Conventional Versus Computer-Assisted Dental Anesthesia

NCT07731503 | Completed

• 1 other identifier: UM-ESEST-2025-015
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Anesthesia, Local; Pain Measurement; Dental Anxiety; Students, Dental; Injections, Intraoral; Computer-controlled local anesthetic delivery; Split-mouth trial; Maxillary buccal infiltration

Outcome Measures

Primary Outcomes (1)

• 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".

  Immediately after each anesthetic administration

Secondary Outcomes (6)

• Dental anxiety

  Baseline (before the first study intervention)

• Systolic and diastolic blood pressure

  Before, during, and immediately after each anesthetic administration

• Heart rate

  Before, during, and immediately after anesthetic administration

• Peripheral oxygen saturation (SpO₂)

  Before, during, and immediately after anesthetic administration

• Participant-reported preferred anesthetic delivery method

  Immediately after completion of the second study intervention

Study Arms (2)

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.

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.

Device: Conventional Aspirating Dental Syringe

Interventions

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.

Also known as: SOGA-MINI

Computer-Controlled Local Anesthetic Delivery

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.

Conventional Dental Syringe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Montemorelos: lead

Study Sites (1)

University Dental Clinic, Montemorelos University School of Dentistry

Montemorelos, Nuevo León, 67530, Mexico

Location

Study Officials

• Jose L Jimenez-Ortiz, DDS

  Montemorelos University School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator responsible for assessing participant-reported outcomes (pain perception, preferred anesthetic delivery method, and willingness to recommend the preferred method) remained blinded to treatment allocation throughout the study. Participants and the care provider administering the interventions were not blinded because of the nature of the interventions. The investigator recording physiological measurements became aware of the allocated intervention during anesthetic administration because the delivery device was visible.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Member, Montemorelos University School of Dentistry

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 28, 2026
• Study Start: September 2, 2025
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

ME (1)