Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization
28. Juli 2026 aktualisiert von: Marmara University
Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial
The main questions this study aims to answer are:
Does computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)?
Is there a difference between the two methods in anesthesia onset time, injection duration, physiological responses, and the need for additional anesthesia?
Researchers will compare computer-controlled and conventional local anesthesia in children aged 8-12 years with MIH. Each child will receive both anesthesia methods during separate dental visits, on comparable permanent molar teeth, to determine which method is more comfortable, effective, and preferred by children.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This randomized split-mouth clinical trial will compare computer-controlled local anesthesia with conventional local anesthesia in children aged 8-12 years with molar-incisor hypomineralization (MIH).
Each child will receive both anesthesia methods during separate restorative treatment visits on comparable affected permanent molars. Pain will be evaluated using child-reported and behavioral pain scales. Dental anxiety, heart rate, oxygen saturation, anesthesia onset time, injection duration, need for additional anesthesia, and patient preference will also be assessed.
The study aims to determine whether computer-controlled local anesthesia provides a more comfortable and effective option than conventional anesthesia for children with MIH.
Studientyp
Interventionell
Einschreibung (Geschätzt)
54
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Betül Şen Yavuz, DDS
- Telefonnummer: +905399887646
- E-Mail: dtbetulsen@gmail.com
Studienorte
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Maltepe
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Istanbul, Maltepe, Türkei (türkiye), 34854
- Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
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Kontakt:
- Betul Sen Yavuz
- Telefonnummer: +905399887646
- E-Mail: dtbetulsen@gmail.com
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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
- Kind
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- Children aged 8-12 years
- Children with no systemic disease
- Children with no pathology involving the oral region, such as trauma, cysts, or tumors
- Children who have not used antibiotics within the past month
- Children who have not used nonsteroidal anti-inflammatory drugs (NSAIDs) within the past month
- Children with at least two homologous permanent molars affected by molar-incisor hypomineralization (MIH) and indicated for restorative treatment due to dentin caries
- Children with a Frankl Behavior Rating Scale score of 3 or higher will be included in the study
Exclusion Criteria:
- Children in whom local anesthesia cannot be administered due to lack of cooperation
- Children who require pulp treatment after enrollment in the study will be withdrawn from the study.
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: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Computer-Controlled Local Anesthesia
Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol.
The device electronically controls the injection flow rate and pressure.
A 4% articaine solution with 1:100,000 epinephrine will be used before restorative treatment of the MIH-affected permanent molar.
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Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol.
The device electronically controls the flow rate and pressure of the anesthetic solution.
A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Andere Namen:
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Aktiver Komparator: Conventional Local Anesthesia
Local anesthesia will be administered using a conventional dental syringe.
Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth.
A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
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Local anesthesia will be administered using a conventional dental syringe.
Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth.
A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Injection pain assessed using the Wong-Baker Faces Pain Rating Scale
Zeitfenster: Immediately after completion of local anesthetic injection at each treatment visit
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Pain intensity will be assessed during local anesthetic injection using the Wong-Baker Faces Pain Rating Scale (score range: 0-10; higher scores indicate greater pain).
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Immediately after completion of local anesthetic injection at each treatment visit
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Injection pain assessed using the Visual Analog Scale (VAS)
Zeitfenster: Immediately after completion of local anesthetic injection at each treatment visit
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Pain intensity will be assessed immediately after local anesthetic injection using a 100-mm Visual Analog Scale (0=no pain, 100=worst imaginable pain; higher scores indicate greater pain).
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Immediately after completion of local anesthetic injection at each treatment visit
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Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Zeitfenster: Periprocedural (during local anesthetic injection at each treatment visit)
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Behavioral pain will be assessed during local anesthetic injection using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale (score range: 0-10; higher scores indicate greater pain).
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Periprocedural (during local anesthetic injection at each treatment visit)
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Successful local anesthesia during restorative treatment
Zeitfenster: Immediately after completion of restorative treatment at each treatment visit
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Successful local anesthesia will be defined as completion of cavity preparation and restorative treatment without the need for supplemental local anesthesia and without interruption of treatment because of pain.
The outcome will be reported as the percentage of treatment visits with successful local anesthesia.
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Immediately after completion of restorative treatment at each treatment visit
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Absence of response to electric pulp testing
Zeitfenster: Immediately after completion of local anesthetic injection at each treatment visit
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The proportion of treatment visits in which no response is obtained using an electric pulp tester after local anesthetic administration.
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Immediately after completion of local anesthetic injection at each treatment visit
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Anesthesia Onset Time
Zeitfenster: Immediately following local anesthetic injection at each treatment visit.
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Anesthesia onset time will be compared between computer-controlled and conventional local anesthesia.
It will be defined as the time from completion of the injection until the child reports numbness and no response is obtained with electric pulp testing.
The time will be recorded in seconds.
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Immediately following local anesthetic injection at each treatment visit.
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Mitarbeiter und Ermittler
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Sponsor
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 (Geschätzt)
11. August 2026
Primärer Abschluss (Geschätzt)
25. August 2027
Studienabschluss (Geschätzt)
1. November 2027
Studienanmeldedaten
Zuerst eingereicht
16. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. Juli 2026
Zuerst gepostet (Tatsächlich)
29. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
29. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- tezasli2026
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