Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization
28. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
54
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Betül Şen Yavuz, DDS
- Telefonnummer: +905399887646
- E-post: dtbetulsen@gmail.com
Studiesteder
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Maltepe
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Istanbul, Maltepe, Tyrkia (Türkiye), 34854
- Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
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Ta kontakt med:
- Betul Sen Yavuz
- Telefonnummer: +905399887646
- E-post: dtbetulsen@gmail.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
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.
Andre navn:
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Aktiv 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.
|
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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Injection pain assessed using the Wong-Baker Faces Pain Rating Scale
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
11. august 2026
Primær fullføring (Antatt)
25. august 2027
Studiet fullført (Antatt)
1. november 2027
Datoer for studieregistrering
Først innsendt
16. juli 2026
Først innsendt som oppfylte QC-kriteriene
28. juli 2026
Først lagt ut (Faktiske)
29. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- tezasli2026
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