Tooth ExtractionLAINCT06766981
Infiltration Anesthesia vs. Block Anesthesia
A study testing Infiltration with Articain 4% and Inferior Alveolar Nerve Block in people with Tooth Extraction, run by Sinan A. Shwailiya at 2 sites in Iraq.
Trial summary
Checking the effectiveness of the infiltration technique of local anesthetic agent as an alternative to inferior dental nerve block during tooth extraction Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Infiltration with Articain 4% and Inferior Alveolar Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIraq
- Study dates
- 10 Jan 2025to 1 Mar 2025
- 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 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The systemic condition must be normal.
- Patient has no cardiovascular, metabolic, or transmitted disease.
- The patient has a Mandibular 1st. Molar tooth indicated for extraction.
- The tooth is non-restorable.
Who cannot join
- Chronic cardiovascular condition, metabolic, or infectious disease.
- Pregnant women.
- The tooth is restorable.
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites
College of Dentistry, University of Babylon
Hillah, Babylon, 00964
College of Dentistry/University of Babylon
Hillah, Babylon, 00964
About this study
Official title: Effectiveness of Local Anesthetic Infiltration With Articaine 4% in Comparison to Inferior Alveolar Nerve Block With Lidocaine 2% for Mandibular 1st Molar Extraction
Checking the effectiveness of the infiltration technique of local anesthetic agent as an alternative to inferior dental nerve block during tooth extraction
Read the detailed description
Patients who need their Mandibular first Molar to be removed under local anaesthesia. The first group will receive 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration. In comparison, the second group will receive a conventional inferior alveolar nerve block technique with 2% lidocaine with epinephrine (1:80,000). Pain will be measured para-operatively using a verbal rating scale.
- Conditions
- Tooth Extraction
- Being tested
- Infiltration with Articain 4%, Inferior Alveolar Nerve Block
- Keywords
- Local Anesthesia, Inferior Dental Nerve Block, Infiltration Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltration with Articain 4%Procedure or surgery
The experimental group of patients that are diagnosed for tooth extraction of mandibular 1st. molar will undergo extraction using an infiltration technique for local anaesthesia. In contrast to the conventional group that will receive Inferior alveolar nerve block
Inferior Alveolar Nerve BlockProcedure or surgery
Also called Regional Anaesthesia
This group will receive a conventional inferior alveolar nerve block (IANB) technique with 2% lidocaine with epinephrine (1:80,000) for tooth extraction.
| Study group | Role | What they receive |
|---|---|---|
| Block | Active comparator | This group will receive a conventional inferior alveolar nerve block (IANB) technique with 2% lidocaine with epinephrine (1:80,000) for tooth extraction. Receives: Procedure: Inferior Alveolar Nerve Block |
| Infiltration | Experimental | This group will receive 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration for tooth extraction Receives: Procedure: Infiltration with Articain 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Pain Rating Scale
Pain during tooth extraction will be measured immediately after the procedure is completed using a verbal rating scale. The zero rate will be given when the patient feels no pain; the rating degree will increase as the pain severity becomes more severe. According to the following scale:
0 No hurt
- Slight pain
- Moderate pain
- Intense pain
- Extremely painful
Measured: during the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start10 Jan 2025
- Primary completion10 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtractionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional group will undergo tooth extraction under the infiltration anaesthesia technique
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinan A. Shwailiya
- Sponsor type
- University, hospital or other
- Collaborators
- Babylon University
- Responsible party
- Sponsor-investigator, Sinan A. Shwailiya, Babylon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766981
- Sponsor's protocol ID
- 35/2024
- Acronym
- LAI
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study DATA will be provided on request
Publications
Bataineh AB, Nusair YM, Al-Rahahleh RQ. Comparative study of articaine and lidocaine without palatal injection for maxillary teeth extraction. Clin Oral Investig. 2019 Aug;23(8):3239-3248. doi: 10.1007/s00784-018-2738-x. Epub 2018 Nov 12.
PubMed 30417227Madden VJ, Kamerman P, Leake HB, Catley MJ, Heathcote LC, Moseley GL. The Sensation and Pain Rating Scale: easy to use, clear to interpret, and responsive to clinical change. medRxiv [Preprint]. 2024 Jan 9:2023.09.08.23295128. doi: 10.1101/2023.09.08.23295128.
