Clinical trial

Study of Tramadol Addiction Impact on Dental Anesthesia Succes.

Name

Tramadol Addict Impact On Dent

Description

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.

Trial arms

Trial start

2023-06-10

Estimated PCD

2023-09-29

Trial end

2023-10-15

Status

Not yet recruiting

Phase

Early phase I

Treatment

articaine@ (4% 1:100000 epinephrine) dental anesthesia

Administration, calculation and adjustment of dental local anesthesia doses.

Arms:

Non addicted patients, Tramadol Addicted Patients

Other names:

mepivacaine@ (2%@ 1:100000 epinephrine) dental anesthesia

Size

300

Primary endpoint

Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect

3 months

To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures

3 months

Eligibility criteria

Inclusion Criteria: * Males * ≥18 years old \<65 * Without comorbid conditions (Hypertension, diabetes, Asthma etc..) * Tramadol addicted (regular tramadol user) * Only tramadol addicted, if any other drugs are regularly consumed, the patient is excluded. Exclusion Criteria: * Females * ˂ 18 years old * With comorbid conditions (HTN, diabetes, epilepsy etc..) * ≥ 65 years old men. * Not addicted to tramadol or addicted to other drugs with it.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Assessing local dental anesthesia success while performing different dental care among Algerian males addicted or not addicted to tramadol.', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Dentists providing dental care participating in the study are masked.', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

Updated at

2023-06-18

1 organization

1 product

5 indications

Organization

University of Algiers

Product

Indication

Indication

Indication

Indication

Substance Use Disorder

Indication

Opioid