Comparative Evaluation of the Effect of pH Adjustment of the Solution of Articaine With Epinephrine on the Efficacy of Jet AnesthesiaNCT07318311
Comparative Evaluation of the Effect of pH Adjustment of the Solution of Articaine With Epinephrine on the Efficacy of Jet Anesthesia
A study testing Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device and Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in device in people with Comparative Evaluation of the Effect of pH Adjustment of the Solution of Articaine With Epinephrine on the Efficacy of Jet Anesthesia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate the effect of pH adjustment of the solution of articaine 4% with epinephrine 1:100.00, on the efficacy of anesthesia with the usage of a local anesthesia device that is needle-free (Comfort-In), and uses pressure implementation. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparative Evaluation of the Effect of pH Adjustment of the Solution of Articaine With Epinephrine on the Efficacy of Jet Anesthesia
- What is being tested?
- Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device and Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 1 Aug 2022to 7 Nov 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Healthy adults (ASA I) whose medical history allows the administration of local anesthesia with vasoconstrictor, 2) Volunteers without dental fear or any other phobia, 3) Volunteers males/females aged 18-35, 4) Volunteers with intact upper central incisor (#11) with viable, non-inflamed pulp tissue, without trauma history, periodontal disease, or decay, without rehabilitation.
Who cannot join
- 1) Allergy history in local anesthetic solutions, 2) Pregnancy or breastfeeding, 3) Pathological lesions or active inflammation spots in the area of infusion, 4) Volunteers that receive chronic medication that presents interactions with local anesthesia solutions and mainly with vasoconstrictors (e.g. TCA or b-blockers), and volunteers that have received suppressants of CNS up to 48 hours before the administration (e.g. alcohol or NSAIDs) as they cause disorder of sensibility.
- -
Trial locations and contacts
1 site in 1 country.
Greece1 site
Dental School Aristotle University of Thessaloniki
Thessaloniki, 54124
About this study
The purpose of this study is to evaluate the effect of pH adjustment of the solution of articaine 4% with epinephrine 1:100.00, on the efficacy of anesthesia with the usage of a local anesthesia device that is needle-free (Comfort-In), and uses pressure implementation. An additional purpose of the study is to evaluate the efficacy of the device and its acceptance by the patients.
Read the detailed description
In the present clinical research of the Dental School of the Aristotle University of Thessaloniki, there were forty-five healthy adult participants (ASA I) with no dental or other phobia, not being pregnant or going through breastfeeding process, with a record free of any allergies caused by local anaesthetics or the intake of suppressant substances of the central nervous system (CNS), and with an intact upper central incisor jaw #11 (viable, non-inflamed pulp tissue without rehabilitation). The participants took part in the study voluntarily, after being informed about the process through a special information sheet, and then signing a printed consent form. Medical and dental record was taken afterwards, which included questions about the volunteer's general experience concerning local anaesthesia, and also clinical examination was carried out to find out whether the volunteers qualify for research inclusion. The next step was the implementation of local anaesthesia with the usage of the jet device Comfort-In in the area of the upper central incisor of the right quadrant (#11), held in two separate sessions, the second one occurring at least one week after the first one. Specifically, the double blind method was used and the anaesthetic solutions infused randomly were 0.3ml of articaine 4% with adrenaline 1/100000 and 0.3ml of articaine 4% with adrenaline 1/100000 with the addition of the regulatory solution of sodium bicarbonate 8,4%. Right after the infusion of each anaesthetic solution and every 2 minutes, vitality tests of the pulp via an electric pulp-tester as well as tests of the sensitivity of the gums via the implication of cotton forceps were held and recorded, until anaesthesia had gone away completely. During the session, while infusing the anaesthetic, an evaluation of the pain was held (visual, numerical and operational proportional scale of pain - VAS), and also, the participant replied to 6 questions by completing a corresponding questionnaire relevant to the acceptance of the technique. After 48 hours, the main researcher contacted every volunteer to record any post-operative complications.
