Fist and Second Molars With ırreversible PulpitisNCT06342869
Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis
A study testing Anesthesia in people with Fist and Second Molars With ırreversible Pulpitis, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fist and Second Molars With ırreversible Pulpitis
- What is being tested?
- Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Dec 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient must be a healthy individual between the ages of 18 and 65 who is classified as ASA I and II.
- No allergy to local anesthetic substances to be used in the study
- Upper maxillary molars with irreversible pulpitis whose vitality has been proven by pulp tests, with no radiolucency at the root tip
- Not having used any painkillers, antibiotics, antidepressants and sedative drugs in the last 12 hours
- Being capable of understanding the Pain scale
Who cannot join
- Allergy to local anesthetics
- Failure to respond to the cold test and electric pulp test performed on the relevant tooth
- Radiolucent lesion in the apical part of the relevant tooth on periapical radiography
- No vital tissue is encountered when the pulp chamber is opened
Trial locations and contacts
1 site in 1 country.
About this study
Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis.
Method: Among the patients who applied to Akdeniz University Faculty of Dentistry Endodontic Clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. Eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. Pain during the endodontic procedure was determined and recorded according to the Heft Parker visual analog scale.
- Being tested
- Anesthesia
- Keywords
- articaine, lidocaine, irreversible pulpitis, infiltration anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnesthesiaProcedure or surgery
application of different anesthesia techniques
| Study group | Role | What they receive |
|---|---|---|
| buccal infiltration with 4% articaine containing 1:100,000 epinephrine | Experimental | Not described Receives: Procedure: Anesthesia |
| buccal infiltration with 2% lidocaine containing 80,000 epinephrine | Experimental | Not described Receives: Procedure: Anesthesia |
| buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine | Experimental | Not described Receives: Procedure: Anesthesia |
| buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine | Experimental | Not described Receives: Procedure: Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of complementary palatinal anesthesia with VAS
Measured: 10 minutes after anesthesia is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Apr 2022
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
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 Fist and Second Molars With ırreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Akdeniz 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Kırıcı, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342869
- Sponsor's protocol ID
- 690
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kanaa MD, Whitworth JM, Meechan JG. A comparison of the efficacy of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:80,000 epinephrine in achieving pulpal anesthesia in maxillary teeth with irreversible pulpitis. J Endod. 2012 Mar;38(3):279-82. doi: 10.1016/j.joen.2011.11.010. Epub 2011 Dec 22.
PubMed 22341059Kolay D, Kirici D. Comparison of the effects of lidocaine and articaine used for buccal infiltration and supplemental palatinal infiltration anesthesia in maxillary molars with irreversible pulpitis: a prospective randomized study. BMC Oral Health. 2025 Feb 8;25(1):207. doi: 10.1186/s12903-025-05552-y.
PubMed 39923048
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT06342869
- Acronym / sponsor ID
- 690
- Keywords
- articaine, lidocaine, irreversible pulpitis, infiltration anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 2 Apr 2024 (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.
Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis.
Method: Among the patients who applied to Akdeniz University Faculty of Dentistry Endodontic Clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. Eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. Pain during the endodontic procedure was determined and recorded according to the Heft Parker visual analog scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| buccal infiltration with 4% articaine containing 1:100,000 epinephrine | Experimental | Procedure: Anesthesia |
| buccal infiltration with 2% lidocaine containing 80,000 epinephrine | Experimental | Procedure: Anesthesia |
| buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine | Experimental | Procedure: Anesthesia |
| buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine | Experimental | Procedure: Anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must be a healthy individual between the ages of 18 and 65 who is classified as ASA I and II.
- No allergy to local anesthetic substances to be used in the study
- Upper maxillary molars with irreversible pulpitis whose vitality has been proven by pulp tests, with no radiolucency at the root tip
- Not having used any painkillers, antibiotics, antidepressants and sedative drugs in the last 12 hours
- Being capable of understanding the Pain scale
Key exclusion criteria (4 listed)
- Allergy to local anesthetics
- Failure to respond to the cold test and electric pulp test performed on the relevant tooth
- Radiolucent lesion in the apical part of the relevant tooth on periapical radiography
- No vital tissue is encountered when the pulp chamber is opened
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 |
|---|---|---|
| Anesthesiaapplication of different anesthesia techniques | Procedure or surgery | buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine, buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, buccal infiltration with 2% lidocaine containing 80,000 epinephrine, buccal infiltration with 4% articaine containing 1:100,000 epinephrine |
Primary outcome
Assessment of complementary palatinal anesthesia with VAS
Time frame: 10 minutes after anesthesia is performed
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 2 Apr 2024.
- Background: PubMed 22341059Kanaa MD, Whitworth JM, Meechan JG. A comparison of the efficacy of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:80,000 epinephrine in achieving pulpal anesthesia in maxillary teeth with irreversible pulpitis. J Endod. 2012 Mar;38(3):279-82. doi: 10.1016/j.joen.2011.11.010. Epub 2011 Dec 22.
- Derived from this study: PubMed 39923048Kolay D, Kirici D. Comparison of the effects of lidocaine and articaine used for buccal infiltration and supplemental palatinal infiltration anesthesia in maxillary molars with irreversible pulpitis: a prospective randomized study. BMC Oral Health. 2025 Feb 8;25(1):207. doi: 10.1186/s12903-025-05552-y.
- Individual participant dataSharing planned: Undecided
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 study testing Anesthesia in people with Fist and Second Molars With ırreversible Pulpitis, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 2 Apr 2024. 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 Turkey (Türkiye). 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?
Assessment of complementary palatinal anesthesia with VAS (time frame: 10 minutes after anesthesia is performed). 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 NCT06342869, 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 2 Apr 2024.