Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-28 @ 12:29 PM
Study NCT ID:
NCT05418504
Status:
UNKNOWN
Last Update Posted:
2022-06-16
First Post:
2022-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000766', 'term': 'Anesthesia, Dental'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The recruited participants will then be divided into 2 groups the control group represented by dental patients who are not a tramadol addict \\& The study group with patients seeking dental service but also are tramadol addict.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anesthesia dose', 'timeFrame': '3 months', 'description': 'Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental anesthesia', 'tramadol'], 'conditions': ['Dental Procedure']}, 'descriptionModule': {'briefSummary': 'Dental anesthesia is considered by far one of the main procedures in dentistry; the performance of a good dental anesthesia with a correct technique is paramount in controlling pain, facilitating the work of the dentist and gaining the confidence and cooperation of the patient\n\nTramadol is an FDA-approved medication for pain relief indicated mainly for moderate to severe pain, it is an opioid with 6 hours Half-Life and different dosages as 50mg, 100mg, 200mg and 300mg. Due to possible abuse and addiction potential, limitations to its use should be for pain that is refractive to other pain medication, such as non-opioid pain medication, unfortunately, the almost non-existent of censorship in Algeria and the disorderly framing made the obtain of tramadol as a medicine very easy which has led to a very alarming abuse of this drug', 'detailedDescription': 'Tramadol is an FDA-approved medication for pain relief indicated mainly for moderate to severe pain, it is an opioid with 6 hours Half-Life and different dosages as 50mg, 100mg, 200mg and 300mg. Due to possible abuse and addiction potential, limitations to its use should be for pain that is refractive to other pain medication, such as non-opioid pain medication, unfortunately, the almost non-existent of censorship in Algeria and the disorderly framing made the obtain of tramadol as a medicine very easy which has led to a very alarming abuse of this drug Meanwhile, apart from the systemic manifestations resulting from the abusive consumption of tramadol, it has become very clear that this opioid has a negative impact on the rapid and sufficient analgesic effect of dental anesthesia, it has been noticed that the anesthesia does not hold easily and the number of cartridges needed is increased, and therefore, a very particular attention must be attributed to the organization and control of its obtaining in order to limit its addiction in young people, an improvement of the care of patients must be offered according to the parameters necessary in the case of an addiction to tramadol'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males\n* ≥18 years\n* With no comorbid conditions (HTN, Diabetes \\& Epilepsy)\n* Tramadol addict (regular tramadol user)\n\nExclusion Criteria:\n\n* Females\n* ˂ 18 years\n* With comorbid conditions (HTN, Diabetes \\& Epilepsy)\n* ≥ 65 years males'}, 'identificationModule': {'nctId': 'NCT05418504', 'briefTitle': 'Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males', 'orgStudyIdInfo': {'id': 'REC-FOPFUE-16/119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non- Tramadol', 'description': 'the control group represented by dental patients who are not a tramadol addict', 'interventionNames': ['Drug: Dental anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol', 'description': 'The study group with patients seeking dental service but also are tramadol addict.', 'interventionNames': ['Drug: Dental anesthesia']}], 'interventions': [{'name': 'Dental anesthesia', 'type': 'DRUG', 'description': 'Dental anesthesia, used to do any dental procedure', 'armGroupLabels': ['Non- Tramadol', 'Tramadol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11817', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Doaa MS El-Bohy, PhD', 'role': 'CONTACT', 'email': 'delbohy@gmail.com', 'phone': '01224474013'}], 'facility': 'Doaa El-Bohy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Doaa El-Bohy, PhD', 'role': 'CONTACT'}], 'facility': 'Future University in egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Doaa MS El-Bohy, PhD', 'role': 'CONTACT', 'email': 'delbohy@gmail.com', 'phone': '01224474013'}, {'name': 'Heba A ElRamly, PhD', 'role': 'CONTACT', 'email': 'hramly146@gmail.com', 'phone': '01002134523'}], 'overallOfficials': [{'name': 'Doaa MS El-Bohy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FUE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant professor', 'investigatorFullName': 'Doaa Mohamed Salah ElDin Diab ELBohy', 'investigatorAffiliation': 'Future University in Egypt'}}}}