- Being tested
- Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device, Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in device
- Keywords
- articaine, buffer, alkalization, needle-free local anesthesia, jet system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in deviceOther
Implementation of local anesthesia with the usage of the jet device Comfort-In in the area of the upper central incisor of the right quadrant (#11). Specifically, the anesthetic solution infused was 0.3ml of articaine 4% with adrenaline 1/100000.
Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in deviceOther
Implementation of local anesthesia with the usage of the jet device Comfort-In in the area of the upper central incisor of the right quadrant (#11). Specifically, the anesthetic solution infused was 0.3ml of articaine 4% with adrenaline 1/100000 with the addition of the regulatory solution of sodium bicarbonate 8,4%.
| Study group | Role | What they receive |
|---|---|---|
| Control-Non buffered | Other | Local anesthesia administration articaine 4% with adrenaline 1/100000 via Comfort-in device Receives: Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device; Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in device |
| Experimental-buffered | Experimental | Local anesthesia administration articaine 4% with adrenaline 1/100000 with the addition of sodium bicarbonate 8,4% via Comfort-in device Receives: Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device; Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of pulpal anesthesia
Calculation of the percentage of participants with successful anesthesia via pulp-tester
Measured: 2 minutes after the infusion of the anesthetic via Comfort-in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Aug 2022
- Primary completion30 Oct 2022
- Study completion7 Nov 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 Comparative Evaluation of the Effect of pH Adjustment of the Solution of Articaine With Epinephrine on the Efficacy of Jet AnesthesiaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaos Dabarakis, Associate Professor, Study chair, Aristotle University Of ThessalonikiTheodoros Lilis, Assistant Professor, Study director, Aristotle University Of ThessalonikiVasileios Kyros, Postgraduate Student, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318311
- Sponsor's protocol ID
- 0620152
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manta K, Dabarakis N, Lillis T, Fotopoulos I. Anesthetic efficacy of buffered 4% articaine for mandibular first molar infiltration: a crossover clinical trial. J Dent Anesth Pain Med. 2023 Jun;23(3):135-141. doi: 10.17245/jdapm.2023.23.3.135. Epub 2023 May 26.
PubMed 37313270
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effect of pH Adjustment of the Solution of Articaine With Epinephrine on the Efficacy of Jet Anesthesia
- ClinicalTrials.gov ID
- NCT07318311
- Acronym / sponsor ID
- 0620152
- Keywords
- articaine, buffer, alkalization, needle-free local anesthesia, jet system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 5 Jan 2026 (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.
The purpose of this study is to evaluate the effect of pH adjustment of the solution of articaine 4% with epinephrine 1:100.00, on the efficacy of anesthesia with the usage of a local anesthesia device that is needle-free (Comfort-In), and uses pressure implementation. An additional purpose of the study is to evaluate the efficacy of the device and its acceptance by the patients.
