Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars (DIA-MIH)
26 juli 2026 bijgewerkt door: 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, and change in dental anxiety.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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, and dental anxiety was assessed before and after local anaesthetic administration using the Modified Child Dental Anxiety Scale.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
110
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Istanbul, Turkije (Türkiye)
- Istanbul Beykent University
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Izmir, Turkije (Türkiye), 35110
- Ege university
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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 Würzburg Category 1 or 2a and requiring either a direct resin composite restoration or a 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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 1:200,000 epinephrine, followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.
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Actieve vergelijker: 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.
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Supraperiosteal infiltration anaesthesia was performed using a standard aspirating dental syringe and a 27-gauge short needle.
One millilitre of 4% articaine with 1:200,000 epinephrine was deposited slowly into the buccal sulcus adjacent to the MIH-affected maxillary permanent first molar.
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Actieve vergelijker: 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.
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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 1:200,000 epinephrine was deposited slowly.
Adequate anaesthesia was confirmed by patient-reported lip numbness before restorative treatment was started.
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Experimenteel: 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.
|
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 1:200,000 epinephrine, followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale
Tijdsspanne: During the restorative procedure after local anesthesia administration, within the single treatment visit
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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.
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During the restorative procedure after local anesthesia administration, within the single treatment visit
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale
Tijdsspanne: At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit
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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.
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At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit
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Child-Reported Pain During Local Anaesthetic Solution Delivery Assessed Using the Wong-Baker FACES Pain Rating Scale
Tijdsspanne: During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit
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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.
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During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit
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Observer-Rated Pain-Related Behaviour During Local Anaesthetic Administration Assessed Using the FLACC Scale
Tijdsspanne: 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
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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.
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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
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Change in Dental Anxiety From Before to After Local Anaesthetic Administration Assessed Using the Modified Child Dental Anxiety Scale
Tijdsspanne: Immediately before and immediately after local anaesthetic administration, during the single treatment visit
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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), producing a total score ranging from 8 to 40.
Higher total scores indicate greater dental anxiety.
Change was calculated as the post-anaesthesia score minus the pre-anaesthesia score; negative values indicate a reduction in dental anxiety.
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Immediately before and immediately after local anaesthetic administration, during the single treatment visit
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Alp Abidin Atesci, PhD, Istanbul Beykent University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Dixit UB, Joshi AV. Efficacy of Intraosseous Local Anesthesia for Restorative Procedures in Molar Incisor Hypomineralization-Affected Teeth in Children. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S272-S277. doi: 10.4103/ccd.ccd_252_18.
- Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.
- Atesci AA, Korkut Isik B, Yilmaz DO, Gergit B, Kilic MC, Oncag RO. Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Pediatric Dentistry? Int J Paediatr Dent. 2025 Oct 25. doi: 10.1111/ipd.70048. Online ahead of print.
- Dogan S, Sahin M, Balci S. Effects of computer-assisted and conventional local anaesthesia on pain and anxiety in children with molar incisor hypomineralisation: a randomized controlled clinical trial. BMC Oral Health. 2026 May 30;26(1):1321. doi: 10.1186/s12903-026-08739-z.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
20 december 2024
Primaire voltooiing (Werkelijk)
15 april 2026
Studie voltooiing (Werkelijk)
15 april 2026
Studieregistratiedata
Eerst ingediend
26 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
26 juli 2026
Eerst geplaatst (Werkelijk)
30 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
26 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hypomineralisatie van het tandglazuur
- Ontwikkelingsstoornissen van glazuur
- Pijn
- Neurologische manifestaties
- Stomatognatische ziekten
- Tand ziekten
- Afwijkingen van het stomatognathische systeem
- Aangeboren afwijkingen
- Afwijkingen van tanden
- Gezichtspijn
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Molaire hypomineralisatie
- Kiespijn
Andere studie-ID-nummers
- MIH-DIA-RCT-2026
- 24-11/83 (Andere identificatie: Ege University Ethics Committee)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .