Comparative Evaluation of the Effect of pH Adjustment of the Solution of Articaine With Epinephrine on the Efficacy of Jet Anesthesia

December 23, 2025 updated by: Aristotle University Of Thessaloniki
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54124
        • Dental School Aristotle University of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control-Non buffered
Local anesthesia administration articaine 4% with adrenaline 1/100000 via Comfort-in device
Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device
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.
Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in device
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%.
Experimental: Experimental-buffered
Local anesthesia administration articaine 4% with adrenaline 1/100000 with the addition of sodium bicarbonate 8,4% via Comfort-in device
Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine by using Comfort-in device
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.
Other: Local anesthesia with articaine 4% with 1:100.000 epinephrine with the addition of sodium bicarbonate 8,4% by using Comfort-in device
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%.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 minutes after the infusion of the anesthetic via Comfort-in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristotle University Of Thessaloniki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nikolaos Dabarakis, Associate Professor, Aristotle University Of Thessaloniki
  • Study Director: Theodoros Lilis, Assistant Professor, Aristotle University Of Thessaloniki
  • Principal Investigator: Vasileios Kyros, Postgraduate Student, Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0620152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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