Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars (DIA-MIH)
26 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
110
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Istanbul, Turkiet (Türkiye)
- Istanbul Beykent University
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Izmir, Turkiet (Türkiye), 35110
- Ege university
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
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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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.
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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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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.
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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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Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Alp Abidin Atesci, PhD, Istanbul Beykent University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 december 2024
Primärt slutförande (Faktisk)
15 april 2026
Avslutad studie (Faktisk)
15 april 2026
Studieregistreringsdatum
Först inskickad
26 juli 2026
Först inskickad som uppfyllde QC-kriterierna
26 juli 2026
Första postat (Faktisk)
30 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Dental emalj hypomineralisering
- Utvecklingsdefekter av emalj
- Smärta
- Neurologiska manifestationer
- Stomatogena sjukdomar
- Tandsjukdomar
- Avvikelser i stomatogena systemet
- Medfödda abnormiteter
- Tandavvikelser
- Ansiktssmärta
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Molar hypomineralisering
- Tandvärk
Andra studie-ID-nummer
- MIH-DIA-RCT-2026
- 24-11/83 (Annan identifierare: Ege University Ethics Committee)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
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