Detailed description
In the present clinical research of the Dental School of the Aristotle University of Thessaloniki, there were forty-five healthy adult participants (ASA I) with no dental or other phobia, not being pregnant or going through breastfeeding process, with a record free of any allergies caused by local anaesthetics or the intake of suppressant substances of the central nervous system (CNS), and with an intact upper central incisor jaw #11 (viable, non-inflamed pulp tissue without rehabilitation). The participants took part in the study voluntarily, after being informed about the process through a special information sheet, and then signing a printed consent form. Medical and dental record was taken afterwards, which included questions about the volunteer's general experience concerning local anaesthesia, and also clinical examination was carried out to find out whether the volunteers qualify for research inclusion. The next step was the implementation of local anaesthesia with the usage of the jet device Comfort-In in the area of the upper central incisor of the right quadrant (#11), held in two separate sessions, the second one occurring at least one week after the first one. Specifically, the double blind method was used and the anaesthetic solutions infused randomly were 0.3ml of articaine 4% with adrenaline 1/100000 and 0.3ml of articaine 4% with adrenaline 1/100000 with the addition of the regulatory solution of sodium bicarbonate 8,4%. Right after the infusion of each anaesthetic solution and every 2 minutes, vitality tests of the pulp via an electric pulp-tester as well as tests of the sensitivity of the gums via the implication of cotton forceps were held and recorded, until anaesthesia had gone away completely. During the session, while infusing the anaesthetic, an evaluation of the pain was held (visual, numerical and operational proportional scale of pain - VAS), and also, the participant replied to 6 questions by completing a corresponding questionnaire relevant to the acceptance of the technique. After 48 hours, the main researcher contacted every volunteer to record any post-operative complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Non buffered | Other | Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device, Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in deviceLocal anesthesia administration articaine 4% with adrenaline 1/100000 via Comfort-in device |
| Experimental-buffered | Experimental | Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device, Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in deviceLocal anesthesia administration articaine 4% with adrenaline 1/100000 with the addition of sodium bicarbonate 8,4% via Comfort-in device |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) Healthy adults (ASA I) whose medical history allows the administration of local anesthesia with vasoconstrictor, 2) Volunteers without dental fear or any other phobia, 3) Volunteers males/females aged 18-35, 4) Volunteers with intact upper central incisor (#11) with viable, non-inflamed pulp tissue, without trauma history, periodontal disease, or decay, without rehabilitation.
Key exclusion criteria (2 listed)
- 1) Allergy history in local anesthetic solutions, 2) Pregnancy or breastfeeding, 3) Pathological lesions or active inflammation spots in the area of infusion, 4) Volunteers that receive chronic medication that presents interactions with local anesthesia solutions and mainly with vasoconstrictors (e.g. TCA or b-blockers), and volunteers that have received suppressants of CNS up to 48 hours before the administration (e.g. alcohol or NSAIDs) as they cause disorder of sensibility.
- -
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 |
|---|---|---|
| Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in deviceImplementation of local anesthesia with the usage of the jet device Comfort-In in the area of the upper central incisor of the right quadrant (#11). Specifically, the anesthetic solution infused was 0.3ml of articaine 4% with adrenaline 1/100000. | Other | Control-Non buffered, Experimental-buffered |
| Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in deviceImplementation of local anesthesia with the usage of the jet device Comfort-In in the area of the upper central incisor of the right quadrant (#11). Specifically, the anesthetic solution infused was 0.3ml of articaine 4% with adrenaline 1/100000 with the addition of the regulatory solution of sodium bicarbonate 8,4%. | Other | Control-Non buffered, Experimental-buffered |
Primary outcome
Success rate of pulpal anesthesia
Time frame: 2 minutes after the infusion of the anesthetic via Comfort-in
Calculation of the percentage of participants with successful anesthesia via pulp-tester
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 5 Jan 2026.
- Results publication: PubMed 37313270Manta K, Dabarakis N, Lillis T, Fotopoulos I. Anesthetic efficacy of buffered 4% articaine for mandibular first molar infiltration: a crossover clinical trial. J Dent Anesth Pain Med. 2023 Jun;23(3):135-141. doi: 10.17245/jdapm.2023.23.3.135. Epub 2023 May 26.
- Individual participant dataSharing planned: No
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.
Nikolaos Dabarakis, Associate Professor study chair
Aristotle University Of Thessaloniki
Theodoros Lilis, Assistant Professor study director
Aristotle University Of Thessaloniki
Vasileios Kyros, Postgraduate Student principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device and Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in device in people with Comparative Evaluation of the Effect of pH Adjustment of the Solution of Articaine With Epinephrine on the Efficacy of Jet Anesthesia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 2 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 5 Jan 2026. 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 Greece. 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?
Success rate of pulpal anesthesia (time frame: 2 minutes after the infusion of the anesthetic via Comfort-in). 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 NCT07318311, 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 5 Jan 2026.