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Completed

NCT Number: NCT07731503

Conventional Versus Computer-Assisted Dental Anesthesia

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.

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Key information

Conditions

Anesthesia, Local

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Dental Clinic, Montemorelos University School of Dentistry

Montemorelos, Nuevo León, 67530, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Computer-controlled Local Anesthetic delivery system

Device

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.

Other names: SOGA-MINI

Conventional Aspirating Dental Syringe

Device

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.

Primary outcomes

  1. 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".

Secondary outcomes

  1. Dental anxiety

    Time frame: Baseline (before the first study intervention)

    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.

  2. Systolic and diastolic blood pressure

    Time frame: Before, during, and immediately after each anesthetic administration

    Blood pressure was measured using an automated monitor before, during, and immediately after anesthetic administration.

  3. Heart rate

    Time frame: Before, during, and immediately after anesthetic administration

    Heart rate was measured using a pulse oximeter before, during, and immediately after anesthetic administration.

  4. Peripheral oxygen saturation (SpO₂)

    Time frame: Before, during, and immediately after anesthetic administration

    Peripheral oxygen saturation was measured using a pulse oximeter before, during, and immediately after anesthetic administration.

  5. Participant-reported preferred anesthetic delivery method

    Time frame: Immediately after completion of the second study intervention

    Participants selected their preferred anesthetic delivery method (computer-controlled local anesthetic delivery system or conventional aspirating dental syringe) after experiencing both interventions.

  6. Willingness to recommend the preferred anesthetic delivery method

    Time frame: Immediately after completion of the second study intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Montemorelos

Other

Registry information

Official study title

Conventional Versus Computer-Assisted Dental Anesthesia: A Pilot Study of a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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