Anesthesia, LocalNCT07731503
Conventional Versus Computer-Assisted Dental Anesthesia
A study testing Conventional Aspirating Dental Syringe in people with Anesthesia, Local, run by University of Montemorelos at 1 site in Mexico.
Trial summary
The purpose of this clinical trial was to compare two methods of delivering local dental anesthesia in undergraduate dental students: a computer-controlled local anesthetic delivery (CCLAD) system and a conventional dental syringe. 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?
- Conventional Aspirating Dental Syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteMexico
- Study dates
- 2 Sep 2025to 2 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergraduate dental student enrolled in the Local Anesthesia course at the Montemorelos University School of Dentistry.
- Aged 18 years or older.
- Able and willing to provide written informed consent.
- Willing to attend both study periods.
Who cannot join
- Pregnancy or lactation.
- Known allergy or contraindication to lidocaine or epinephrine.
- Systemic conditions contraindicating elective dental treatment.
- Use of medications that could alter cardiovascular responses.
- Medical condition that could interfere with pain perception or study participation.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
University Dental Clinic, Montemorelos University School of Dentistry
Montemorelos, Nuevo León, 67530
About this study
Official title: Conventional Versus Computer-Assisted Dental Anesthesia: A Pilot Study of a Randomized Clinical Trial
The purpose of this clinical trial was to compare two methods of delivering local dental anesthesia in undergraduate dental students: a computer-controlled local anesthetic delivery (CCLAD) system and a conventional dental syringe. The study evaluated whether the computer-controlled system reduced pain during the administration of local anesthesia compared with the conventional technique.
The main questions this study aimed to answer were:
Does a computer-controlled local anesthetic delivery system reduce pain during maxillary buccal infiltration compared with a conventional dental syringe? Are there differences in physiological responses (blood pressure, heart rate, and oxygen saturation) between the two anesthetic delivery methods? Which anesthetic delivery method do participants prefer after experiencing both techniques? Would participants recommend their preferred anesthetic delivery method to others? Participants attended two study visits approximately one week apart. Each participant received local anesthesia using both delivery methods in a randomized order, serving as his or her own control. Pain, dental anxiety, physiological parameters, anesthetic delivery preferences, and willingness to recommend the preferred method were assessed during the study.
- Conditions
- Anesthesia, Local
- Being tested
- Computer-Controlled Local Anesthetic Delivery System, Conventional Aspirating Dental Syringe
- Keywords
- Anesthesia, Local, Pain Measurement, Dental Anxiety, Students, Dental, Injections, Intraoral, Computer-controlled local anesthetic delivery, Split-mouth trial, Maxillary buccal infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Controlled Local Anesthetic Delivery SystemDevice
Also called SOGA-MINI
Local anesthetic was administered using a computer-controlled local anesthetic delivery (CCLAD) system with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia. The device controlled the flow rate throughout anesthetic administration according to the manufacturer's operating protocol.
Conventional Aspirating Dental SyringeDevice
Local anesthetic was administered using a conventional aspirating dental syringe with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia. Anesthetic administration followed the conventional manual injection technique.
| Study group | Role | What they receive |
|---|---|---|
| Computer-Controlled Local Anesthetic Delivery | Experimental | Participants received maxillary buccal infiltration anesthesia using a computer-controlled local anesthetic delivery (CCLAD) system during one of two study periods according to the randomized treatment sequence. Each participant received both study interventions and served as his or her own control. Receives: Device: Computer-Controlled Local Anesthetic Delivery System |
| Conventional Dental Syringe | Active comparator | Participants received maxillary buccal infiltration anesthesia using a conventional aspirating dental syringe during one of two study periods according to the randomized treatment sequence. Each participant received both study interventions and served as his or her own control. Receives: Device: Conventional Aspirating Dental Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception during local anesthetic administration
Pain perceived during maxillary buccal infiltration anesthesia administered with a computer-controlled local anesthetic delivery system or a conventional aspirating dental syringe. Pain was assessed immediately after each intervention using a 10-cm Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 indicated "worst imaginable pain".
Measured: Immediately after each anesthetic administration
Secondary outcomes (6)
Dental anxiety
Dental anxiety was assessed using the Modified Dental Anxiety Scale (MDAS; score range: 5-25). Higher scores indicate greater dental anxiety. Assessment was performed before the first study intervention.
Measured: Baseline (before the first study intervention)
Systolic and diastolic blood pressure
Blood pressure was measured using an automated monitor before, during, and immediately after anesthetic administration.
Measured: Before, during, and immediately after each anesthetic administration
Heart rate
Heart rate was measured using a pulse oximeter before, during, and immediately after anesthetic administration.
Measured: Before, during, and immediately after anesthetic administration
Peripheral oxygen saturation (SpO₂)
Peripheral oxygen saturation was measured using a pulse oximeter before, during, and immediately after anesthetic administration.
Measured: Before, during, and immediately after anesthetic administration
Participant-reported preferred anesthetic delivery method
Participants selected their preferred anesthetic delivery method (computer-controlled local anesthetic delivery system or conventional aspirating dental syringe) after experiencing both interventions.
Measured: Immediately after completion of the second study intervention
Willingness to recommend the preferred anesthetic delivery method
Willingness to recommend the preferred anesthetic delivery method was assessed using an 11-point Numeric Rating Scale (NRS; 0-10), where 0 indicated "not at all willing to recommend" and 10 indicated "extremely willing to recommend." Higher scores indicate greater willingness to recommend. Assessment was performed after completion of the second study intervention.
