AnesthesiaPhase 2NCT07048834
Comparison of the Effectiveness of Articaine Local Infusion and Lidocaine Nerve Block in Lower Posterior Tooth Extraction.
A Phase 2 study testing lidocaine local anesthetic drug and articaine local anesthetic drug in people with Anesthesia, run by Amjed Fouad Hussein at 1 site in Iraq.
Trial summary
In this study 60 adult patients will participate and divided into two groups (30 for each). The first group will be anesthetized using 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block technique, while the second group will be anesthetized using 4 % articaine with 1:100,000 adrenaline via buccal… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- lidocaine local anesthetic drug and articaine local anesthetic drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 15 Mar 2021to 17 May 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- clinically healthy patients
Who cannot join
- Breastfeeding or pregnant
- Allergic to local anaesthetics drugs
- Lack full mental ability
- Infection at the extraction site
- Patient who currently taking opioids or under the influence of medicines that alter their perception of pain are not candidates for tooth extraction
Trial locations and contacts
1 site in 1 country.
About this study
In this study 60 adult patients will participate and divided into two groups (30 for each). The first group will be anesthetized using 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block technique, while the second group will be anesthetized using 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration technique in posterior teeth area. Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin.
After that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction.
Female patients who are breastfeeding or pregnant, those allergic to local anesthetics, lacking full mental ability, currently taking opioids, having an infection at the extraction site, or those under the influence of medicines that alter their perception of pain will be excluded from the study.
- Conditions
- Anesthesia
- Being tested
- lidocaine local anesthetic drug, articaine local anesthetic drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine local anesthetic drugOther
Lidocaine Nerve Block technique
articaine local anesthetic drugOther
Articaine Local Infusion technique
| Study group | Role | What they receive |
|---|---|---|
| patients anesthetized by 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block. | Other | This group of (30 patients) will be anesthetized using 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block technique, Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin.
After that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction Receives: Other: lidocaine local anesthetic drug |
| anesthetized by 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration. | Other | This group (of 30 patients) will be anesthetized using 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration technique in posterior teeth area. Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin.
After that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction. Receives: Other: articaine local anesthetic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS)
It usually is a horizontal line, 100 mm in length, anchored by word descriptors at each end, for example, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks on the line the point that the patient believes represents his or her perception of his or her current state.
Measured: five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start15 Mar 2021
- Primary completion20 Feb 2022
- Study completion17 May 2022
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 AnesthesiaStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amjed Fouad Hussein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amjed Fouad Hussein, Ahl al-Bayt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048834
- Sponsor's protocol ID
- 1419
- Status last verified
- Jul 2025
- First submitted
- 21 May 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to lack of participant consent for data Sharing. so, Individual participant data will not be shared due to the absence of specific provisions for broad external data sharing within the original informed consent documents signed by participants. Retrospective consent for such sharing is not feasible for this study population.
Publications
Webster S Jr, Drum M, Reader A, Fowler S, Nusstein J, Beck M. How Effective Is Supplemental Intraseptal Anesthesia in Patients with Symptomatic Irreversible Pulpitis? J Endod. 2016 Oct;42(10):1453-7. doi: 10.1016/j.joen.2016.07.002.
PubMed 27663614
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Articaine Local Infusion and Lidocaine Nerve Block in Lower Posterior Tooth Extraction.
- ClinicalTrials.gov ID
- NCT07048834
- Acronym / sponsor ID
- 1419
- Conditions
- Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Amjed Fouad HusseinUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 3 Jul 2025 (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.
In this study 60 adult patients will participate and divided into two groups (30 for each). The first group will be anesthetized using 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block technique, while the second group will be anesthetized using 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration technique in posterior teeth area. Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin.
After that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction.
Female patients who are breastfeeding or pregnant, those allergic to local anesthetics, lacking full mental ability, currently taking opioids, having an infection at the extraction site, or those under the influence of medicines that alter their perception of pain will be excluded from the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients anesthetized by 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block. | Other | Other: lidocaine local anesthetic drugThis group of (30 patients) will be anesthetized using 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block technique, Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin. After that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction |
| anesthetized by 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration. | Other | Other: articaine local anesthetic drugThis group (of 30 patients) will be anesthetized using 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration technique in posterior teeth area. Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin. After that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- clinically healthy patients
Key exclusion criteria (5 listed)
- Breastfeeding or pregnant
- Allergic to local anaesthetics drugs
- Lack full mental ability
- Infection at the extraction site
- Patient who currently taking opioids or under the influence of medicines that alter their perception of pain are not candidates for tooth extraction
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 |
|---|---|---|
| lidocaine local anesthetic drugLidocaine Nerve Block technique | Other | patients anesthetized by 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block. |
| articaine local anesthetic drugArticaine Local Infusion technique | Other | anesthetized by 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration. |
Primary outcome
visual analog scale (VAS)
Time frame: five minutes
It usually is a horizontal line, 100 mm in length, anchored by word descriptors at each end, for example, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks on the line the point that the patient believes represents his or her perception of his or her current state.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 27663614Webster S Jr, Drum M, Reader A, Fowler S, Nusstein J, Beck M. How Effective Is Supplemental Intraseptal Anesthesia in Patients with Symptomatic Irreversible Pulpitis? J Endod. 2016 Oct;42(10):1453-7. doi: 10.1016/j.joen.2016.07.002.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to lack of participant consent for data Sharing. so, Individual participant data will not be shared due to the absence of specific provisions for broad external data sharing within the original informed consent documents signed by participants. Retrospective consent for such sharing is not feasible for this study population.
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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 lidocaine local anesthetic drug and articaine local anesthetic drug in people with Anesthesia, run by Amjed Fouad Hussein at 1 site in Iraq.
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 1 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: finished, as of the sponsor's last update on 9 Jul 2025. 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 Iraq. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
visual analog scale (VAS) (time frame: five minutes). 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 NCT07048834, 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 9 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.