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Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars (DIA-MIH)

20. september 2026 opdateret af: Alp Abidin Ateşçi, Ege University

Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars: A Randomized Clinical Trial

This multicentre, randomized clinical trial compared digital intraosseous anaesthesia with conventional local anaesthetic techniques in children aged 6-12 years receiving restorative treatment for MIH-affected permanent first molars. Within the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia; within the mandibular stratum, it was compared with inferior alveolar nerve block. The primary outcome was child-reported pain during restorative treatment. Secondary outcomes included pain during needle penetration and anaesthetic solution delivery, observed pain-related behaviour, change in dental anxiety, and the requirement for supplemental local anaesthesia during restorative treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Children with an MIH-affected permanent first molar requiring restorative treatment were randomized separately within the maxillary and mandibular strata. In the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia. In the mandibular stratum, digital intraosseous anaesthesia was compared with conventional inferior alveolar nerve block. Only one MIH-affected permanent first molar was included for each child.

Pain during needle penetration, anaesthetic solution delivery, and restorative treatment was assessed using the Wong-Baker FACES Pain Rating Scale. Pain-related behavioural responses were assessed using the Face, Legs, Activity, Cry, Consolability scale. Dental anxiety was assessed using the Modified Child Dental Anxiety Scale immediately before local anaesthesia administration and immediately after completion of restorative treatment. The requirement for supplemental local anaesthesia during restorative treatment was recorded for each participant.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

110

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye)
        • Istanbul Beykent University
      • Izmir, Tyrkiet (Türkiye), 35110
        • Ege University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 12 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Children aged 6-12 years.
  • Confirmed diagnosis of molar-incisor hypomineralisation according to the European Academy of Paediatric Dentistry diagnostic criteria.
  • Presence of an MIH-affected permanent first molar classified as MIH-TNI Category 4a or 4b according to the updated Würzburg concept and requiring restorative treatment with either a direct resin composite restoration or a preformed stainless steel crown.
  • Positive or definitely positive behaviour according to the Frankl Behaviour Rating Scale.
  • No known allergy to local anaesthetics.
  • No relevant systemic disease.

Exclusion Criteria:

  • Receipt of analgesic, anxiolytic, or sedative medication within 48 hours before the treatment appointment.
  • Previous experience with intraosseous anaesthesia.
  • Presence of an acute dentoalveolar infection at the planned treatment site.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Maxillary Digital Intraosseous Anaesthesia Group

Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the maxillary arch.
Enhed: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System

Digital intraosseous anaesthesia was administered using the SleeperOne 5 computer-controlled system (Dental Hi Tec, Cholet, France). Initial mucosal anaesthesia was achieved using 0.1-0.2 mL of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte), followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.
Aktiv komparator: Conventional Maxillary Infiltration Anaesthesia Group

Children in this arm received conventional supraperiosteal infiltration anaesthesia in the buccal sulcus adjacent to one MIH-affected maxillary permanent first molar before restorative treatment.
Procedure: Conventional Maxillary Infiltration Anaesthesia

Supraperiosteal infiltration anaesthesia was performed using a standard aspirating dental syringe and a 27-gauge short needle. One millilitre of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte) was deposited slowly into the buccal sulcus adjacent to the MIH-affected maxillary permanent first molar.
Aktiv komparator: Conventional Mandibular Inferior Alveolar Nerve Block Group

Children in this arm received conventional inferior alveolar nerve block anaesthesia before restorative treatment of one MIH-affected mandibular permanent first molar.
Procedure: Conventional Inferior Alveolar Nerve Block Anaesthesia

Inferior alveolar nerve block anaesthesia was administered using a standard aspirating dental syringe and a 27-gauge long needle. One millilitre of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte) was deposited slowly. Adequate anaesthesia was confirmed by patient-reported lip numbness before restorative treatment was started.
Eksperimentel: Mandibular Digital Intraosseous Anesthesia Group

Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the mandibular arch.
Enhed: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System

Digital intraosseous anaesthesia was administered using the SleeperOne 5 computer-controlled system (Dental Hi Tec, Cholet, France). Initial mucosal anaesthesia was achieved using 0.1-0.2 mL of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte), followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale
Tidsramme: During the restorative procedure after local anesthesia administration, within the single treatment visit

Children rated the pain experienced during the restorative procedure using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
During the restorative procedure after local anesthesia administration, within the single treatment visit

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale
Tidsramme: At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit

Children rated the pain experienced during needle penetration using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit
Child-Reported Pain During Local Anaesthetic Solution Delivery Assessed Using the Wong-Baker FACES Pain Rating Scale
Tidsramme: During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit

Children rated the pain experienced during delivery of the local anaesthetic solution using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit
Observer-Rated Pain-Related Behaviour During Local Anaesthetic Administration Assessed Using the FLACC Scale
Tidsramme: During the local anaesthetic injection sequence, from needle penetration through completion of anaesthetic solution delivery, before commencement of the restorative procedure, during the single treatment visit

Pain-related behaviour was independently assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Each of the five components is scored from 0 to 2, producing a total score ranging from 0 to 10. A total score of 0 indicates a relaxed and comfortable child, 1-3 indicates mild discomfort, 4-6 indicates moderate pain, and 7-10 indicates severe pain. Higher scores indicate greater pain-related behavioural responses.
During the local anaesthetic injection sequence, from needle penetration through completion of anaesthetic solution delivery, before commencement of the restorative procedure, during the single treatment visit
Change in Dental Anxiety From Before Local Anaesthesia to After Completion of Restorative Treatment Assessed Using the Modified Child Dental Anxiety Scale
Tidsramme: Immediately before local anaesthetic administration and immediately after completion of restorative treatment, during the same treatment visit.

Dental anxiety was assessed using the eight-item Modified Child Dental Anxiety Scale (MCDAS). Each item is scored from 1 (relaxed) to 5 (extremely anxious), yielding a total score ranging from 8 to 40. Higher scores indicate greater dental anxiety. Change was calculated as the post-treatment score minus the pre-anaesthesia score; negative values indicate a reduction in dental anxiety.
Immediately before local anaesthetic administration and immediately after completion of restorative treatment, during the same treatment visit.
Requirement for Supplemental Local Anaesthesia During Restorative Treatment
Tidsramme: During restorative treatment following administration of the allocated anaesthetic technique, within the same treatment visit.

The number and proportion of children who required an additional local anaesthetic injection because the pain control provided by the allocated technique was considered insufficient were recorded for each treatment group.
During restorative treatment following administration of the allocated anaesthetic technique, within the same treatment visit.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ege University

Efterforskere

  • Ledende efterforsker: Alp Abidin Atesci, PhD, Istanbul Beykent University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. januar 2025

Primær færdiggørelse (Faktiske)

15. april 2026

Studieafslutning (Faktiske)

15. april 2026

Datoer for studieregistrering

Først indsendt

26. juli 2026

Først indsendt, der opfyldte QC-kriterier

26. juli 2026

Først opslået (Faktiske)

30. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MIH-DIA-RCT-2026
  • 24-11/83 (Anden identifikator: Ege University Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared. Study findings will be reported only in aggregate form to protect participant privacy, as the study involves children and no external IPD-sharing plan was established in the study protocol.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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