Dental Pain and Sensation DisorderPhase 4NCT05908305
Impact of Tramadol Addiction On Dental Anesthesia Success
A Phase 4 study testing articaine@ (4% 1:100000 epinephrine) dental anesthesia in people with Dental Pain and Sensation Disorder and Anesthesia, Local, run by University of Algiers.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Pain and Sensation Disorder, Anesthesia, Local, Addiction, Opioid
- What is being tested?
- articaine@ (4% 1:100000 epinephrine) dental anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2023to 15 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of Tramadol Addiction Impact on Dental Anesthesia Succes.
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.
Read the detailed description
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.
The 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.
Tramadol 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.
Tramadol 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.
- Being tested
- articaine@ (4% 1:100000 epinephrine) dental anesthesia
- Keywords
- Tramadol, Addiction, Local Anesthesia, Dentistry, Carpule
- Medical subject headings
- Toothache, Sensation Disorders, Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
articaine@ (4% 1:100000 epinephrine) dental anesthesiaDrug
Also called mepivacaine@ (2%@ 1:100000 epinephrine) dental anesthesia
Administration, calculation and adjustment of dental local anesthesia doses.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol Addicted Patients | Active comparator | It represents the group of tramadol addicted patients seeking dental care that require dental anesthesia. Receives: Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia |
| Non addicted patients | Active comparator | The group of patients requiring dental care with local anesthesia and who are not addicted to tramadol. Receives: Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect
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.
Measured: 3 months
To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures
Among addicted and non-addicted patients, the number of carpules of dental anesthesia necessary for total analgesic effect will be determined.
Measured: 3 months
Secondary outcomes (1)
To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start10 Jun 2023 (estimated)
- Primary completion29 Sep 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental Pain and Sensation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Assessing local dental anesthesia success while performing different dental care among Algerian males addicted or not addicted to tramadol.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Algiers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Amir Rais, University of Algiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908305
- Sponsor's protocol ID
- Tramadol Addict Impact On Dent
- Status last verified
- Jun 2023
- First submitted
- 4 Dec 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24346042Guven 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.
PubMed 15804720Premnath 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.
PubMed 32467795Fung EY, Giannini PJ. Implications of drug dependence on dental patient management. Gen Dent. 2010 May-Jun;58(3):236-41; quiz 242-3.
PubMed 20478804
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tramadol Addiction Impact on Dental Anesthesia Succes.
- ClinicalTrials.gov ID
- NCT05908305
- Acronym / sponsor ID
- Tramadol Addict Impact On Dent
- Keywords
- Tramadol, Addiction, Local Anesthesia, Dentistry, Carpule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AlgiersUniversity, hospital or other
- Study start
- 10 Jun 2023 (estimated)
- Primary completion
- 29 Sep 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The 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.
Tramadol 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.
Tramadol 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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Assessing local dental anesthesia success while performing different dental care among Algerian males addicted or not addicted to tramadol.
| Arm | Type | Receives |
|---|---|---|
| Tramadol Addicted Patients | Active comparator | Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesiaIt represents the group of tramadol addicted patients seeking dental care that require dental anesthesia. |
| Non addicted patients | Active comparator | Drug: articaine@ (4% 1:100000 epinephrine) dental anesthesiaThe group of patients requiring dental care with local anesthesia and who are not addicted to tramadol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| articaine@ (4% 1:100000 epinephrine) dental anesthesiaAlso: mepivacaine@ (2%@ 1:100000 epinephrine) dental anesthesiaAdministration, calculation and adjustment of dental local anesthesia doses. | Drug | Non addicted patients, Tramadol Addicted Patients |
Primary outcome
Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect
Time frame: 3 months
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.
To determine the number of dental anesthesia carpules used for each group participants during dental and oral procedures
Time frame: 3 months
Among addicted and non-addicted patients, the number of carpules of dental anesthesia necessary for total analgesic effect will be determined.
1 secondary outcome
To determine the quantity ( mg) of tramadol and the time of consumption ( in months) necessary to cause dental anesthesia failure among addicted patients.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 24346042Carnaval 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.
- Background: PubMed 15804720Guven 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.
- Background: PubMed 32467795Premnath 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.
- Background: PubMed 20478804Fung EY, Giannini PJ. Implications of drug dependence on dental patient management. Gen Dent. 2010 May-Jun;58(3):236-41; quiz 242-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing articaine@ (4% 1:100000 epinephrine) dental anesthesia in people with Dental Pain and Sensation Disorder and Anesthesia, Local, run by University of Algiers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Amir Rais, DMD (+213696988763, raismohammedamir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring in (ML) the quantity of dental anesthesia used in each participants group to achieve analgesic effect (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05908305, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.