PubMed 37732279
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Local Anesthetic Infiltration With Articaine 4% in Comparison to Inferior Alveolar Nerve Block With Lidocaine 2% for Mandibular 1st Molar Extraction
- ClinicalTrials.gov ID
- NCT06766981
- Acronym / sponsor ID
- LAI / 35/2024
- Conditions
- Tooth Extraction
- Keywords
- Local Anesthesia, Inferior Dental Nerve Block, Infiltration Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sinan A. ShwailiyaUniversity, hospital or other
- Collaborators
- Babylon University
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 9 Jan 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.
Checking the effectiveness of the infiltration technique of local anesthetic agent as an alternative to inferior dental nerve block during tooth extraction
Detailed description
Patients who need their Mandibular first Molar to be removed under local anaesthesia. The first group will receive 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration. In comparison, the second group will receive a conventional inferior alveolar nerve block technique with 2% lidocaine with epinephrine (1:80,000). Pain will be measured para-operatively using a verbal rating scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The interventional group will undergo tooth extraction under the infiltration anaesthesia technique
| Arm | Type | Receives |
|---|---|---|
| Block | Active comparator | Procedure: Inferior Alveolar Nerve BlockThis group will receive a conventional inferior alveolar nerve block (IANB) technique with 2% lidocaine with epinephrine (1:80,000) for tooth extraction. |
| Infiltration | Experimental | Procedure: Infiltration with Articain 4%This group will receive 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration for tooth extraction |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The systemic condition must be normal.
- Patient has no cardiovascular, metabolic, or transmitted disease.
- The patient has a Mandibular 1st. Molar tooth indicated for extraction.
- The tooth is non-restorable.
Key exclusion criteria (3 listed)
- Chronic cardiovascular condition, metabolic, or infectious disease.
- Pregnant women.
- The tooth is restorable.
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 |
|---|---|---|
| Infiltration with Articain 4%The experimental group of patients that are diagnosed for tooth extraction of mandibular 1st. molar will undergo extraction using an infiltration technique for local anaesthesia. In contrast to the conventional group that will receive Inferior alveolar nerve block | Procedure or surgery | Infiltration |
| Inferior Alveolar Nerve BlockAlso: Regional AnaesthesiaThis group will receive a conventional inferior alveolar nerve block (IANB) technique with 2% lidocaine with epinephrine (1:80,000) for tooth extraction. | Procedure or surgery | Block |
Primary outcome
Verbal Pain Rating Scale
Time frame: during the intervention/procedure/surgery
Pain during tooth extraction will be measured immediately after the procedure is completed using a verbal rating scale. The zero rate will be given when the patient feels no pain; the rating degree will increase as the pain severity becomes more severe. According to the following scale: 0 No hurt 1. Slight pain 2. Moderate pain 3. Intense pain 4. Extremely painful
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 Apr 2025.
- Background: PubMed 30417227Bataineh AB, Nusair YM, Al-Rahahleh RQ. Comparative study of articaine and lidocaine without palatal injection for maxillary teeth extraction. Clin Oral Investig. 2019 Aug;23(8):3239-3248. doi: 10.1007/s00784-018-2738-x. Epub 2018 Nov 12.
- Background: PubMed 37732279Madden VJ, Kamerman P, Leake HB, Catley MJ, Heathcote LC, Moseley GL. The Sensation and Pain Rating Scale: easy to use, clear to interpret, and responsive to clinical change. medRxiv [Preprint]. 2024 Jan 9:2023.09.08.23295128. doi: 10.1101/2023.09.08.23295128.
- Individual participant dataSharing planned: Yes. Study DATA will be provided on request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration with Articain 4% and Inferior Alveolar Nerve Block in people with Tooth Extraction, run by Sinan A. Shwailiya at 2 sites 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 4 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: finished, as of the sponsor's last update on 9 Apr 2025. 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 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?
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?
Verbal Pain Rating Scale (time frame: during the intervention/procedure/surgery). 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 NCT06766981, which also lists 2 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 9 Apr 2025.