Anesthesia, Local
Conditions
Keywords
Anesthesia, Local, Pain Measurement, Dental Anxiety, Students, Dental, Injections, Intraoral, Computer-controlled local anesthetic delivery, Split-mouth trial, Maxillary buccal infiltration
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.
Interventions
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.
DEVICEConventional Aspirating Dental Syringe
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.
Sponsors
University of Montemorelos
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception during local anesthetic administration | 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
| Measure | Time frame | Description |
|---|---|---|
| Dental anxiety | 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. |
| Systolic and diastolic blood pressure | Before, during, and immediately after each anesthetic administration | Blood pressure was measured using an automated monitor before, during, and immediately after anesthetic administration. |
| Heart rate | Before, during, and immediately after anesthetic administration | Heart rate was measured using a pulse oximeter before, during, and immediately after anesthetic administration. |
| Peripheral oxygen saturation (SpO₂) | Before, during, and immediately after anesthetic administration | Peripheral oxygen saturation was measured using a pulse oximeter before, during, and immediately after anesthetic administration. |
| Participant-reported preferred anesthetic delivery method | 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. |
| Willingness to recommend the preferred anesthetic delivery method | 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. |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORJose L Jimenez-Ortiz, DDS
Montemorelos University School of Dentistry
Outcome results
None listed