Intraosseous vs Infiltration Anesthesia in Molar-Incisor Hypomineralization (MIH) Children

NCT07352813 | Recruiting

• 1 other identifier: EK-2025-263
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of intraosseous and infiltration anesthesia techniques administered using a computer-assisted anesthesia device (SleeperOne® 5; Dental HiTec, France) during restorative treatments of permanent first molars affected by Molar-Incisor Hypomineralization (MIH) in children. Clinical effectiveness will be evaluated based on the Visual Analogue Scale (VAS), behavioral pain response, pulse rate , salivary chromogranin A levels, and the need for additional anesthesia.

Conditions

Molar Incisor Hypomineralization; Hypersensitivity

Keywords

caries; dental anxiety; dental pain; molar incisor hypomineralization

Outcome Measures

Primary Outcomes (1)

• Salivary Chromogranin A Levels

  To objectively assess the stress levels experienced by children during dental treatment, changes in salivary chromogranin A concentrations will be measured at predefined time points during the procedure.

  During dental treatment (Day 1): Baseline (before local anesthesia administration) Immediately after local anesthesia application Immediately after completion of the restorative procedure

Secondary Outcomes (5)

• Pulse Rate

  During dental treatment (Day 1): • Baseline (before local anesthesia administration) • Immediately after local anesthesia application • Throughout the restorative treatment procedure

• Visual Analogue Scale [VAS]

  During dental treatment (Day 1): Immediately after local anesthesia application Immediately after completion of the restorative procedure

• Behavioral Pain Response (FLACC Score):

  TDuring dental treatment (Day 1): Throughout the restorative treatment procedure (single assessment)

• Need for Additional Anesthesia

  During dental treatment (Day 1): Throughout the treatment procedure (single assessment)

• Anesthesia Efficacy Assessment (Efficacy Scale):

  Periprocedural (Day 1; immediately after completion of the restorative procedure)

Study Arms (2)

Intraosseous Anesthesia

EXPERIMENTAL

The intraosseous anesthesia technique will be administered using the computer-assisted anesthesia device (SleeperOne® 5) and applied to either the right or left upper permanent molar, assigned at random.

Procedure: Intraosseous anaesthesia using a computerized system

Infiltration Anesthesia

ACTIVE COMPARATOR

The infiltration anesthesia technique will be administered using the SleeperOne® 5 device and applied to the opposite side of the same patient.

Procedure: Infiltration anaesthesia using a computerized system

Interventions

Infiltration anaesthesia using a computerized system PROCEDURE

Articaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.

Infiltration Anesthesia

Intraosseous anaesthesia using a computerized system PROCEDURE

Articaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.

Intraosseous Anesthesia

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Individuals applying to the Department of Pedodontics, Ankara Yıldırım Beyazıt University Faculty of Dentistry,
• Systemically healthy individuals,
• Individuals without any known allergies,
• Children between the ages of 6 and 12 years,
• Scoring 3-4 according to the Frankl Behavior Rating Scale,
• Children and their legal guardians who, after reading and listening to the informed consent form, fully understand its content and voluntarily provide both verbal and written consent,
• Children with contralateral and homologous maxillary first permanent molars affected by molar-incisor hypomineralization (MIH) and scoring 3-4 according to the MIH Treatment Need Index criteria,
• Children with no emergency treatment needs, such as dental pain,
• Both male and female volunteers.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University Faculty of Dentistry

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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

• Cabasse C, Marie-Cousin A, Huet A, Sixou JL. Computer-assisted intraosseous anaesthesia for molar and incisor hypomineralisation teeth. A preliminary study. Odontostomatol Trop. 2015 Mar;38(149):5-9.

  PMID: 26058304 BACKGROUND

• Berrendero S, Hriptulova O, Salido MP, Martinez-Rus F, Pradies G. "Comparative study of conventional anesthesia technique versus computerized system anesthesia: a randomized clinical trial". Clin Oral Investig. 2021 Apr;25(4):2307-2315. doi: 10.1007/s00784-020-03553-5. Epub 2020 Aug 29.

  PMID: 32862249 BACKGROUND

• Rhaiem M, Chatti M, Elelmi Y, Ben Haj Khalifa A, Masmoudi F, Baaziz A. Effective anaesthesia when treating teeth affected by molar incisor hypomineralisation (MIH): a systematic review. Eur Arch Paediatr Dent. 2025 Oct;26(5):861-876. doi: 10.1007/s40368-025-01057-y. Epub 2025 May 30.

  PMID: 40445534 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization; Hypersensitivity; 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; Immune System Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe I Cihan, Professor

  Ankara Yıldırım Beyazit University Faculty of Dentistry

  STUDY CHAIR

Central Study Contacts

Gülsevim Oda, Assistant professor, pHD

CONTACT

90538948890; gulsevimoda@aybu.edu.tr

Esra Koçak

CONTACT

905350520461; esrakocak92@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 20, 2026
• Study Start: November 7, 2025
• Primary Completion (Estimated): November 7, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

TU (1)