with local anesthesia and who are not addicted to tramadol.', 'interventionNames': ['Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia']}], 'interventions': [{'name': 'articaine@ (4% 1:100000 epinephrine) dental anesthesia', 'type': 'DRUG', 'otherNames': ['mepivacaine@ (2%@ 1:100000 epinephrine) dental anesthesia'], 'description': 'Administration, calculation and adjustment of dental local anesthesia doses.', 'armGroupLabels': ['Non addicted patients', 'Tramadol Addicted Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohammed Amir Rais, DMD', 'role': 'CONTACT', 'email': 'raismohammedamir@gmail.com', 'phone': '+213696988763'}, {'name': 'Mohammed Amir Rais', 'role': 'CONTACT', 'email': 'raismohammedamir@gmail.com', 'phone': '+213696988763'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Algiers', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammed Amir Rais', 'investigatorAffiliation': 'University of Algiers'}}}}