Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars

NCT07736677 | Completed

• 2 other identifiers: MIH-DIA-RCT-202624-11/83
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Molar Incisor Hypomineralization

Keywords

Digital intraosseous anesthesia; Pediatric dentistry; Permanent molars; Dental pain; Dental anxiety

Outcome Measures

Primary Outcomes (1)

• Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale

  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

Secondary Outcomes (4)

• Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale

  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

  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

  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 to After Local Anaesthetic Administration Assessed Using the Modified Child Dental Anxiety Scale

  Immediately before and immediately after local anaesthetic administration, during the single treatment visit

Study Arms (4)

Maxillary Digital Intraosseous Anaesthesia Group

EXPERIMENTAL

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.

Device: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System

Conventional Maxillary Infiltration Anaesthesia Group

ACTIVE COMPARATOR

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

Conventional Mandibular Inferior Alveolar Nerve Block Group

ACTIVE COMPARATOR

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

Mandibular Digital Intraosseous Anesthesia Group

EXPERIMENTAL

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.

Device: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System

Interventions

SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System DEVICE

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.

Mandibular Digital Intraosseous Anesthesia Group; Maxillary Digital Intraosseous Anaesthesia Group

Conventional Maxillary Infiltration Anaesthesia PROCEDURE

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.

Conventional Maxillary Infiltration Anaesthesia Group

Conventional Inferior Alveolar Nerve Block Anaesthesia PROCEDURE

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.

Conventional Mandibular Inferior Alveolar Nerve Block Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

Istanbul Beykent University

Istanbul, Turkey (Türkiye)

Location

Ege University

Izmir, 35110, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 30883951 BACKGROUND

• 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.

  PMID: 41137566 BACKGROUND

• 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.

  PMID: 42215951 BACKGROUND

• 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.

  PMID: 30294157 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization; Toothache

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alp Abidin Atesci, PhD

  Istanbul Beykent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start: December 20, 2024
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)