Conventional Versus Computer-Assisted Dental Anesthesia
24. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
29
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Nuevo León
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Montemorelos, Nuevo León, Mexiko, 67530
- University Dental Clinic, Montemorelos University School of Dentistry
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pain perception during local anesthetic administration
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Dental anxiety
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Jose L Jimenez-Ortiz, DDS, Montemorelos University School of Dentistry
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
2. September 2025
Primärer Abschluss (Tatsächlich)
2. Dezember 2025
Studienabschluss (Tatsächlich)
2. Dezember 2025
Studienanmeldedaten
Zuerst eingereicht
20. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. Juli 2026
Zuerst gepostet (Tatsächlich)
28. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- UM-ESEST-2025-015
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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