Measured: Immediately after completion of the second study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start2 Sep 2025
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This was a randomized, two-period, split-mouth crossover clinical trial in which each participant received both interventions (computer-controlled local anesthetic delivery and conventional dental syringe) in a randomized sequence during two study visits separated by a 1-week interval. Each participant served as his or her own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montemorelos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Leonardo Jimenez-Ortiz, University of Montemorelos
- Investigators
- Jose L Jimenez-Ortiz, DDS, Principal investigator, Montemorelos University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731503
- Sponsor's protocol ID
- UM-ESEST-2025-015
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A final decision regarding the sharing of de-identified individual participant data has not yet been made. Data sharing will be considered in accordance with institutional policies, participant confidentiality requirements, and applicable ethical and regulatory standards.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus Computer-Assisted Dental Anesthesia: A Pilot Study of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07731503
- Acronym / sponsor ID
- UM-ESEST-2025-015
- Conditions
- Anesthesia, Local
- Keywords
- Anesthesia, Local, Pain Measurement, Dental Anxiety, Students, Dental, Injections, Intraoral, Computer-controlled local anesthetic delivery, Split-mouth trial, Maxillary buccal infiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of MontemorelosUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 28 Jul 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 clinical trial was to compare two methods of delivering local dental anesthesia in undergraduate dental students: a computer-controlled local anesthetic delivery (CCLAD) system and a conventional dental syringe. The study evaluated whether the computer-controlled system reduced pain during the administration of local anesthesia compared with the conventional technique.
The main questions this study aimed to answer were:
Does a computer-controlled local anesthetic delivery system reduce pain during maxillary buccal infiltration compared with a conventional dental syringe? Are there differences in physiological responses (blood pressure, heart rate, and oxygen saturation) between the two anesthetic delivery methods? Which anesthetic delivery method do participants prefer after experiencing both techniques? Would participants recommend their preferred anesthetic delivery method to others? Participants attended two study visits approximately one week apart. Each participant received local anesthesia using both delivery methods in a randomized order, serving as his or her own control. Pain, dental anxiety, physiological parameters, anesthetic delivery preferences, and willingness to recommend the preferred method were assessed during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This was a randomized, two-period, split-mouth crossover clinical trial in which each participant received both interventions (computer-controlled local anesthetic delivery and conventional dental syringe) in a randomized sequence during two study visits separated by a 1-week interval. Each participant served as his or her own control.
| Arm | Type | Receives |
|---|---|---|
| Computer-Controlled Local Anesthetic Delivery | Experimental | Device: Computer-Controlled Local Anesthetic Delivery SystemParticipants received maxillary buccal infiltration anesthesia using a computer-controlled local anesthetic delivery (CCLAD) system during one of two study periods according to the randomized treatment sequence. Each participant received both study interventions and served as his or her own control. |
| Conventional Dental Syringe | Active comparator | Device: Conventional Aspirating Dental SyringeParticipants received maxillary buccal infiltration anesthesia using a conventional aspirating dental syringe during one of two study periods according to the randomized treatment sequence. Each participant received both study interventions and served as his or her own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergraduate dental student enrolled in the Local Anesthesia course at the Montemorelos University School of Dentistry.
- Aged 18 years or older.
- Able and willing to provide written informed consent.
- Willing to attend both study periods.
Key exclusion criteria (5 listed)
- Pregnancy or lactation.
- Known allergy or contraindication to lidocaine or epinephrine.
- Systemic conditions contraindicating elective dental treatment.
- Use of medications that could alter cardiovascular responses.
- Medical condition that could interfere with pain perception or study participation.
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 |
|---|---|---|
| Computer-Controlled Local Anesthetic Delivery SystemAlso: SOGA-MINILocal anesthetic was administered using a computer-controlled local anesthetic delivery (CCLAD) system with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia. The device controlled the flow rate throughout anesthetic administration according to the manufacturer's operating protocol. | Device | Computer-Controlled Local Anesthetic Delivery |
| Conventional Aspirating Dental SyringeLocal anesthetic was administered using a conventional aspirating dental syringe with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia. Anesthetic administration followed the conventional manual injection technique. | Device | Conventional Dental Syringe |
Primary outcome
Pain perception during local anesthetic administration
Time frame: Immediately after each anesthetic administration
Pain perceived during maxillary buccal infiltration anesthesia administered with a computer-controlled local anesthetic delivery system or a conventional aspirating dental syringe. Pain was assessed immediately after each intervention using a 10-cm Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 indicated "worst imaginable pain".
6 secondary outcomes
Dental anxiety
Time frame: Baseline (before the first study intervention)
Systolic and diastolic blood pressure
Time frame: Before, during, and immediately after each anesthetic administration
Heart rate
Time frame: Before, during, and immediately after anesthetic administration
Peripheral oxygen saturation (SpO₂)
Time frame: Before, during, and immediately after anesthetic administration
Participant-reported preferred anesthetic delivery method
Time frame: Immediately after completion of the second study intervention
Willingness to recommend the preferred anesthetic delivery method
Time frame: Immediately after completion of the second study intervention
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 28 Jul 2026.
- Individual participant dataSharing planned: Undecided. A final decision regarding the sharing of de-identified individual participant data has not yet been made. Data sharing will be considered in accordance with institutional policies, participant confidentiality requirements, and applicable ethical and regulatory standards.
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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.
Jose L Jimenez-Ortiz, DDS principal investigator
Montemorelos University School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Aspirating Dental Syringe in people with Anesthesia, Local, run by University of Montemorelos at 1 site in Mexico.
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 5 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 28 Jul 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 Mexico. 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?
Pain perception during local anesthetic administration (time frame: Immediately after each anesthetic administration). 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 28 Jul 2026.