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SleeperOne® 5 Intraosseous Anesthesia in MIH (CCLAD-MIH)

4. August 2026 aktualisiert von: Burcu Nihan Yüksel, Ankara University

Comparison of SleeperOne® 5-Assisted Intraosseous and Conventional Local Anesthesia for Pain and Anxiety Control in Children With Molar-Incisor Hypomineralization: A Randomized Split-Mouth Clinical Trial

This randomized split-mouth clinical trial evaluates whether computer-controlled intraosseous anesthesia delivered with the SleeperOne® 5 system reduces pain perception and dental anxiety compared with conventional local anesthesia during restorative treatment of children with molar-incisor hypomineralization (MIH). Thirty-five children received both anesthesia techniques in separate treatment sessions. Pain perception, behavioral responses, dental anxiety, pulse rate, and oxygen saturation were assessed at predefined time points.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Molar-incisor hypomineralization (MIH) is a developmental enamel defect that frequently presents with hypersensitivity, post-eruptive enamel breakdown, and an increased risk of restorative treatment failure. Achieving effective local anesthesia in children with MIH can be challenging because hypersensitive teeth often exhibit increased pain during anesthetic administration and restorative procedures. These factors may compromise patient cooperation and the quality of dental treatment.

Computer-controlled local anesthetic delivery systems have been developed to improve injection comfort by controlling the rate and pressure of anesthetic administration. The SleeperOne® 5 system allows computer-controlled intraosseous anesthesia and may provide more effective pain control than conventional local anesthesia during restorative treatment of MIH-affected teeth.

The purpose of this study was to compare SleeperOne® 5-assisted intraosseous anesthesia with conventional local anesthesia in children undergoing restorative treatment of permanent first molars affected by MIH.

The study was conducted as a randomized split-mouth clinical trial in which each participant received both anesthetic techniques during separate treatment sessions. The order of the interventions was determined using computer-generated randomization, allowing each participant to serve as his or her own control. All clinical procedures were performed under standardized conditions by the same operator.

The study was designed to evaluate whether computer-controlled intraosseous anesthesia could improve pain control and patient comfort during restorative treatment of children with MIH compared with conventional local anesthesia.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

35

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
      • Ankara, Türkei (türkiye), 06560
        • Ankara University Faculty of Dentistry

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

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Children aged 8 to 14 years.
  • Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment.
  • MIH diagnosed according to EAPD criteria.
  • Positive or definitely positive Frankl Behavior Rating Scale.
  • Parent or guardian provided written informed consent.

Exclusion Criteria:

  • Acute pulpal or periapical pathology.
  • Developmental dental anomalies other than MIH.
  • Allergy to local anesthetic agents.
  • Medical contraindication to local anesthesia.
  • Analgesic or anti-inflammatory drug use within 24 hours before treatment.
  • Cognitive or communication disorders affecting study assessments.
  • Uncooperative behavior.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: SleeperOne® 5-Assisted Intraosseous Anesthesia
Computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
Gerät: SleeperOne® 5 Computer-Controlled Intraosseous Anesthesia
Computer-controlled intraosseous local anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
Aktiver Komparator: Conventional Local Anesthesia
Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
Verfahren: Conventional Local Anesthesia
Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain Perception During Anesthetic Administration
Zeitfenster: Immediately after completion of local anesthesia administration (T1)
Pain intensity during local anesthetic administration assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Immediately after completion of local anesthesia administration (T1)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Behavioral Pain Response
Zeitfenster: Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
Behavioral pain response assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. The FLACC Scale ranges from 0 to 10, with scores of 0 indicating no pain-related behavioral distress and scores of 10 indicating severe pain-related behavioral distress. Higher scores indicate greater pain-related behavioral distress.
Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
Dental Anxiety
Zeitfenster: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
Dental anxiety assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The CFSS-DS score ranges from 15 to 75, with higher scores indicating greater dental anxiety.
Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
Pulse Rate
Zeitfenster: Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
Physiological response assessed by pulse rate (beats per minute)
Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
Peripheral Oxygen Saturation (SpO₂)
Zeitfenster: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
Physiological response assessed by peripheral oxygen saturation measured by pulse oximetry as a percentage (%). Higher values indicate greater oxygen saturation.
Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ankara University

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)

1. Januar 2024

Primärer Abschluss (Tatsächlich)

1. März 2025

Studienabschluss (Tatsächlich)

1. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

23. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juli 2026

Zuerst gepostet (Tatsächlich)

3. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 36290600/57/2023
  • TDK-2024-3458 (Andere Zuschuss-/Finanzierungsnummer: Scientific Research Projects Coordination Unit of Ankara University)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

The plan for sharing de-identified individual participant data has not yet been determined and will be considered in accordance with institutional and ethical requirements.

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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