Conventional Versus Computer-Assisted Dental Anesthesia
24 juli 2026 bijgewerkt door: Jose Leonardo Jimenez-Ortiz, University of Montemorelos
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
29
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Nuevo León
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Montemorelos, Nuevo León, Mexico, 67530
- University Dental Clinic, Montemorelos University School of Dentistry
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Computer-Controlled Local Anesthetic Delivery
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.
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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.
Andere namen:
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Actieve vergelijker: Conventional Dental Syringe
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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pain perception during local anesthetic administration
Tijdsspanne: Immediately after each anesthetic administration
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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".
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Immediately after each anesthetic administration
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Dental anxiety
Tijdsspanne: Baseline (before the first study intervention)
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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.
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Baseline (before the first study intervention)
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Systolic and diastolic blood pressure
Tijdsspanne: Before, during, and immediately after each anesthetic administration
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Blood pressure was measured using an automated monitor before, during, and immediately after anesthetic administration.
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Before, during, and immediately after each anesthetic administration
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Heart rate
Tijdsspanne: Before, during, and immediately after anesthetic administration
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Heart rate was measured using a pulse oximeter before, during, and immediately after anesthetic administration.
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Before, during, and immediately after anesthetic administration
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Peripheral oxygen saturation (SpO₂)
Tijdsspanne: Before, during, and immediately after anesthetic administration
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Peripheral oxygen saturation was measured using a pulse oximeter before, during, and immediately after anesthetic administration.
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Before, during, and immediately after anesthetic administration
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Participant-reported preferred anesthetic delivery method
Tijdsspanne: Immediately after completion of the second study intervention
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Participants selected their preferred anesthetic delivery method (computer-controlled local anesthetic delivery system or conventional aspirating dental syringe) after experiencing both interventions.
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Immediately after completion of the second study intervention
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Willingness to recommend the preferred anesthetic delivery method
Tijdsspanne: Immediately after completion of the second study intervention
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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.
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Immediately after completion of the second study intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jose L Jimenez-Ortiz, DDS, Montemorelos University School of Dentistry
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
2 september 2025
Primaire voltooiing (Werkelijk)
2 december 2025
Studie voltooiing (Werkelijk)
2 december 2025
Studieregistratiedata
Eerst ingediend
20 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
24 juli 2026
Eerst geplaatst (Werkelijk)
28 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
24 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- UM-ESEST-2025-015
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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