Anesthesia, LocalNCT05951907
The Anesthetic Efficacy of Lidocaine and Articaine as Buccal Injection for Maxillary Premolar Teeth Extraction.
A study testing Maxillary extraction without palatal injection and Maxillary extraction with buccal and palatal injection in people with Anesthesia, Local, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study Is designed as a prospective randomized, single-blinded clinical trial. To evaluate The anesthetic efficacy of articaine as a buccal Injection for maxillary premolar teeth extraction, compared to lidocaine as a buccal and palatal injection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Maxillary extraction without palatal injection and Maxillary extraction with buccal and palatal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 5 Jan 2022to Sep 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 16 years old, including both genders.
- Patients indicated for extraction of one of the maxillary premolar's teeth.
Who cannot join
- Patients who were allergic to the local anesthetic agents used in this study.
- Patients who presented with acute periapical infections.
- Patients who required surgical extraction that entails flap reflection and bone removal.
- Pregnant patients.
- Patients with uncontrolled systemic diseases.
- Patients are taking medications affecting pain assessment, like opioids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Anesthetic Efficacy of Articaine as Buccal Injection Compared to Lidocaine Baccual and Palatal Injection for Maxillary Premolar Teeth Extraction A Randomized, Single-Blinded, Clinical Trial.
This study Is designed as a prospective randomized, single-blinded clinical trial. To evaluate The anesthetic efficacy of articaine as a buccal Injection for maxillary premolar teeth extraction, compared to lidocaine as a buccal and palatal injection.
Read the detailed description
In the current study, the sample size (200) patients were distributed into two groups, group (A), 100 patients extracted upper premolar teeth by using 1.8 mL cartridges of 4% articaine hydrochloride with 1:100,000 epinephrine (Artheek, Colombia) as a buccal injection without palatal injection, and Group (B), 100 patients were removed upper premolar teeth by using Injectable local anesthetic agents included; 1.8 mL cartridges of 2% lidocaine hydrochloride with 1:80,000 epinephrine (Huons, Korea) as a buccal and palatal injection, the pain assessment after extraction was assessed by using (vas) visual analog scale, comparison between the outcomes by the two groups were evaluated, according to many variables (age, gender, extracted tooth, type of anesthesia, extraction duration).
- Conditions
- Anesthesia, Local
- Being tested
- Maxillary extraction without palatal injection, Maxillary extraction with buccal and palatal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary extraction without palatal injectionProcedure or surgery
Extraction of maxillary premolars by only buccal injection without palatal by using articaine 4% HCL with epinephrine (1:100,000)
Maxillary extraction with buccal and palatal injectionProcedure or surgery
Extraction of maxillary premolars by only buccal and palatal injection by using lidocaine 2 % HCL with epinephrine (1:80,000)
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | A control group in which the extraction of the maxillary premolar's teeth was carried out under buccal and palatal infiltration anesthesia with 1.8 mL 2% lidocaine hydrochloride with 1:80,000 epinephrine. Receives: Procedure: Maxillary extraction with buccal and palatal injection |
| study group | Experimental | A study group in which the extraction of the maxillary premolar's teeth proceeded under buccal without palatal infiltration anesthesia with 1.8 mL, 4% articaine hydrochloride with 1:100,000 epinephrine. Receives: Procedure: Maxillary extraction without palatal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during Extraction
In the current study the pain during extraction was assessed by using the Visual Analogue Scale (VAS 0-10 cm ) one of the most commonly used self-reporting measures of pain, it measures a characteristic that is believed to range across a continuum of values range from (0 no pain) to the end (10 un bearable pain) which is not easy to measure directly .
Measured: Assessment of pain in the period during which the extraction has been made and up to 5 minutes after extraction of the tooth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start5 Jan 2022
- Primary completion10 Dec 2022
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case-Control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almustafa Qays Abdulkareem, University of Baghdad
- Investigators
- Hasanain A. Al-Jumaily, C.A.B.M.S, Study director, College of Dentistry - University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951907
- Sponsor's protocol ID
- Extraction By Articaine
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anesthetic Efficacy of Articaine as Buccal Injection Compared to Lidocaine Baccual and Palatal Injection for Maxillary Premolar Teeth Extraction A Randomized, Single-Blinded, Clinical Trial.
- ClinicalTrials.gov ID
- NCT05951907
- Acronym / sponsor ID
- Extraction By Articaine
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 19 Jul 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.
This study Is designed as a prospective randomized, single-blinded clinical trial. To evaluate The anesthetic efficacy of articaine as a buccal Injection for maxillary premolar teeth extraction, compared to lidocaine as a buccal and palatal injection.
Detailed description
In the current study, the sample size (200) patients were distributed into two groups, group (A), 100 patients extracted upper premolar teeth by using 1.8 mL cartridges of 4% articaine hydrochloride with 1:100,000 epinephrine (Artheek, Colombia) as a buccal injection without palatal injection, and Group (B), 100 patients were removed upper premolar teeth by using Injectable local anesthetic agents included; 1.8 mL cartridges of 2% lidocaine hydrochloride with 1:80,000 epinephrine (Huons, Korea) as a buccal and palatal injection, the pain assessment after extraction was assessed by using (vas) visual analog scale, comparison between the outcomes by the two groups were evaluated, according to many variables (age, gender, extracted tooth, type of anesthesia, extraction duration).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Case-Control
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: Maxillary extraction with buccal and palatal injectionA control group in which the extraction of the maxillary premolar's teeth was carried out under buccal and palatal infiltration anesthesia with 1.8 mL 2% lidocaine hydrochloride with 1:80,000 epinephrine. |
| study group | Experimental | Procedure: Maxillary extraction without palatal injectionA study group in which the extraction of the maxillary premolar's teeth proceeded under buccal without palatal infiltration anesthesia with 1.8 mL, 4% articaine hydrochloride with 1:100,000 epinephrine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 16 years old, including both genders.
- Patients indicated for extraction of one of the maxillary premolar's teeth.
Key exclusion criteria (6 listed)
- Patients who were allergic to the local anesthetic agents used in this study.
- Patients who presented with acute periapical infections.
- Patients who required surgical extraction that entails flap reflection and bone removal.
- Pregnant patients.
- Patients with uncontrolled systemic diseases.
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 |
|---|---|---|
| Maxillary extraction without palatal injectionExtraction of maxillary premolars by only buccal injection without palatal by using articaine 4% HCL with epinephrine (1:100,000) | Procedure or surgery | study group |
| Maxillary extraction with buccal and palatal injectionExtraction of maxillary premolars by only buccal and palatal injection by using lidocaine 2 % HCL with epinephrine (1:80,000) | Procedure or surgery | control group |
Primary outcome
Pain during Extraction
Time frame: Assessment of pain in the period during which the extraction has been made and up to 5 minutes after extraction of the tooth.
In the current study the pain during extraction was assessed by using the Visual Analogue Scale (VAS 0-10 cm ) one of the most commonly used self-reporting measures of pain, it measures a characteristic that is believed to range across a continuum of values range from (0 no pain) to the end (10 un bearable pain) which is not easy to measure directly .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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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.
Hasanain A. Al-Jumaily, C.A.B.M.S study director
College of Dentistry - University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary extraction without palatal injection and Maxillary extraction with buccal and palatal injection in people with Anesthesia, Local, run by University of Baghdad 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 2 inclusion and 6 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 19 Jul 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 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.
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: Assessment of pain in the period during which the extraction has been made and up to 5 minutes after extraction of the tooth.). 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 19 Jul 2023.