PainPhase 2NCT05223075
Articaine Versus Lidocaine Buccal Infiltration
A Phase 2 study testing articaine local anethesia with vasoconstrictor and lidocaine local anethesia with vasoconstrictor in people with Pain, run by Fayoum University at 1 site in Egypt.
Trial summary
assess the effect of articaine versus lidocaine in only buccal infiltration of local anethesia in lower anterior teeth Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- articaine local anethesia with vasoconstrictor and lidocaine local anethesia with vasoconstrictor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2022to 2 Mar 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medically stable
- 18years or older
- patient with bilateral lower anterior teeth requiring non surgical removal
Who cannot join
- grade 3 mobility
- neurological disease
- allergy to anethesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Articaine Versus Lidocaine in Only Buccal Infiltration Anesthesia for the Extraction of Mandibular Anterior Teeth.Asplit Mouth Clinical Trail
assess the effect of articaine versus lidocaine in only buccal infiltration of local anethesia in lower anterior teeth
- Conditions
- Pain
- Being tested
- articaine local anethesia with vasoconstrictor, lidocaine local anethesia with vasoconstrictor
- Keywords
- buccal infiltration, lidocaine, articaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
articaine local anethesia with vasoconstrictorDrug
buccal infiltration only of articaine local anethesia during extraction of lower anterior teeth
lidocaine local anethesia with vasoconstrictorDrug
buccal infiltration only of lidocaine local anethesia during extraction of lower anterior teeth
| Study group | Role | What they receive |
|---|---|---|
| articaine group | Experimental | Not described Receives: Drug: articaine local anethesia with vasoconstrictor |
| lidocaine group | Experimental | Not described Receives: Drug: lidocaine local anethesia with vasoconstrictor |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during extraction
by (VAS) visual analouge scale
Measured: during extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start11 Nov 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223075
- Sponsor's protocol ID
- 256-06/2018
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Mahalawy H, El-Mahallawy Y, Abdelrahman HH, Refahee SM. Articaine versus Lidocaine in only buccal infiltration anesthesia for the extraction of mandibular anterior teeth. A prospective split-mouth randomized-controlled clinical study. BMC Oral Health. 2023 Aug 28;23(1):604. doi: 10.1186/s12903-023-03292-5.
PubMed 37641122
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Articaine Versus Lidocaine in Only Buccal Infiltration Anesthesia for the Extraction of Mandibular Anterior Teeth.Asplit Mouth Clinical Trail
- ClinicalTrials.gov ID
- NCT05223075
- Acronym / sponsor ID
- 256-06/2018
- Conditions
- Pain
- Keywords
- buccal infiltration, lidocaine, articaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 3 Feb 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.
assess the effect of articaine versus lidocaine in only buccal infiltration of local anethesia in lower anterior teeth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| articaine group | Experimental | Drug: articaine local anethesia with vasoconstrictor |
| lidocaine group | Experimental | Drug: lidocaine local anethesia with vasoconstrictor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medically stable
- 18years or older
- patient with bilateral lower anterior teeth requiring non surgical removal
Key exclusion criteria (3 listed)
- grade 3 mobility
- neurological disease
- allergy to anethesia
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 local anethesia with vasoconstrictorbuccal infiltration only of articaine local anethesia during extraction of lower anterior teeth | Drug | articaine group |
| lidocaine local anethesia with vasoconstrictorbuccal infiltration only of lidocaine local anethesia during extraction of lower anterior teeth | Drug | lidocaine group |
Primary outcome
pain during extraction
Time frame: during extraction
by (VAS) visual analouge scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 37641122Al-Mahalawy H, El-Mahallawy Y, Abdelrahman HH, Refahee SM. Articaine versus Lidocaine in only buccal infiltration anesthesia for the extraction of mandibular anterior teeth. A prospective split-mouth randomized-controlled clinical study. BMC Oral Health. 2023 Aug 28;23(1):604. doi: 10.1186/s12903-023-03292-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing articaine local anethesia with vasoconstrictor and lidocaine local anethesia with vasoconstrictor in people with Pain, run by Fayoum University at 1 site 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 3 inclusion and 3 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during extraction (time frame: during extraction). 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 NCT05223075, which also lists 1 linked publication.
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 15 Feb 2023.