Dental ProcedurePhase 4NCT05418504
Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males
A Phase 4 study testing Dental anesthesia in people with Dental Procedure, run by Future University in Egypt at 2 sites in Egypt.
Trial summary
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 Tramadol is an FDA-approved medication… 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 Procedure
- What is being tested?
- Dental anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2022to 1 Aug 2022
- 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
- With no comorbid conditions (HTN, Diabetes \& Epilepsy)
- Tramadol addict (regular tramadol user)
Who cannot join
- Females
- ˂ 18 years
- With comorbid conditions (HTN, Diabetes \& Epilepsy)
- ≥ 65 years males
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Doaa El-Bohy
Cairo, 11817
Doaa MS El-Bohy, PhD, 01224474013, delbohy@gmail.com
- Recruiting
Future University in egypt
Cairo
Doaa El-Bohy, PhD
About this study
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
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
Read the detailed description
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
- Conditions
- Dental Procedure
- Being tested
- Dental anesthesia
- Keywords
- Dental anesthesia, tramadol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental anesthesiaDrug
Dental anesthesia, used to do any dental procedure
| Study group | Role | What they receive |
|---|---|---|
| Non- Tramadol | Active comparator | the control group represented by dental patients who are not a tramadol addict Receives: Drug: Dental anesthesia |
| Tramadol | Active comparator | The study group with patients seeking dental service but also are tramadol addict. Receives: Drug: Dental anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia dose
Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms
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 posted14 Jun 2022
- Study start1 May 2022
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ProcedureStudies 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
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mohamed Salah ElDin Diab ELBohy, Future University in Egypt
- Investigators
- Doaa MS El-Bohy, PhD, Principal investigator, FUE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418504
- Sponsor's protocol ID
- REC-FOPFUE-16/119
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tramadol Addiction Impact on Dental Anesthesia Success Among Algerian Males
- ClinicalTrials.gov ID
- NCT05418504
- Acronym / sponsor ID
- REC-FOPFUE-16/119
- Conditions
- Dental Procedure
- Keywords
- Dental anesthesia, tramadol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 14 Jun 2022 (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.
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
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
Detailed description
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
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non- Tramadol | Active comparator | Drug: Dental anesthesiathe control group represented by dental patients who are not a tramadol addict |
| Tramadol | Active comparator | Drug: Dental anesthesiaThe study group with patients seeking dental service but also are tramadol addict. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males
- ≥18 years
- With no comorbid conditions (HTN, Diabetes \& Epilepsy)
- Tramadol addict (regular tramadol user)
Key exclusion criteria (4 listed)
- Females
- ˂ 18 years
- With comorbid conditions (HTN, Diabetes \& Epilepsy)
- ≥ 65 years males
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 |
|---|---|---|
| Dental anesthesiaDental anesthesia, used to do any dental procedure | Drug | Non- Tramadol, Tramadol |
Primary outcome
Anesthesia dose
Time frame: 3 months
Anesthesia carbols number through which both conc and dose needed in dental intervention in both arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
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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.
Doaa MS El-Bohy, PhD principal investigator
FUE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dental anesthesia in people with Dental Procedure, run by Future University in Egypt at 2 sites in Egypt.
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 4 inclusion and 4 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 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Doaa MS El-Bohy, PhD (01224474013, delbohy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia dose (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2022.